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- 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.
- | Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
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) - Apr 24, 2020
P1, N=18, Recruiting, Sponsor: Hoffman Oncology
Genomic data analysis from dose expansion samples is currently ongoing. Trial completion date: Mar 2020 --> Sep 2020 | Trial primary completion date: Jan 2020 --> Sep 2020
- || gedatolisib (PF-05212384) / Curie Institute, Pfizer
Clinical, Journal: Distribution, Metabolism, and Excretion of Gedatolisib in Healthy Male Volunteers After a Single Intravenous Infusion. (Pubmed Central) - Mar 24, 2020
P1
Metabolism of gedatolisib was trace; only 1 oxidative metabolite, M5, was identified in feces (<1% of total dose). Identification of gedatolisib in feces suggests that biliary and/or intestinal secretion of unchanged parent drug significantly contributes to gedatolisib clearance.
- | Journal: A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. (Pubmed Central) - Mar 4, 2020
We used the CellTiter-Glo viability assay to test library compounds against parental KB-3-1 human cervical adenocarcinoma cells and the colchicine-selected subline KB-8-5-11 that overexpresses P-gp...ABCG2 was also found to confer high levels of resistance to AT9283, GSK-690693, and gedatolisib, whereas ispinesib, AT7519, and KW-2478 were weaker substrates...Of the 10,804 compounds screened, a total of 90 substrates were identified of which 55 were novel. P-gp expression may adversely affect the oral bioavailability or brain penetration of these compounds.
- | mirdametinib (PD-0325901) / SpringWorks Therap, BeiGene, gedatolisib (PF-05212384) / Curie Institute, Pfizer
Journal: Combined inhibition of the PI3K/mTOR/MEK pathway induces Bim/Mcl-2-regulated apoptosis in pancreatic cancer cells. (Pubmed Central) - Feb 29, 2020
Moreover, a novel role was identified for PDCD4 loss in driving the apoptotic response to PF384/PD901 in BxPC3 and MIA-PaCa-2 cell lines. Overall, our data indicates PF384/PD901 co-treatment activates the same apoptotic mechanism in wild-type or KRAS mutant PDAC cells.
- gedatolisib (PF-05212384) / Curie Institute, Pfizer
Gedatolisib (STARLIGHT BALLROOM) - Feb 21, 2020 - Abstract #IASLCLCTT2020IASLC_LCTT_304;
- | gedatolisib (PF-05212384) / Celcuity
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) - Feb 17, 2020
P1, N=18, Recruiting, Sponsor: Kathy Miller
Overall, our data indicates PF384/PD901 co-treatment activates the same apoptotic mechanism in wild-type or KRAS mutant PDAC cells. Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jan 2020 --> Jan 2021
- MK-2206 / Merck (MSD), vistusertib (AZD2014) / AstraZeneca, gedatolisib (PF-05212384) / Curie Institute, Pfizer
Assessing the potential role of RICTOR expression as predictive factor of response to PI3K/mTOR pathway inhibitors in preclinical models of squamous cell lung cancer (Hall Bordeaux) - Feb 7, 2020 - Abstract #TAT2020TAT_58;
While CNG of RICTOR corresponded to increased protein expression, no correlation was observed with PI3K/mTOR pathway activity and drug sensitivity in vitro. We complemented this with genetic perturbation analyses, whose results aligned with pharmacological findings and suggest that Rictor does not represent a predictive biomarker of response towards PI3K/mTOR directed therapy.
- || 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) - Feb 7, 2020
P1, N=96, Recruiting, Sponsor: Dana-Farber Cancer Institute
We complemented this with genetic perturbation analyses, whose results aligned with pharmacological findings and suggest that Rictor does not represent a predictive biomarker of response towards PI3K/mTOR directed therapy. Trial primary completion date: Jan 2020 --> Jan 2021
- Preclinical drug testing for clinical trial planning of novel combinative therapy with PI3K and MAPK inhibitors in colorectal cancer(CRC). (Level 1, West Hall - Poster Board H21) - Dec 10, 2019 - Abstract #ASCOGI2020ASCO-GI_929;
P+G offers better alternative to P+PD since MEK inhibitor resistance had been associated with tumours harbouring KRAS with(out) PIK3CA mutations. BRAFV600E and ERBB2 mutations are useful negative predictors in this cohort.
