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- | gedatolisib (PF-05212384) / Celcuity
Preclinical, Journal, PARP Biomarker: Synthesis, Molecular Docking, In Vitro and In Vivo Studies of Novel Dimorpholinoquinazoline-Based Potential Inhibitors of PI3K/Akt/mTOR Pathway. (Pubmed Central) - Oct 1, 2022
In vivo studies demonstrated an inhibition of tumor growth in the colorectal tumor model. According to the docking studies, the replacement of the triazine core in gedatolisib (8) by a quinazoline fragment, and incorporation of a (hetero)aromatic unit connected with the carbamide group via a flexible spacer, can result in more selective inhibition of the PI3Kα isoform.
- |||||||||| gedatolisib (PF-05212384) / Celcuity
New P3 trial, Metastases: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) (clinicaltrials.gov) - Aug 16, 2022
P3, N=701, Not yet recruiting, Sponsor: Celcuity, Inc.
- || cofetuzumab pelidotin (ABBV-647) / Pfizer, AbbVie, gedatolisib (PF-05212384) / Celcuity
P1 data, Journal: Initial phase I safety study of gedatolisib plus cofetuzumab pelidotin for patients with metastatic triple-negative breast cancer. (Pubmed Central) - Aug 6, 2022
The combination of gedatolisib + cofetuzumab pelidotin was well tolerated and demonstrated promising clinical activity. Further investigation of this drug combination in metastatic TNBC is warranted.
- |||||||||| gedatolisib (PF-05212384) / Celcuity
New P3 trial, Metastases: VIKTORIA-1: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov) - Aug 3, 2022
P3, N=701, Recruiting, Sponsor: Celcuity, Inc.
- omipalisib (GSK2126458) / GSK
OMIPALISIB, A DUAL PI3K/MTOR INHIBITOR, TARGETS MITOCHONDRIA AND IMPAIRS OXIDATIVE PHOSPHORYLATION IN ACUTE MYELOID LEUKEMIA () - May 13, 2022 - Abstract #EHA2022EHA_783;
Our results indicate that omipalisib could suppress cell proliferation not only through PI3K-AKT-mTOR signaling but also via impairing mitochondrial biogenesis. This information may be potentially suitable for future clinical applications.
- Talzenna (talazoparib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
Results of the safety run-in of gedatolisib plus talazoparib in advanced triple negative or BRCA 1/2 positive HER2 negative breast cancer. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1246;
P1/2
This combination therapy has moved into the phase II trial, with 2 cohorts. Cohort A includes BRCA-wildtype patients with TNBC and cohort 2 includes those with a BRCA mutation and HER2-negative disease.
- | Taltorvic (ridaforolimus) / Takeda, Merck (MSD), gedatolisib (PF-05212384) / Celcuity, Torisel (temsirolimus) / Pfizer
Journal: Structural Aspects of mTOR Inhibitors: In Progress to Search Potential Compounds. (Pubmed Central) - Apr 13, 2022
The mTOR inhibitors bearing heterocyclic moieties such as quinazoline, thiophene, morpholine, imidazole, pyrazine, furan, quinoline are under investigation against various cancer cell lines (U87MG, PC-3, MCF-7, A549, MDA-231). In this review, we summarized updated research related to mTOR inhibitors, their structure-activity relationship which may help scientists for the development of potent inhibitors against cancer.
- | gedatolisib (PF-05212384) / Celcuity
Preclinical, Journal: The PI3K/mTOR inhibitor Gedatolisib eliminates dormant breast cancer cells in organotypic culture, but fails to prevent metastasis in preclinical settings. (Pubmed Central) - Apr 9, 2022
These data suggest that PI3K is not the node downstream of integrin-β1 that confers chemotherapeutic resistance to DTCs. More broadly, they cast doubt on the strategy to target PI3K in order to eliminate DTCs and prevent breast cancer metastasis.
- || gedatolisib (PF-05212384) / Celcuity
Clinical, P1 data, Journal, Combination therapy: Phase 1 Dose-Escalation Study of the dual PI3K-mTORC1/2 inhibitor Gedatolisib in combination with Paclitaxel and Carboplatin in Patients with Advanced Solid Tumors. (Pubmed Central) - Apr 2, 2022
More broadly, they cast doubt on the strategy to target PI3K in order to eliminate DTCs and prevent breast cancer metastasis. Gedatolisib combined with carboplatin and paclitaxel is tolerable and preliminary efficacy was observed especially in CCOC.
