leuprolide acetate for depot suspension News

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|||||||||| leuprolide acetate for depot suspension / Generic mfg.
Retrospective data, Journal: Efficacy and safety of leuprorelin 3-month depot (11.25?mg) for idiopathic central precocious puberty treatment of Chinese girls: a single-center retrospective study. (Pubmed Central) - Nov 17, 2023
Three-month leuprorelin acetate is a safe and effective treatment for suppressing the pituitary-gonadal axis and restoring impaired adult height in Chinese girls.

||||||||||  goserelin acetate / Generic mfg., leuprolide acetate for depot suspension / Generic mfg., bicalutamide / Generic mfg.
Trial completion, Surgery:  RADICALS-HD: RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery (clinicaltrials.gov) -  Nov 12, 2023
P3, N=4236, Completed,  Sponsor: University College, London
Three-month leuprorelin acetate is a safe and effective treatment for suppressing the pituitary-gonadal axis and restoring impaired adult height in Chinese girls. Unknown status --> Completed

|||||||||| leuprolide acetate for depot suspension / Generic mfg., norethindrone / Generic mfg.
Journal: Menstrual Suppression in Adolescent and Young Adult Transgender Males. (Pubmed Central) - Nov 8, 2023
Less than half achieved cessation of menses within 6 months. NETA and depot leuprolide users reported the most rapid cessation of menses.

|||||||||| leuprolide acetate for depot suspension / Generic mfg.
Effects of a two-year period Hybrid Assistive Limb use on gait in patients with spinal and bulbar muscular atrophy (Event Halle, Messe Basel, Ground Floor) - Nov 7, 2023 - Abstract #ALSMND2023ALS_MND_460;
In combination with leuprorelin therapy, robotassisted training using the HAL maintained the gait ability in 3 patients with SBMA for 2 years. musicallow@med.toho-u.ac.jp 222 Clinical Trials and Trial Design 34th International Symposium on ALS/MND

|||||||||| Verzenio (abemaciclib) / Eli Lilly
Concerning Discrepancies in Estradiol Levels in Premenopausal Women Receiving Abemaciclib and Ovarian Function Suppression (Hall 2-3) - Nov 4, 2023 - Abstract #SABCS2023SABCS_1694;
As up to 91% of patients in our study may have had a false positive estradiol level erroneously suggesting inadequate OFS, monitoring of estradiol levels using the CMIA assay in patients receiving adjuvant abemaciclib in addition to OFS could lead to changes in therapy that may be unnecessary. It is recommended that the LC-MS/MS assay be used when monitoring of estradiol levels is indicated in patients receiving abemaciclib concurrently with OFS.

|||||||||| Ibrance (palbociclib) / Pfizer, Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead
Hiding in plain sight: A heterogeneous response in a patient with metastatic HR+/HER2- breast cancer (Hall 2-3) - Nov 4, 2023 - Abstract #SABCS2023SABCS_967;
It is recommended that the LC-MS/MS assay be used when monitoring of estradiol levels is indicated in patients receiving abemaciclib concurrently with OFS. She tolerated one week of tamoxifen which was discontinued due to adverse effects...Patient was started on letrozole with lupron and palbociclib with disease control for two years until progression in the bone, prompting a switch of letrozole to fulvestrant with continued palbociclib...She was then started on single-agent paclitaxel...She opted to enroll into a Phase 1b/2 trial with sacituzumab govitecan-hziy in combination with a PARPi...A history of mixed response in the liver was concluded to be two coexisting neoplasms

||||||||||  Xtandi (enzalutamide) / Pfizer, Astellas
Trial completion, Trial completion date, Trial primary completion date, HEOR, Real-world evidence:  Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (clinicaltrials.gov) -  Nov 3, 2023
P=N/A, N=1, Completed,  Sponsor: Pfizer
She tolerated one week of tamoxifen which was discontinued due to adverse effects...Patient was started on letrozole with lupron and palbociclib with disease control for two years until progression in the bone, prompting a switch of letrozole to fulvestrant with continued palbociclib...She was then started on single-agent paclitaxel...She opted to enroll into a Phase 1b/2 trial with sacituzumab govitecan-hziy in combination with a PARPi...A history of mixed response in the liver was concluded to be two coexisting neoplasms Recruiting --> Completed | Trial completion date: Nov 2023 --> Jun 2023 | Trial primary completion date: Nov 2023 --> Jun 2023