- | gedatolisib (PF-05212384) / Celcuity
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER") (clinicaltrials.gov) - Nov 19, 2019
P1/2, N=0, Withdrawn, Sponsor: Abramson Cancer Center of the University of Pennsylvania
BRAFV600E and ERBB2 mutations are useful negative predictors in this cohort. N=104 --> 0 | Trial completion date: Dec 2023 --> Nov 2019 | Suspended --> Withdrawn | Trial primary completion date: Feb 2023 --> Aug 2019
- | gedatolisib (PF-05212384) / Celcuity
Trial suspension: Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER") (clinicaltrials.gov) - Oct 10, 2019
P1/2, N=104, Suspended, Sponsor: Abramson Cancer Center of the University of Pennsylvania
N=104 --> 0 | Trial completion date: Dec 2023 --> Nov 2019 | Suspended --> Withdrawn | Trial primary completion date: Feb 2023 --> Aug 2019 Recruiting --> Suspended
- | gedatolisib (PF-05212384) / Celcuity
Trial completion date, Trial termination, Metastases: Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) (clinicaltrials.gov) - Oct 3, 2019
P1/2, N=3, Terminated, Sponsor: University of Florida
Recruiting --> Suspended Trial completion date: Feb 2020 --> Apr 2019 | Active, not recruiting --> Terminated; Slow accrual
- Talzenna (talazoparib) / Pfizer, gedatolisib (PF-05212384) / Curie Institute, Pfizer
Phase 2 trial with safety-run in of gedatolisib plus talazoparib in advanced triple negative or BRCA1/2 positive HER2 negative breast cancer (Hall 1) - Sep 25, 2019 - Abstract #SABCS2019SABCS_692;
Cohort B will remain at 12 since it is exploratory. Contact information: The study is being administered through the Big Ten Cancer Research Consortium and can be identified as BTCRC-BRE18-337.
- | gedatolisib (PF-05212384) / Curie Institute, Pfizer
Journal: PKI-587 enhances chemosensitivity of oxaliplatin in hepatocellular carcinoma through suppressing DNA damage repair pathway (NHEJ and HR) and PI3K/AKT/mTOR pathway. (Pubmed Central) - Sep 10, 2019
We conclude that PKI-587 enhances chemosensitivity of oxaliplatin in HCC through suppressing the PI3K/AKT/mTOR signalling pathway and inhibiting the DNA damage repair pathway. The combination of PKI-587 and oxaliplatin appears to be a promising regimen for the treatment of HCC.
- | gedatolisib (PF-05212384) / Celcuity
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) - Aug 6, 2019
P1, N=18, Recruiting, Sponsor: Kathy Miller
The combination of PKI-587 and oxaliplatin appears to be a promising regimen for the treatment of HCC. Trial completion date: Jan 2020 --> Jun 2020 | Trial primary completion date: Aug 2019 --> Jan 2020
- | gedatolisib (PF-05212384) / Curie Institute, Pfizer
Journal: Acute leukemia cells resistant to PI3K/mTOR inhibition display upregulation of P2RY14 expression. (Pubmed Central) - Jul 11, 2019
...We observed that while a number of cell lines displayed sensitivity to the dual PI3K/mTOR pathway inhibitor PKI-587, many cells displayed substantial resistance...We observed that activation of P2RY14 by its ligand, UDP-glucose, resulted in selective induction of ERK1/2 phosphorylation. Taken together, our data suggest that acute leukemia cells resistant to PI3K/mTOR inhibition display upregulation of a GPCR, P2RY14, which has a role in patient survival and also couples to the activation of ERK signaling.