- PI3K/AKT/mTOR pathway and CDK4/6 inhibitors efficiently inhibit cell growth of HPV-positive and HPV-negative head and neck squamous cell carcinoma in vitro (Section 21) - Mar 9, 2022 - Abstract #AACR2022AACR_4738;
Whereas PI3Ki especially show an effect on oxidative and glycolytic metabolism, CDKi particularly lead to cell cycle arrest. Further research should elucidate whether these inhibitors may be effective therapeutic agents in HNSCC patients.
- ||| gedatolisib (PF-05212384) / Celcuity
The potent, reversible dual inhibitor, Gedatolisib, selectively targets all class I isoforms of PI3K and mTOR @US_FDA #bcsm https://t.co/qFGlgT7uyL (Twitter) - Feb 18, 2022
- ||| gedatolisib (PF-05212384) / Celcuity
Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Metastases: B2151009: A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer (clinicaltrials.gov) - Feb 15, 2022
P1b, N=141, Completed, Sponsor: Celcuity, Inc.
Further research should elucidate whether these inhibitors may be effective therapeutic agents in HNSCC patients. Active, not recruiting --> Completed | Trial completion date: Jun 2022 --> Jan 2022 | Trial primary completion date: Jun 2022 --> Jan 2022
- | sirolimus / Generic mfg.
Journal: Synthesis and bioevaluation of diaryl urea derivatives as potential antitumor agents for the treatment of human colorectal cancer. (Pubmed Central) - Feb 9, 2022
In this study, a series of diaryl urea derivatives has been designed and synthesized based on clinical candidate gedatolisib (6aa), and most of the newly synthesized derivatives showed kinase inhibitory and antiproliferative activities within nanomolar and submicromolar level, respectively...The safety investigations revealed that compound 6 ab exhibited more safer profiles in the selectivity of liver cells (selectivity index: >6.6 vs 1.85) and blood glucose regulation than 6aa. In addition, the in vitro stability assays also indicated our developed compound 6 ab possessed good metabolic stabilities.
- || Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
Enrollment closed, Trial completion date, Trial primary completion date: Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer (clinicaltrials.gov) - Feb 9, 2022
P1, N=18, Active, not recruiting, Sponsor: Hoffman Oncology
In addition, the in vitro stability assays also indicated our developed compound 6 ab possessed good metabolic stabilities. Recruiting --> Active, not recruiting | Trial completion date: Sep 2020 --> Mar 2022 | Trial primary completion date: Sep 2020 --> Feb 2022
- | gedatolisib (PF-05212384) / Celcuity
Journal: Antitumor activity of the dual PI3K/mTOR inhibitor gedatolisib and the involvement of ABCB1 in gedatolisib resistance in canine tumor cells. (Pubmed Central) - Feb 4, 2022
The mutations of E545K and H1047R in PIK3CA were not observed. The present results indicated that gedatolisib decreased cell viability in canine tumor cell lines and ABCB1 played an important role in gedatolisib resistance, supporting the potential use of gedatolisib for canine tumors.
- |||| gedatolisib (PF-05212384) / Celcuity
Fast track designation, FDA event: FDA grants fast track designation to gedatolisib for breast cancer subset https://t.co/XBkvfQnLOm (Twitter) - Jan 23, 2022
- || Talzenna (talazoparib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
Trial completion date, Trial primary completion date, Metastases: BTCRC-BRE18-337: Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers (clinicaltrials.gov) - Jan 20, 2022
P1/2, N=54, Recruiting, Sponsor: Kari Wisinski
The present results indicated that gedatolisib decreased cell viability in canine tumor cell lines and ABCB1 played an important role in gedatolisib resistance, supporting the potential use of gedatolisib for canine tumors. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
- || Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors (clinicaltrials.gov) - Jan 19, 2022
P1, N=96, Recruiting, Sponsor: Dana-Farber Cancer Institute
Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022 Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2022 --> Jan 2023
- || gedatolisib (PF-05212384) / Curie Institute, Pfizer
must note an additional downside: gedatolisib is an intravenous medication, so it ties one to an in-person visit 3/4 weeks (assuming that is the dosing that moves forward). #SABCS21 (Twitter) - Dec 10, 2021
- ||||| gedatolisib (PF-05212384) / Curie Institute, Pfizer
Clinical: Gedatolisib (pan PI3 and mTOR 1/2) Given w/ triplet ET+ CDK + gedatolisib ❓does schedule impact efficacy or is it small #? #SABCS21 #bcsm @OncoAlert (Twitter) - Dec 10, 2021
- | gedatolisib (PF-05212384) / Curie Institute, Pfizer
Journal: PKI-587 enhances radiosensitization of hepatocellular carcinoma by inhibiting the PI3K/AKT/mTOR pathways and DNA damage repair. (Pubmed Central) - Nov 29, 2021
These findings suggest the usefulness of PKI-587 on radiosensitization of HCC cells by inhibiting the PI3K/AKT/mTOR and DNA damage repair pathways. The combination of ionizing radiation and PKI-587 may be a strategy to improve the efficacy of treating HCC.