|||||||||| Campath (alemtuzumab) / Sanofi
Favorable Fertility Outcome in a Large Cohort of Sickle Cell Disease Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (SDCC - Room 7) - Nov 3, 2023 - Abstract #ASH2023ASH_1267;
Recruiting --> Completed | Trial completion date: Nov 2023 --> Jun 2023 | Trial primary completion date: Nov 2023 --> Jun 2023 The conditioning regimen was alemtuzumab 1 mg /kg divided over 5 days from day

|||||||||| enzalutamide capsule / Generic mfg.
Journal, Metastases: Enzalutamide-Induced Acute Maculopapular Rash in Treatment of Metastatic Prostate Cancer: First Case Report from a Tertiary Cancer Care Center of North India. (Pubmed Central) - Oct 30, 2023
Most common among these are apalutamide...He was started on Degarelix subcutaneous injection with oral abiraterone initially...Intramuscular Injection leuprolide was started and initial responses were good followed by later rise of PSA from January...Rather, it should be with stopped for 10-14 days. Basic treatment with anti-histaminics or topical steroids may be enough to warranty the resolution of symptoms, and the drug (Enzalutamide) can be continued thereafter.

|||||||||| New trial: GnRH-a on Angiogenesis of Endometriosis (clinicaltrials.gov) - Oct 29, 2023
P=N/A, N=60, Completed, Sponsor: University of Patras

|||||||||| leuprolide acetate for depot suspension / Generic mfg., mitoxantrone / Generic mfg.
Journal: Rational Design, Synthesis and Binding Affinity Studies of Anthraquinone Derivatives Conjugated to Gonadotropin-Releasing Hormone (GnRH) Analogues towards Selective Immunosuppression of Hormone-Dependent Cancer. (Pubmed Central) - Oct 28, 2023
Among the mitoxantrone based GnRH conjugates, con3 and con7 show the highest affinities at 0.07 and 0.06 nM, respectively, while the disulfide bond present in the conjugates is found to be readily reduced by the thioredoxin (Trx) system. These findings are promising for further pharmacological evaluation of the synthesized conjugates with the prospect of performing future clinical studies.

|||||||||| enzalutamide capsule / Generic mfg.
Journal: Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. (Pubmed Central) - Oct 22, 2023
P3
The safety profile of enzalutamide was consistent with that shown in previous clinical studies, with no apparent detrimental effect on quality of life. (Funded by Pfizer and Astellas Pharma; EMBARK ClinicalTrials.gov number, NCT02319837.).

||||||||||  Kisqali (ribociclib) / Novartis
Trial initiation date, Trial primary completion date, Real-world evidence:  ADJUVANT WIDER: Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (clinicaltrials.gov) -  Oct 16, 2023
P3, N=2500, Not yet recruiting,  Sponsor: Novartis Pharmaceuticals
(Funded by Pfizer and Astellas Pharma; EMBARK ClinicalTrials.gov number, NCT02319837.). Initiation date: Sep 2023 --> Jan 2024 | Trial primary completion date: Jun 2030 --> Jul 2028

|||||||||| Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
P3 data, Journal, Metastases: Relugolix vs. Leuprolide Effects on Castration Resistance-Free Survival from the Phase 3 HERO Study in Men with Advanced Prostate Cancer. (Pubmed Central) - Oct 14, 2023
In men with metastatic disease or in the overall population of the HERO study, CRFS assessed during the 48-week treatment with relugolix was not significantly different than standard-of-care leuprolide. Relugolix had similar efficacy for men with/without CRFS progression events.

|||||||||| leuprolide acetate for depot suspension / Generic mfg., Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
P3 data, Journal, HEOR, Metastases: Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study. (Pubmed Central) - Oct 14, 2023
Relugolix had similar efficacy for men with/without CRFS progression events. Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction.