- | Talzenna (talazoparib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
Enrollment open, Metastases: BTCRC-BRE18-337: Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers (clinicaltrials.gov) - Jul 9, 2019
P1/2, N=54, Recruiting, Sponsor: Kari Wisinski
Taken together, our data suggest that acute leukemia cells resistant to PI3K/mTOR inhibition display upregulation of a GPCR, P2RY14, which has a role in patient survival and also couples to the activation of ERK signaling. Not yet recruiting --> Recruiting
- | gedatolisib (PF-05212384) / Celcuity
Trial completion, Trial completion date, Trial primary completion date, Metastases: IOSI-NDU-001: Dose Finding Study Of PF-05212384 With Paclitaxel And Carboplatin In Patients With Advanced Solid Tumor (clinicaltrials.gov) - May 21, 2019
P1, N=17, Completed, Sponsor: Cristiana Sessa
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> May 2019 | Trial primary completion date: Dec 2019 --> May 2019
- | gedatolisib (PF-05212384) / Curie Institute, Pfizer
Biomarker, Journal: Metabolic determinants of sensitivity to phosphatidylinositol 3-kinase pathway inhibitor in small-cell lung carcinoma. (Pubmed Central) - May 18, 2019
...Here, we show that metabolic features determine sensitivity to the PI3K/mTOR dual inhibitor gedatolisib in SCLC cells...These results indicate that the resistance mechanism of PI3K pathway inhibitors is mediated by the activation of the purine salvage pathway, supplying purine resource to nucleotide biosynthesis. Metabolomics is a powerful approach for finding novel therapeutic biomarkers in SCLC treatment.
- |||| Talzenna (talazoparib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
New P1/2 trial, Metastases: BTCRC-BRE18-337: Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers (clinicaltrials.gov) - Apr 10, 2019
P1/2, N=54, Not yet recruiting, Sponsor: Kari Wisinski
- | gedatolisib (PF-05212384) / Curie Institute, Pfizer
Journal: Activation of WNT/β-catenin signaling results in resistance to a dual PI3K/mTOR inhibitor in colorectal cancer cells harboring PIK3CA mutations. (Pubmed Central) - Apr 7, 2019
Co-treatment with GSK3? inhibitors may be a strategy to overcome the resistance of PIK3CA- and TCF7-mutant CRC to PI3K/mTOR-targeted therapies.
- ||| gedatolisib (PF-05212384) / Celcuity
Enrollment open: Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER") (clinicaltrials.gov) - Mar 29, 2019
P1/2, N=104, Recruiting, Sponsor: Abramson Cancer Center of the University of Pennsylvania
inhibitors may be a strategy to overcome the resistance of PIK3CA- and TCF7-mutant CRC to PI3K/mTOR-targeted therapies. Not yet recruiting --> Recruiting
- || 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) - Feb 25, 2019
P1b, N=148, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting Trial completion date: Oct 2019 --> Jun 2020 | Trial primary completion date: Oct 2019 --> Jun 2020
- | Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
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 21, 2019
P1, N=18, Recruiting, Sponsor: Hoffman Oncology
Trial completion date: Oct 2019 --> Jun 2020 | Trial primary completion date: Oct 2019 --> Jun 2020 Trial completion date: Mar 2019 --> Mar 2020 | Trial primary completion date: Jan 2019 --> Jan 2020
- | gedatolisib (PF-05212384) / Celcuity
Trial termination: LAM-PIK: PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Feb 6, 2019
P2, N=10, Terminated, Sponsor: Institut Curie
Active, not recruiting --> Terminated; No objective response was observed at the first step. The treatment was considered ineffective, with a complete clinical trial suspension.