- |||||| gedatolisib (PF-05212384) / Celcuity
New trial: Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009 (clinicaltrials.gov) - Nov 25, 2021
P=N/A, N=0, Available, Sponsor: Celcuity, Inc.
- Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
Phase Ib expansion study of gedatolisib in combination with palbociclib and endocrine therapy in women with ER+ metastatic breast cancer (Stars at Night 1/2) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1520;
Responses were also observed in patients refractory to the last treatment. Therapy was well tolerated with manageable toxicity and low number of treatment discontinuation due to related AE.
- gedatolisib (PF-05212384) / Celcuity, Herzuma (trastuzumab biosimilar) / Nippon Kayaku, Mundipharma, Celltrion, Teva
Phase II study of trastuzumab biosimilar (Herzuma ® ) plus gedatolisib in patients with HER-2 positive metastatic breast cancer who progressed after 2 or more HER-2 directed chemotherapy (BR 18-13, KM-10A): Interim analysis (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_1423;
P2
Therapy was well tolerated with manageable toxicity and low number of treatment discontinuation due to related AE. In this phase 2 study, Trastuzumab biosimilar plus Gedatolisib presented 64.7% of response rate with manageable toxicity in patients with HER-2 positive MBC with PIK3CA mutation.
- || Talzenna (talazoparib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
Trial completion date, Trial primary completion date, Metastases: BTCRC-BRE18-337: Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers (clinicaltrials.gov) - Aug 19, 2021
P1/2, N=54, Recruiting, Sponsor: Kari Wisinski
In this phase 2 study, Trastuzumab biosimilar plus Gedatolisib presented 64.7% of response rate with manageable toxicity in patients with HER-2 positive MBC with PIK3CA mutation. Trial completion date: May 2022 --> Dec 2022 | Trial primary completion date: May 2021 --> Dec 2021
- ||||| gedatolisib (PF-05212384) / Curie Institute, Pfizer
Clinical, Combination therapy: Phase 1 Dose-Escalation Study of the dual PI3K-mTORC1/2 inhibitor Gedatolisib in combination with Paclitaxel and Carboplatin in Patients with Advanced Solid Tumors | Clinical Cancer Research https://t.co/YTg9l2yokx (Twitter) - Jul 17, 2021
- | paclitaxel / Generic mfg.
Journal, Checkpoint inhibition: Inhibition of the PI3K/mTOR Pathway in Breast Cancer to Enhance Response to Immune Checkpoint Inhibitors in Breast Cancer. (Pubmed Central) - Jul 4, 2021
Trial completion date: May 2022 --> Dec 2022 | Trial primary completion date: May 2021 --> Dec 2021 PI3K/mTOR inhibition plus PTX heightens response to ICI and may provide a viable therapeutic approach for treatment of metastatic BC.
- | gedatolisib (PF-05212384) / Curie Institute, Pfizer
Preclinical, Journal: Development of a Highly Specific Anti-drug Antibody Assay in Support of a Nanoparticle-based Therapeutic. (Pubmed Central) - Jun 10, 2021
To support the immunogenicity assessment of one of Pfizer's NP-based therapeutics, consisting of gedatolisib (GEDA) encapsulated in ACCURINS® (GEDA-NP), we developed an anti-GEDA-NP antibody (ADA) assay on the MSD platform for the detection of GEDA-NP induced ADA in human serum...The assay sensitivity was between 4.3 ng/mL and 123 ng/mL for surrogate positive controls of IgG and IgM isotypes, respectively. Additionally, assay interference from nonspecific matrix proteins and circulating drug was addressed, which ensured accurate assessment of ADA incidence that can be attributed to GEDA-NP.