||||||||||  sunitinib / Generic mfg.
Trial completion date, Trial primary completion date:  Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy (clinicaltrials.gov) -  Oct 13, 2023
P2, N=64, Active, not recruiting,  Sponsor: M.D. Anderson Cancer Center
Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

|||||||||| leuprolide acetate for depot suspension / Generic mfg., zoledronic acid / Generic mfg., fulvestrant / Generic mfg.
End-of-life chemotherapy and palliative care utilization among patients with breast cancer treated at a safety-net system. (3rd Floor, Back Bay Hall; Poster Bd #: H4) - Oct 13, 2023 - Abstract #ASCOQC2023ASCO_QC_502;
In addition, less than half of the patients in our study completed a palliative care visit before death. Late palliative care referral, timely access, understanding the benefit of the service, low health literacy, language barrier, cultural considerations, and physicians

||||||||||  docetaxel / Generic mfg.
Trial completion date, Metastases:  Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer (clinicaltrials.gov) -  Oct 12, 2023
P1, N=20, Active, not recruiting,  Sponsor: Medical University of South Carolina
Late palliative care referral, timely access, understanding the benefit of the service, low health literacy, language barrier, cultural considerations, and physicians Trial completion date: Sep 2023 --> Dec 2023

|||||||||| Trial completion, Enrollment change, Trial completion date, Trial primary completion date: STAMP: Strength, Aging, and Memory in Prostate Cancer (clinicaltrials.gov) - Oct 12, 2023
P=N/A, N=20, Completed, Sponsor: University of Nebraska
Trial completion date: Sep 2023 --> Dec 2023 Active, not recruiting --> Completed | N=60 --> 20 | Trial completion date: Jul 2024 --> Apr 2023 | Trial primary completion date: Jul 2024 --> Apr 2023

|||||||||| isotretinoin / Generic mfg.
Preclinical, Journal: The protective effects of hormonal suppression by a gonadotropin-releasing hormone agonist or an oral contraceptive on the decreased ovarian reserve in female rats exposed to isotretinoin. (Pubmed Central) - Oct 6, 2023
Active, not recruiting --> Completed | N=60 --> 20 | Trial completion date: Jul 2024 --> Apr 2023 | Trial primary completion date: Jul 2024 --> Apr 2023 Our results show that GnRH agonists or COC have no protective effects on ovarian reserve when co-administered with isotretinoin in the rat model.

|||||||||| leuprolide acetate for depot suspension / Generic mfg.
Biomarker, Journal, HEOR: Testosterone as a Biomarker for Quality of Life (QOL) Following Androgen Deprivation Therapy (ADT) and Stereotactic Body Radiotherapy (SBRT). (Pubmed Central) - Oct 4, 2023
Our results show that GnRH agonists or COC have no protective effects on ovarian reserve when co-administered with isotretinoin in the rat model. Testosterone recovery following short-course ADT

|||||||||| Erleada (apalutamide) / J&J
P2 data, Journal, Metastases: Tolerability of Metastasis-Directed Stereotactic Body Radiotherapy with Short-Course Triple-Agent Androgen Annihilation Therapy in Recurrent Oligometastatic Prostate Cancer: Secondary Analysis of a Phase II Study. (Pubmed Central) - Oct 3, 2023
Some patients experienced acute grade 3 toxicities, the most common being drug-related skin rashes and hypertension. While efficacy data are needed to evaluate the oncologic benefit, these data suggest a short course of AAT is considerably better tolerated than longer courses of AAT, with grade 3 toxicity rates similar to long courses of single-agent androgen deprivation therapy alone.

|||||||||| enzalutamide capsule / Generic mfg., leuprolide acetate for depot suspension / Generic mfg.
Enzalutamide or Placebo Plus Leuprolide Acetate and Enzalutamide Monotherapy in Men with High-Risk Biochemically Recurrent Prostate Cancer and Prior Radiotherapy: EMBARK Subgroup Analysis (Ballroom 20) - Oct 2, 2023 - Abstract #ASTRO2023ASTRO_2623;
P3
In patients without prior RT, the number of MFS events was too low to draw any conclusions. If approved, enza combination therapy may represent a new standard of care for patients with high-risk BCR and prior RT.

|||||||||| leuprolide acetate for depot suspension / Generic mfg.
Preclinical, Journal: Puberty suppression followed by testosterone therapy does not impair reproductive potential in female mice. (Pubmed Central) - Sep 28, 2023
This study used a translational murine IVF model to examine the effects of female puberty suppression with depot leuprolide acetate (LA), followed by virilizing therapy with testosterone cypionate (T), on embryologic and pregnancy outcomes...Eggs from mice treated with LA and T were fertilizable and produced developmentally competent embryos that led to births of fertile pups. These results suggest that fertility may not be impaired after puberty suppression and cross-hormone therapy for transgender males.