- ||| gedatolisib (PF-05212384) / Celcuity
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases: Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) (clinicaltrials.gov) - Jan 22, 2019
P1/2, N=2, Active, not recruiting, Sponsor: University of Florida
The treatment was considered ineffective, with a complete clinical trial suspension. Recruiting --> Active, not recruiting | N=51 --> 2 | Trial completion date: Sep 2022 --> Feb 2020 | Trial primary completion date: Sep 2020 --> Jan 2019
- ||| gedatolisib (PF-05212384) / Celcuity
Enrollment change: Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER") (clinicaltrials.gov) - Jan 10, 2019
P1/2, N=104, Not yet recruiting, Sponsor: Abramson Cancer Center of the University of Pennsylvania
Recruiting --> Active, not recruiting | N=51 --> 2 | Trial completion date: Sep 2022 --> Feb 2020 | Trial primary completion date: Sep 2020 --> Jan 2019 N=80 --> 104
- || gedatolisib (PF-05212384) / Celcuity
Trial completion date, Trial primary completion date, 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) - Dec 26, 2018
P1b, N=124, Recruiting, Sponsor: Pfizer
N=80 --> 104 Trial completion date: Jan 2019 --> Oct 2019 | Trial primary completion date: Jan 2019 --> Oct 2019
- || gedatolisib (PF-05212384) / Celcuity
Trial completion date, Trial initiation date, Trial primary completion date: Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER") (clinicaltrials.gov) - Dec 19, 2018
P1/2, N=80, Not yet recruiting, Sponsor: Abramson Cancer Center of the University of Pennsylvania
Trial completion date: Jan 2019 --> Oct 2019 | Trial primary completion date: Jan 2019 --> Oct 2019 Trial completion date: Dec 2022 --> Dec 2023 | Initiation date: Feb 2018 --> Feb 2019 | Trial primary completion date: Feb 2022 --> Feb 2023
- | gedatolisib (PF-05212384) / Celcuity
Enrollment closed, Enrollment change, Metastases: IOSI-NDU-001: Dose Finding Study Of PF-05212384 With Paclitaxel And Carboplatin In Patients With Advanced Solid Tumor (clinicaltrials.gov) - Nov 28, 2018
P1, N=17, Active, not recruiting, Sponsor: Cristiana Sessa
Trial completion date: Dec 2022 --> Dec 2023 | Initiation date: Feb 2018 --> Feb 2019 | Trial primary completion date: Feb 2022 --> Feb 2023 Recruiting --> Active, not recruiting | N=40 --> 17
- | gedatolisib (PF-05212384) / Celcuity
Enrollment open, 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) - Nov 16, 2018
P1b, N=124, Recruiting, Sponsor: Pfizer
Recruiting --> Active, not recruiting | N=40 --> 17 Active, not recruiting --> Recruiting
- || gedatolisib (PF-05212384) / Celcuity
Enrollment closed, 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) - Nov 9, 2018
P1b, N=110, Active, not recruiting, Sponsor: Pfizer
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
- | gedatolisib (PF-05212384) / Celcuity, Herzuma (trastuzumab-pkrb) / Nippon Kayaku, Mundipharma, Celltrion, Teva
New P2 trial, Metastases: KCSG-BR18-13: Phase II Study of Herzuma (clinicaltrials.gov) - Oct 9, 2018
P2, N=62, Not yet recruiting, Sponsor: Korean Cancer Study Group
- | mirdametinib (PD-0325901) / SpringWorks Therap, BeiGene, PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Curie Institute, Pfizer
P1 data, Journal: A Multi-Arm Phase I Study of the PI3K/mTOR Inhibitors PF-04691502 and Gedatolisib (PF-05212384) plus Irinotecan or the MEK Inhibitor PD-0325901 in Advanced Cancer. (Pubmed Central) - Aug 4, 2018
P1
Recruiting --> Active, not recruiting Further evaluations of gedatolisib are warranted in patients with advanced solid malignancies.