- Piqray (alpelisib) / Novartis, Kisqali (ribociclib) / Novartis
[VIRTUAL] Preclinical evaluation of alpelisib (PI3K inhibitor) and its synergistic effect in combination with ribociclib (CDK 4/6 inhibitor) in colorectal cancer () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_438;
We will further investigate the combination of ribociclib and alpelisib in vivo in CRC animal models. The aim of this project is to justify a phase I clinical trial of ribociclib and alpelisib in CRC.
- [VIRTUAL] Fibroblast-induced paradoxical PI3K pathway activation in colorectal cancer: Role of PTEN and potential implications for PI3K/mTOR inhibition () - Jun 1, 2021 - Abstract #ESMOGI2021ESMO_GI_408;
Methods Sensitivity of cell lines to single (alpelisib, everolimus, MK-2206) and double PI3K/mTOR (gedatolisib and dactolisib) pathway inhibitors was investigated using Crystal Violet assay under differing culture conditions (wo FBS, in the presence of fibroblast-conditioned medium -CM- or in direct co-culture)...Results Based on results obtained in PTEN isogenic cell lines (HCT116 Parental and HCT116 PTEN-/-) under different culture conditions, we show that sensitivity to MEK inhibition (trametinib) is dictated mainly by the genetic background of the cancer cells; conversely, the effect of PI3K/mTOR double inhibition is profoundly influenced by exposure to fibroblast CM...Paradoxical PI3K activation involves the assembly and cellular relocalization of macromolecular complexes orchestrated by the PDZ domain of PTEN, resulting in activation of the mTORC1/p70S6K pathway. Therefore, TME-mediated pathway modulation could be potentially exploited to improve the treatment of PTEN-competent CRC patients and overcome therapeutic resistance to PI3K/mTOR inhibitor.
- | sirolimus / Generic mfg.
Journal: Design, synthesis and bioevaluation of novel substituted triazines as potential dual PI3K/mTOR inhibitors. (Pubmed Central) - May 22, 2021
A series of novel substituted triazines bearing a benzimidazole scaffold were designed and synthesized based on the structures of known anti-cancer agents, namely gedatolisib and alpelisib...Phosphoblot studies demonstrated that 19c and 19i could significantly suppress the PI3K/Akt/mTOR signaling pathway at 10 μM. Moreover, analogs 19b, 19c and 19i displayed better stability in artificial gastric fluids than gedatolisib, while 19i was indicated not very stable in rat liver microsomes, and may occur phase I metabolic transformations.
- [VIRTUAL] Sub-group of ovarian cancer patients with hyperactive RAS network signaling identified: Dynamic pathway activity test identifies patients that may benefit from PI3K/mTOR or PI3K/mTOR/BCL inhibitors () - Mar 11, 2021 - Abstract #AACR2021AACR_314;
These findings suggest that a significant sub-group of OC patients have a RAS-involved oncogenic driver that is responsive ex vivo to pan-PI3K/mTOR and pan-PI3K/mTOR/BCL inhibitors. A clinical trial to evaluate treatment response of this patient sub-group to combined PI3K/mTOR or PI3K/mTOR/BCL inhibitors is warranted.
- [VIRTUAL] Sub-group of HER2-negative breast cancer patients with hyperactive RAS network signaling identified: Dynamic pathway activity test identifies patients that may benefit from PI3K/mTOR or PI3K/mTOR/BCL inhibitors () - Mar 11, 2021 - Abstract #AACR2021AACR_290;
These findings suggest that a significant sub-group of BC patients have a RAS-involved oncogenic driver that is responsive ex vivo to pan-PI3K/mTOR and pan-PI3K/mTOR/BCL inhibitors. A clinical trial to evaluate treatment response of this patient sub-group to combined PI3K/mTOR or PI3K/mTOR/BCL inhibitors is warranted.