|||||||||| KPG-121 / Kangpu Biopharma
A case report of metastatic castration resistant prostate cancer patient with AR F877L mutation treated with KPG-121 in combination with enzalutamide (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1227;
P1
than lenalidomide in vitro...The patient had a medical history of osteoarthritis and his prior treatments included bicalutamide, leuprorelin, sipuleucel-T, enzalutamide, and intensity-modulated radiotherapy. The patient

||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment closed, Trial completion date, Trial primary completion date:  PRIME-CUT: REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer (clinicaltrials.gov) -  Sep 25, 2023
P2, N=20, Active, not recruiting,  Sponsor: Mark Stein
The patient Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Apr 2028 | Trial primary completion date: Dec 2022 --> Mar 2024

||||||||||  Kisqali (ribociclib) / Novartis
Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy, Metastases:  FACILE: FeAsibility of First-line riboCIclib in oLdEr Patients With Advanced Breast Cancer (clinicaltrials.gov) -  Sep 22, 2023
P2, N=116, Active, not recruiting,  Sponsor: Fondazione Sandro Pitigliani
Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Apr 2028 | Trial primary completion date: Dec 2022 --> Mar 2024 Recruiting --> Active, not recruiting | N=194 --> 116 | Trial primary completion date: Dec 2022 --> Dec 2024

||||||||||  Yselty (linzagolix) / Kissei, Theramex, Syneos Health
Enrollment closed:  A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia (clinicaltrials.gov) -  Sep 21, 2023
P3, N=264, Active, not recruiting,  Sponsor: Kissei Pharmaceutical Co., Ltd.
Recruiting --> Active, not recruiting | N=194 --> 116 | Trial primary completion date: Dec 2022 --> Dec 2024 Recruiting --> Active, not recruiting

|||||||||| leuprolide acetate for depot suspension / Generic mfg.
Journal: Comparison of the effects of two different trigger strategies - dual (hCG + Leuprolide) versus hCG trigger - in antagonist non-donor IVF: a randomized controlled trial. (Pubmed Central) - Sep 16, 2023
Recruiting --> Active, not recruiting This study found that the addition of GnRHa to hCG trigger leads to improved embryological outcomes and the possibility of cryopreserving surplus embryos, thereby increasing cumulative live births.

|||||||||| Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
Journal, Metastases: Impact of Concomitant Cardiovascular Therapies on Efficacy and Safety of Relugolix vs Leuprolide: Subgroup Analysis from HERO Study in Advanced Prostate Cancer. (Pubmed Central) - Sep 15, 2023
P3
This study found that the addition of GnRHa to hCG trigger leads to improved embryological outcomes and the possibility of cryopreserving surplus embryos, thereby increasing cumulative live births. Relugolix suppressed testosterone and was generally well tolerated when given with concomitant CV agents.

||||||||||  Keytruda (pembrolizumab) / Merck (MSD), nelitolimod (SD-101) / TriSalus Life Sci, UT MD Anderson Cancer Center
Trial completion date, Trial primary completion date:  Pembrolizumab +/- SD-101 in Hormone-Na (clinicaltrials.gov) -  Sep 14, 2023
P2, N=23, Active, not recruiting,  Sponsor: Lawrence Fong
Relugolix suppressed testosterone and was generally well tolerated when given with concomitant CV agents. Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024

||||||||||  leuprolide acetate for depot suspension / Generic mfg.
New P3 trial:  Evaluate the Efficacy and Safety of DWJ108J (clinicaltrials.gov) -  Sep 6, 2023
P3, N=79, Recruiting,  Sponsor: Daewoong Pharmaceutical Co. LTD.

||||||||||  Truqap (capivasertib) / Otsuka, AstraZeneca
Trial initiation date:  SNARE: A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (clinicaltrials.gov) -  Sep 1, 2023
P2, N=30, Not yet recruiting,  Sponsor: VA Office of Research and Development
Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024 Initiation date: Jun 2023 --> Oct 2023

||||||||||  Xtandi (enzalutamide capsule) / Pfizer, Astellas, Rubraca (rucaparib) / Pharma& Schweiz
Trial suspension, Metastases:  CASPAR: A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy (clinicaltrials.gov) -  Aug 31, 2023
P3, N=1002, Suspended,  Sponsor: Alliance for Clinical Trials in Oncology
Initiation date: Jun 2023 --> Oct 2023 Recruiting --> Suspended

||||||||||  Estrace (estradiol) / AbbVie
Enrollment change:  Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model (clinicaltrials.gov) -  Aug 25, 2023
P2, N=23, Completed,  Sponsor: University of North Carolina, Chapel Hill
Recruiting --> Suspended N=52 --> 23