- | PI-103 / Roche, sirolimus / Generic mfg., gedatolisib (PF-05212384) / Curie Institute, Pfizer
Preclinical, Journal: Evidence of the Immunomodulatory Role of Dual PI3K/mTOR Inhibitors in graft survival. (Pubmed Central) - Jun 18, 2018
Similar to Rapamycin, in vivo administration of PI-103 and PKI-587 controlled effectively the immunological response against allogenic skin graft. These results characterize specific regulatory mechanisms of dual PI3K/mTOR inhibitors in T-cells and support their potential as a novel therapeutic option in transplantation.
- | Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
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) - Jun 12, 2018
P1, N=18, Recruiting, Sponsor: Hoffman Oncology
These results characterize specific regulatory mechanisms of dual PI3K/mTOR inhibitors in T-cells and support their potential as a novel therapeutic option in transplantation. Trial completion date: Mar 2018 --> Mar 2019 | Trial primary completion date: Jan 2018 --> Jan 2019
- | gedatolisib (PF-05212384) / Celcuity
Trial primary completion date, Metastases: IOSI-NDU-001: Dose Finding Study Of PF-05212384 With Paclitaxel And Carboplatin In Patients With Advanced Solid Tumor (clinicaltrials.gov) - Apr 5, 2018
P1, N=40, Recruiting, Sponsor: Cristiana Sessa
Trial completion date: Mar 2018 --> Mar 2019 | Trial primary completion date: Jan 2018 --> Jan 2019 Trial primary completion date: Dec 2017 --> Dec 2019
- || gedatolisib (PF-05212384) / Celcuity
Trial completion date, Trial primary completion date, 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) - Mar 30, 2018
P1b, N=124, Recruiting, Sponsor: Pfizer
Trial primary completion date: Dec 2017 --> Dec 2019 Trial completion date: Dec 2019 --> Jan 2019 | Trial primary completion date: Dec 2019 --> Jan 2019
- |||| gedatolisib (PF-05212384) / Celcuity
Enrollment open, Metastases: Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) (clinicaltrials.gov) - Mar 13, 2018
P1/2, N=51, Recruiting, Sponsor: University of Florida
Trial completion date: Dec 2019 --> Jan 2019 | Trial primary completion date: Dec 2019 --> Jan 2019 Suspended --> Recruiting
- | gedatolisib (PF-05212384) / Celcuity
Enrollment open, Trial initiation date, Metastases: An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - Feb 12, 2018
P1, N=18, Recruiting, Sponsor: Kathy Miller
Suspended --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Sep 2017 --> Jan 2018
- | gedatolisib (PF-05212384) / Celcuity
New P1/2 trial: Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER") (clinicaltrials.gov) - Jan 17, 2018
P1/2, N=80, Not yet recruiting, Sponsor: Abramson Cancer Center of the University of Pennsylvania
- | PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Celcuity
New P2 trial: A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer (clinicaltrials.gov) - Dec 29, 2017
P2, N=67, Terminated, Sponsor: Pfizer
- | gedatolisib (PF-05212384) / Celcuity
New P1/2 trial, Metastases: Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) (clinicaltrials.gov) - Dec 19, 2017
P1/2, N=51, Suspended, Sponsor: University of Florida
- | gedatolisib (PF-05212384) / Celcuity
Enrollment change, Metastases: Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) (clinicaltrials.gov) - Dec 18, 2017
P1/2, N=51, Suspended, Sponsor: University of Florida
Not yet recruiting --> Recruiting | Initiation date: Sep 2017 --> Jan 2018 N=41 --> 51
- | gedatolisib (PF-05212384) / Celcuity
Trial suspension, Metastases: Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) (clinicaltrials.gov) - Nov 27, 2017
P1/2, N=41, Suspended, Sponsor: University of Florida
N=41 --> 51 Recruiting --> Suspended
- | gedatolisib (PF-05212384) / Celcuity
Trial primary completion date: LAM-PIK: PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Aug 28, 2017
P2, N=10, Active, not recruiting, Sponsor: Institut Curie
Recruiting --> Suspended Trial primary completion date: Oct 2017 --> May 2017