- | gedatolisib (PF-05212384) / Curie Institute, Pfizer
Journal: Oxaliplatin and Gedatolisib (PKI-587) Co-Loaded Hollow Polydopamine Nano-Shells with Simultaneous Upstream and Downstream Action to Re-Sensitize Drugs-Resistant Hepatocellular Carcinoma to Chemotherapy. (Pubmed Central) - Mar 4, 2021
We examined the intrinsic mechanisms of the combination therapy: O/PHP had excellent anti-cancer effects via the simultaneous upstream and downstream action to re-sensitize H cells to chemotherapy; OXA induced strong apoptosis via the direct platinum lesions on DNA molecules, while PKI-587 normalized the abnormally activated PI3K/AKT/mTOR signaling pathway and DNA damage repair pathway (NHEJ and HR) that could attenuate the effectiveness of OXA, thus resulting in inhibition of cell proliferation, migration and DNA repair enzyme activity and the augment of apoptotic effects. Such combination therapy, with simultaneous upstream and downstream action, may be a strategy for minimizing resistance for anti-cancer treatments.
- | gedatolisib (PF-05212384) / Celcuity, Herzuma (trastuzumab-pkrb) / Nippon Kayaku, Mundipharma, Celltrion, Teva
Enrollment open, Enrollment change, Metastases: KCSG-BR18-13: Phase II Study of Herzuma (clinicaltrials.gov) - Feb 18, 2021
P2, N=15, Recruiting, Sponsor: Korean Cancer Study Group
Such combination therapy, with simultaneous upstream and downstream action, may be a strategy for minimizing resistance for anti-cancer treatments. Not yet recruiting --> Recruiting | N=62 --> 15
- || gedatolisib (PF-05212384) / Curie Institute, Pfizer
Clinical, Journal: ABCB1 and ABCG2 restricts the efficacy of gedatolisib (PF-05212384), a PI3K inhibitor in colorectal cancer cells. (Pubmed Central) - Feb 18, 2021
Not yet recruiting --> Recruiting | N=62 --> 15 These findings suggest that overexpression of ABCB1 and ABCG2 may restrict the efficacy of gedatolisib in colorectal cancer cells, while co-administration with ABC transporter inhibitors may improve the potency of gedatolisib.
- || Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
Trial primary completion date, Combination therapy, Metastases: Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors (clinicaltrials.gov) - Jan 31, 2021
P1, N=96, Recruiting, Sponsor: Dana-Farber Cancer Institute
These findings suggest that overexpression of ABCB1 and ABCG2 may restrict the efficacy of gedatolisib in colorectal cancer cells, while co-administration with ABC transporter inhibitors may improve the potency of gedatolisib. Trial primary completion date: Jan 2021 --> Jan 2022
- | gedatolisib (PF-05212384) / Celcuity
Trial completion, Trial completion date, Trial primary completion date, Metastases: An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - Jan 7, 2021
P1, N=18, Completed, Sponsor: Kathy Miller
Trial primary completion date: Jan 2021 --> Jan 2022 Recruiting --> Completed | Trial completion date: Jun 2021 --> May 2020 | Trial primary completion date: Jan 2021 --> May 2020
- || gedatolisib (PF-05212384) / Celcuity
Enrollment closed, Combination therapy, Metastases: B2151009: A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer (clinicaltrials.gov) - Dec 23, 2020
P1b, N=141, Active, not recruiting, Sponsor: Pfizer
Recruiting --> Completed | Trial completion date: Jun 2021 --> May 2020 | Trial primary completion date: Jan 2021 --> May 2020 Recruiting --> Active, not recruiting
- | gedatolisib (PF-05212384) / Curie Institute, Pfizer, Vizimpro (dacomitinib) / Pfizer
Journal, Combination therapy: Dacomitinib and gedatolisib in combination with fractionated radiation in head and neck cancer. (Pubmed Central) - Dec 1, 2020
Our results showed that combining two drugs with radiation provided no added benefit compared to the single most active drug. Dacomitinib deserves more investigation as a radiation sensitizing agent in HNSCC.
- gedatolisib (PF-05212384) / Curie Institute, Pfizer, Herzuma (trastuzumab biosimilar) / Nippon Kayaku, Pfizer, Mundipharma, Celltrion, Teva
[VIRTUAL] Phase II pilot study of trastuzumab biosimilar (herzuma®) plus gedatolisib in patients with HER-2 positive metastatic breast cancer who progressed after 2 or more HER-2 directed chemotherapy [KM-10A/KCSG18-13 interim analysis] (OnDemand) - Nov 19, 2020 - Abstract #SABCS2020SABCS_1349;
P2
Clinical trial information: NCT03698383. This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health &Welfare, Republic of Korea (Grant number: HI17C2206).
- | PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Curie Institute, Pfizer
Preclinical, Journal: Evaluation of the dual mTOR/PI3K inhibitors Gedatolisib (PF-05212384) and PF-04691502 against ovarian cancer xenograft models. (Pubmed Central) - Nov 14, 2020
Both drugs produced apoptosis but minimally influenced markers of proliferation (Ki67, phospho-histone H3). These results indicate that mTOR/PI3K inhibition can produce broad spectrum tumour growth stasis in ovarian cancer xenograft models during continuous chronic treatment and this is associated with apoptosis.
- | Jevtana (cabazitaxel) / Sanofi
Journal: Novel nanococktail of a dual PI3K/mTOR inhibitor and cabazitaxel for castration-resistant prostate cancer. (Pubmed Central) - Oct 20, 2020
In an animal xenograft model, NanoGe showed superior efficacy than free Ge, and synergized with nanoformulated cabazitaxel (NanoCa) as a nanococktail format to achieve a cure rate of 83%. Taken together, our results demonstrate the potency of NanoGe in combination with NanoCa is potent against prostate cancer.
- | gedatolisib (PF-05212384) / Curie Institute, Pfizer
Journal: The Bioanalysis of Targeted Nanoparticles in Monkey Plasma via LC-MS/MS. (Pubmed Central) - Oct 7, 2020
This method leveraged automation to ease the burden of a laborious and complicated sample pretreatment and extraction pro-cedure. The automated method was used to support a preclinical safety study in monkeys in which both released and total PF 05212384 concentrations were determined in over 1600 monkey plasma study samples via LC MS/MS.
- cofetuzumab pelidotin (ABBV-647) / Pfizer, AbbVie, gedatolisib (PF-05212384) / Curie Institute, Pfizer
[VIRTUAL] An initial safety study of gedatolisib plus cofetuzumab pelidotin for metastatic triple-negative breast cancer (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_708;
P1
Further investigation of this drug combination in metastatic TNBC is warranted. Trial Registration: NCT03243331
- ||| gedatolisib (PF-05212384) / Celcuity
Trial completion, Combination therapy: A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC) (clinicaltrials.gov) - Aug 12, 2020
P1b, N=110, Completed, Sponsor: Pfizer
Trial Registration: NCT03243331 Recruiting --> Completed
- carboplatin / Generic mfg., paclitaxel / Generic mfg., gedatolisib (PF-05212384) / Curie Institute, Pfizer
[VIRTUAL] Phase I dose-escalation study of the dual PI3K/mTORC1/2 inhibitor Gedatolisib (PF-05212384) in combination with paclitaxel (P) and carboplatin (C) in patients (pts) with advanced solid tumours (On-Demand) - Jul 21, 2020 - Abstract #ESMO2020ESMO_849;
P1
Funding: Pfizer. Clinical trial identification: NCT02069158.
- || gedatolisib (PF-05212384) / Celcuity
Trial completion date, Trial primary completion date, Combination therapy, Metastases: B2151009: A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer (clinicaltrials.gov) - Jun 11, 2020
P1b, N=148, Recruiting, Sponsor: Pfizer
Clinical trial identification: NCT02069158. Trial completion date: Jun 2020 --> Jun 2022 | Trial primary completion date: Jun 2020 --> Jun 2022
- gedatolisib (PF-05212384) / Curie Institute, Pfizer
[VIRTUAL] Phase II study of gedatolisib for small-cell lung cancer (SCLC) patients (pts) with genetic alterations in PI3K/AKT/mTOR pathway based on a large-scale nationwide genomic screening network in Japan (EAGLE-PAT/LC-SCRUM-Japan). (Poster Board 257) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2333;
This phase II study didn’t show promising clinical benefit of gedatolisib for advanced SCLC pts with genetic alterations in the PI3K/AKT/mTOR pathway. The safety profile of gedatolisib was similar to that reported previously.
- Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Curie Institute, Pfizer
[VIRTUAL] Biomarker analysis from a phase I study using gedatolisib+palbociclib+hormone therapy in ER+/HER2- metastatic breast cancer (mBC). (Poster Board 137) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1777;
P1b
Somatic frequency changes of PI3K pathway alterations were most correlated with clinical response. Genomic data analysis from dose expansion samples is currently ongoing.