|||||||||| Erleada (apalutamide) / J&J
Tolerability of Metastasis-Directed Stereotactic Body Radiotherapy with Short-Course Triple-Agent Androgen Annihilation Therapy in Recurrent Oligometastatic Prostate Cancer: Secondary Analysis of a Ph (Hall B2; In Person Only; Screen: 22) - Aug 22, 2023 - Abstract #ASTRO2023ASTRO_1571;
Some patients experienced acute grade 3 toxicities, the most common being drug-related skin rashes and hypertension. While efficacy data are needed to evaluate the oncologic benefit, these data suggest a short course of AAT is considerably better tolerated than longer courses of AAT, with grade 3 toxicity rates similar to long courses of single-agent androgen deprivation therapy alone.

||||||||||  Xtandi (enzalutamide) / Pfizer, Astellas
Trial initiation date:  ARCH: Contributions to Hypertension With Androgen Deprivation Therapy (clinicaltrials.gov) -  Aug 18, 2023
P4, N=228, Not yet recruiting,  Sponsor: University of Colorado, Denver
While efficacy data are needed to evaluate the oncologic benefit, these data suggest a short course of AAT is considerably better tolerated than longer courses of AAT, with grade 3 toxicity rates similar to long courses of single-agent androgen deprivation therapy alone. Initiation date: Jul 2023 --> Oct 2023

|||||||||| Victoza (liraglutide) / Novo Nordisk, Suprefact (buserelin acetate) / Sanofi
Review, Journal: Hormonal Treatments in Hidradenitis Suppurativa: A Systematic Review. (Pubmed Central) - Aug 13, 2023
Anti-androgen treatments discussed include finasteride (n=8), spironolactone (n=7), cyproterone acetate (CPA) (n=5), flutamide (n=1), leuprolide (n=1), and buserelin acetate (n=1)...Improvement in HS was also noted in case reports of patients treated with buserelin acetate, leuprolide, flutamide, and liraglutide. Hormonal treatments for HS, especially finasteride, spironolactone, and metformin, are efficacious and safe; but large-scale randomized controlled trials are needed to determine the patient populations which would benefit from these therapies...2023;22(8):785-794. doi:10.36849/JDD.7325.

|||||||||| Visanne (dienogest) / Mochida, Bayer, Mifeprex (mifepristone) / Danco Laboratories
Retrospective data, Review, Journal, Surgery: Efficacy and safety of different subsequent therapies after fertility preserving surgery for endometriosis: A systematic review and network meta-analysis. (Pubmed Central) - Aug 10, 2023
For patients after fertility preserving surgery for EMT, the recurrence rate of dienogest was the last place with highest preference. The first rank of dienogest pregnancy was the highest.

|||||||||| PULMONARY BENIGN METASTASIZING LEIOMYOMA (Convention Center Exhibit Hall) - Aug 4, 2023 - Abstract #CHEST2023CHEST_1458;

|||||||||| BENIGN METASTASIZING LEIOMYOMA (Convention Center Exhibit Hall) - Aug 4, 2023 - Abstract #CHEST2023CHEST_1262;

||||||||||  trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma, tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
Enrollment open, Trial completion date, Trial primary completion date, Metastases:  A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) -  Aug 2, 2023
P2, N=66, Recruiting,  Sponsor: Fudan University
The first rank of dienogest pregnancy was the highest. Not yet recruiting --> Recruiting | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025

||||||||||  Welireg (belzutifan) / Merck (MSD)
Trial completion date, Trial initiation date, Trial primary completion date:  A Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional Prostate Cancer (clinicaltrials.gov) -  Aug 1, 2023
P2, N=30, Not yet recruiting,  Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Not yet recruiting --> Recruiting | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025 Trial completion date: Jul 2025 --> Jul 2026 | Initiation date: Jul 2023 --> Jan 2024 | Trial primary completion date: Jan 2024 --> Jan 2025

||||||||||  leuprolide acetate for depot suspension / Generic mfg.
Trial completion, Metastases:  BSV_LEUPR_18_05: Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer (clinicaltrials.gov) -  Aug 1, 2023
P3, N=155, Completed,  Sponsor: Bharat Serums and Vaccines Limited
Trial completion date: Jul 2025 --> Jul 2026 | Initiation date: Jul 2023 --> Jan 2024 | Trial primary completion date: Jan 2024 --> Jan 2025 Recruiting --> Completed

