- |||||||||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Journal: Microencapsulation of luteinizing hormone-releasing hormone agonist in poly (lactic-co-glycolic acid) microspheres by spray drying. (Pubmed Central) - Jan 16, 2020 Various spray drying parameters were evaluated to prepare 1-month controlled release formulations with a similar composition to the commercial Lupron Depot® (LD)...The in vitro release mechanism of the peptide was shown to be controlled either by kinetics of polymer mass loss or by a second process, hypothesized to involve peptide desorption from the polymer. These data indicate spray drying can be optimized to prepare commercially relevant PLGA microsphere formulations for delivery of peptides, including LHRHa-like leuprolide.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), nelitolimod (SD-101) / TriSalus Life Sci, UT MD Anderson Cancer Center
Trial completion date, Trial primary completion date, Combination therapy, PD(L)-1 Biomarker, Metastases: Pembrolizumab +/- SD-101 in Hormone-Na (clinicaltrials.gov) - Jan 9, 2020 P2, N=42, Recruiting, Not yet recruiting --> Recruiting Trial completion date: Apr 2022 --> Oct 2023 | Trial primary completion date: Apr 2020 --> Oct 2021
- |||||||||| Avastin (bevacizumab) / Roche
Two cases of locus minoris resistentiae in cancer metastasis (Green Room) - Jan 4, 2020 - Abstract #WSMRF2020WSMRF_112; After chemotherapy completion, she was started on maintenance therapy with Avastin due to increased tracer uptake was noted...Initial treatment included 15 cycles of radiation along with Lupron Depot and Casodex for 3 months...Identifying areas of previous tissue compromise might lead to earlier identification of metastatic disease. This could potentially lead to earlier and more effective treatment and management of such cases.
- |||||||||| Zoladex (goserelin acetate implant) / AstraZeneca, TerSera Therap, Lupron Depot (leuprorelin depot) / AbbVie, Takeda, Eligard (leuprolide acetate) / TOLMAR, Astellas, Sanofi
Survey of ADT-induced estrogen deficiency-related side effects in a contemporary cohort of men with advanced prostate cancer. (Poster Board B13) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_1097; As about half of the men have not discussed their symptoms with a physician either because of embarrassment or lack of treatment options, the number of men with moderate to severe hot flashes appears to be greatly under-reported. As men on ADT are living longer with prostate cancer, finding an effective and safe treatment for debilitating hot flashes must be a priority.
- |||||||||| Zoladex (goserelin acetate implant) / AstraZeneca, TerSera Therap, Lupron Depot (leuprorelin depot) / AbbVie, Takeda, Eligard (leuprolide acetate) / TOLMAR, Astellas, Sanofi
Survey of ADT-induced estrogen deficiency-related side effects in a contemporary cohort of men with advanced prostate cancer. (Poster Board B13) - Dec 22, 2019 - Abstract #ASCOGU2020ASCO_GU_815; As about half of the men have not discussed their symptoms with a physician either because of embarrassment or lack of treatment options, the number of men with moderate to severe hot flashes appears to be greatly under-reported. As men on ADT are living longer with prostate cancer, finding an effective and safe treatment for debilitating hot flashes must be a priority.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., bicalutamide / Generic mfg., docetaxel / Generic mfg.
Enrollment closed, Metastases: oligo-mets: A Study of Definitive Therapy to Treat Prostate Cancer (clinicaltrials.gov) - Dec 12, 2019 P2, N=26, Active, not recruiting, As men on ADT are living longer with prostate cancer, finding an effective and safe treatment for debilitating hot flashes must be a priority. Recruiting --> Active, not recruiting
- |||||||||| Enrollment closed, Trial completion date, Trial primary completion date, Surgery, Metastases: Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery) (clinicaltrials.gov) - Dec 5, 2019
P2, N=200, Active, not recruiting, N=150 --> 79 Recruiting --> Active, not recruiting | Trial completion date: Mar 2019 --> Mar 2023 | Trial primary completion date: Mar 2019 --> Mar 2020
- |||||||||| Erleada (apalutamide) / J&J
Enrollment closed: c15-164: AASUR in High Risk Prostate Cancer (clinicaltrials.gov) - Nov 22, 2019 P2, N=64, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Mar 2019 --> Mar 2023 | Trial primary completion date: Mar 2019 --> Mar 2020 Recruiting --> Active, not recruiting
- |||||||||| Herceptin (trastuzumab) / Roche, Kisqali (ribociclib) / Novartis, Perjeta (pertuzumab) / Roche
Trial completion date, Combination therapy, Metastases: Detect V / CHEVENDO (Chemo vs. Endo) (clinicaltrials.gov) - Oct 27, 2019 P3, N=270, Recruiting, Trial completion date: Sep 2019 --> Jun 2020 Trial completion date: Sep 2021 --> Jun 2023
- |||||||||| Yervoy (ipilimumab) / Ono Pharma, BMS
Trial termination: Ipilimumab + Androgen Depravation Therapy in Prostate Cancer (clinicaltrials.gov) - Oct 9, 2019 P2, N=30, Terminated, Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020 Completed --> Terminated; Due to adverse events
- |||||||||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Journal: Reverse Engineering the 1-Month Lupron Depot®. (Pubmed Central) - Sep 26, 2019 Very low content of residual moisture (< 0.5%) and methylene chloride (< 1 ppm) in the product indicates in-water drying is capable of removing solvents to extremely low levels during manufacturing. The rigorous approach of reverse engineering described here may be useful for development of generic leuprolide-PLGA microspheres as well as other new and generic PLGA microsphere formulations.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Trial completion date, Trial primary completion date: Brown Adipose Tissue Activity in Pre- and Postmenopausal Women (clinicaltrials.gov) - Sep 26, 2019 P=N/A, N=72, Recruiting, The rigorous approach of reverse engineering described here may be useful for development of generic leuprolide-PLGA microspheres as well as other new and generic PLGA microsphere formulations. Trial completion date: Aug 2019 --> Aug 2020 | Trial primary completion date: Aug 2019 --> Aug 2020
- |||||||||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Prostate Cancer in an Incarcerated Population: Patient Characteristics and Treatment (ASTRO Innovation Hub) - Sep 24, 2019 - Abstract #ASTRO2019ASTRO_3712; As no prostate screening system is in place ,these more advanced malignancies likely represent the natural history of an unscreened population, which also appears to be the trend in the general population. All incarcerated patients in this study have been treated as per national guidelines.
- |||||||||| Sutent (sunitinib) / Pfizer
Trial completion date, Trial primary completion date: Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy (clinicaltrials.gov) - Sep 18, 2019 P2, N=64, Active, not recruiting, Trial completion date: Jul 2021 --> Oct 2021 | Trial primary completion date: Jul 2021 --> Oct 2021 Trial completion date: May 2019 --> Dec 2019 | Trial primary completion date: May 2019 --> Dec 2019
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