|||||||||| Ibrance (palbociclib) / Pfizer, Avastin (bevacizumab) / Roche, Halaven (eribulin mesylate) / Eisai
Journal, BRCA Biomarker, PD(L)-1 Biomarker, IO biomarker: A Case of Breast Carcinoma That Changed Subtype to Squamous Cell Carcinoma after Chemotherapy (Pubmed Central) - Jul 31, 2023
left breast cancer T2N2bM1(HEP)(ER 90%, PR 70%, HER2 2+, FISH-)at another hospital and participated in the PATHWAY study(tamoxifen plus goserelin plus palbociclib/placebo)...She was treated at our hospital thereafter, with capecitabine plus cyclophosphamide, palbociclib plus fulvestrant plus leuprorelin, paclitaxel plus bevacizumab, eribulin, EC therapy, and docetaxel...Therefore, left mastectomy plus pectoralis major muscle resection was performed. The patient died one month after the operation.

|||||||||| leuprolide acetate for depot suspension / Generic mfg.
Recurrent Hemorrhagic Abdominal Ascites Secondary to Poorly-Controlled Endometriosis (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_4458;
Her outpatient therapy with Leuprolide was inconsistent due to financial difficulty...Surgical intervention is the more definitive treatment but most females affected are nulliparous and typically do not opt for radical surgery. Due to the debilitating nature of this disease, clinical suspicion should be high, and patients should be made aware of all treatment options including hormonal and surgical.

|||||||||| Development of Celiac Disease After Immunotherapy for Psoriasis, Breast Cancer, and Renal Cell Carcinoma: A Case Series (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_1756;
Case Description/ A 21 year old female with psoriasis on ixekizumab (IL-17A antagonist) and recent dose of risankizumab (IL-23A antibody) presented with abdominal pain, diarrhea, and bloating...Colonoscopy showed lymphocytic colitis, and she started budesonide and gluten free diet with some improvement...A 49 year old female with invasive ductal carcinoma was treated with leuprolide, exemestane, trastuzumab and pertuzumab (anti-HER2 antibodies) and developed severe watery diarrhea requiring hospitalization for electrolyte abnormalities and total parenteral nutrition...An 82 year old male with metastatic renal cell carcinoma was treated with axitinib, complicated by diarrhea requiring dose reduction, and pembrolizumab, discontinued due to colitis requiring prednisone, then cabozantinib, complicated by diarrhea which persisted after dose reduction...Figure: Figure: Duodenal Biopsy of Case 3, Celiac Disease in an 82 year old male with metastatic renal cell carcinoma treated with axitinib, pembrolizumab, and cabozantinib. (A) Routine H&E staining of a duodenal biopsy showed subtotal to total villous atrophy, (B) Duodenal biopsy with thickened sub-epithelial collagen layer highlighted on trichrome stain, (C) Duodenal biopsy with intraepithelial lymphocytosis confirmed by CD3 immunohistochemistry Table: Immunotherapies and Presentations of Celiac Disease

||||||||||  Opdivo (nivolumab) / BMS
Trial primary completion date:  Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov) -  Jul 28, 2023
P2, N=60, Recruiting,  Sponsor: Xiao X. Wei, MD
(A) Routine H&E staining of a duodenal biopsy showed subtotal to total villous atrophy, (B) Duodenal biopsy with thickened sub-epithelial collagen layer highlighted on trichrome stain, (C) Duodenal biopsy with intraepithelial lymphocytosis confirmed by CD3 immunohistochemistry Table: Immunotherapies and Presentations of Celiac Disease Trial primary completion date: Jun 2023 --> Jun 2024

||||||||||  Erleada (apalutamide) / J&J
Trial completion date, Trial primary completion date:  SOLAR: Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer (clinicaltrials.gov) -  Jul 28, 2023
P2, N=28, Active, not recruiting,  Sponsor: VA Office of Research and Development
Trial primary completion date: Jun 2023 --> Jun 2024 Trial completion date: Jun 2023 --> Mar 2024 | Trial primary completion date: Sep 2022 --> Mar 2024

|||||||||| Enrollment closed, Surgery: PLATO: PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate (clinicaltrials.gov) - Jul 27, 2023
P2, N=122, Active, not recruiting, Sponsor: Seoul National University Hospital
Trial completion date: Jun 2023 --> Mar 2024 | Trial primary completion date: Sep 2022 --> Mar 2024 Recruiting --> Active, not recruiting



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