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- ||| Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
Enrollment open, 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) - Mar 28, 2017
P1, N=96, Recruiting, Sponsor: Dana-Farber Cancer Institute
Not yet recruiting --> Recruiting
- | 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) - Mar 27, 2017
P1, N=40, Recruiting, Sponsor: Cristiana Sessa
Not yet recruiting --> Recruiting Trial primary completion date: Jun 2017 --> Dec 2017
- || gedatolisib (PF-05212384) / Celcuity
Enrollment change, 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 8, 2017
P1b, N=124, Recruiting, Sponsor: Pfizer
Trial primary completion date: Jun 2017 --> Dec 2017 N=94 --> 124
- ||| Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
New P1 trial, 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 27, 2017
P1, N=96, Not yet recruiting, Sponsor: Dana-Farber Cancer Institute
- || gedatolisib (PF-05212384) / Celcuity
Trial initiation 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 24, 2017
P1b, N=120, Recruiting, Sponsor: Pfizer
N=94 --> 124 Initiation date: Dec 2015 --> Jun 2016 | Trial primary completion date: May 2019 --> Sep 2019
- gedatolisib (PF-05212384) / Celcuity
Enrollment closed, Enrollment change, Trial initiation date: LAM-PIK: PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Feb 3, 2017
P2, N=10, Active, not recruiting, Sponsor: Institut Curie
Initiation date: Dec 2015 --> Jun 2016 | Trial primary completion date: May 2019 --> Sep 2019 Recruiting --> Active, not recruiting | N=39 --> 10 | Initiation date: Jun 2015 --> Aug 2015
- || gedatolisib (PF-05212384) / Celcuity
Trial initiation 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) - Jan 31, 2017
P1b, N=120, Recruiting, Sponsor: Pfizer
Recruiting --> Active, not recruiting | N=39 --> 10 | Initiation date: Jun 2015 --> Aug 2015 Initiation date: Jun 2016 --> Dec 2015
- | gedatolisib (PF-05212384) / Celcuity
Metastases: Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) (clinicaltrials.gov) - Sep 29, 2016
P1/2, N=41, Not yet recruiting, Sponsor: University of Florida
- 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) - Sep 8, 2016
P1, N=40, Recruiting, Sponsor: Cristiana Sessa
Initiation date: Jun 2016 --> Dec 2015 Trial primary completion date: Dec 2016 --> Jun 2017
- ||| gedatolisib (PF-05212384) / Celcuity
Enrollment open, 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) - Jul 12, 2016
P1b, N=121, Recruiting, Sponsor: Pfizer
Trial primary completion date: Dec 2016 --> Jun 2017 Not yet recruiting --> Recruiting
- gedatolisib (PF-05212384) / Celcuity
Enrollment open: LAM-PIK: PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Jul 11, 2016
P2, N=39, Recruiting, Sponsor: Institut Curie
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | gedatolisib (PF-05212384) / Celcuity
Phase classification, 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, 2016
P1b, N=121, Not yet recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting Phase classification: P1 --> P1b
- | gedatolisib (PF-05212384) / Celcuity
Phase classification, 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) - Jun 5, 2016
P1b, N=94, Recruiting, Sponsor: Pfizer
Phase classification: P1 --> P1b Phase classification: P1 --> P1b
- Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
Enrollment open: Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer (clinicaltrials.gov) - May 4, 2016
P1, N=18, Recruiting, Sponsor: Eastchester Center for Cancer Care
Phase classification: P1 --> P1b Not yet recruiting --> Recruiting
- || gedatolisib (PF-05212384) / Celcuity
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) - Apr 15, 2016
P1, N=94, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting Trial primary completion date: Jan 2017 --> Dec 2018
- ||| gedatolisib (PF-05212384) / Celcuity
New P1 trial, 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 17, 2016
P1, N=121, Not yet recruiting, Sponsor: Pfizer
- PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Celcuity
Enrollment change, Combination therapy, Metastases: Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer (clinicaltrials.gov) - Jan 15, 2016
P1, N=105, Terminated, Sponsor: Pfizer
Trial primary completion date: Jan 2017 --> Dec 2018 N=165 --> 105
- Ibrance (palbociclib) / Pfizer, gedatolisib (PF-05212384) / Celcuity
New P1 trial: Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer (clinicaltrials.gov) - Dec 10, 2015
P1, N=18, Not yet recruiting, Sponsor: Eastchester Center for Cancer Care
- gedatolisib (PF-05212384) / Celcuity
Trial primary completion date, Metastases: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer (clinicaltrials.gov) - Dec 5, 2015
P2, N=150, Terminated, Sponsor: Pfizer
N=165 --> 105 Trial primary completion date: Nov 2015 --> May 2016
- || gedatolisib (PF-05212384) / Celcuity
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) - Nov 24, 2015
P1, N=94, Recruiting, Sponsor: Pfizer
Trial primary completion date: Nov 2015 --> May 2016 Trial primary completion date: May 2016 --> Jan 2017
- || gedatolisib (PF-05212384) / Celcuity
Enrollment change, 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 6, 2015
P1, N=94, Recruiting, Sponsor: Pfizer
Trial primary completion date: May 2016 --> Jan 2017 N=130 --> 94
- gedatolisib (PF-05212384) / Celcuity
Trial termination, Metastases: A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer (clinicaltrials.gov) - Oct 22, 2015
P2, N=18, Terminated, Sponsor: Pfizer
N=130 --> 94 Completed --> Terminated; B2151007 was prematurely discontinued due to Pfizer's change in prioritization for the portfolio and is not due to any safety concerns or regulatory interaction
- 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) - Sep 24, 2015
P1, N=40, Recruiting, Sponsor: Cristiana Sessa
Completed --> Terminated; B2151007 was prematurely discontinued due to Pfizer's change in prioritization for the portfolio and is not due to any safety concerns or regulatory interaction Trial primary completion date: Feb 2016 --> Dec 2016
- gedatolisib (PF-05212384) / Celcuity
Enrollment change, Trial primary completion date, Metastases: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer (clinicaltrials.gov) - Sep 22, 2015
P2, N=150, Terminated, Sponsor: Pfizer
Trial primary completion date: Feb 2016 --> Dec 2016 N=19 --> 150 | Trial primary completion date: Aug 2015 --> Nov 2015
- | gedatolisib (PF-05212384) / Celcuity
Trial completion, Enrollment change, Metastases: A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer (clinicaltrials.gov) - Aug 19, 2015
P2, N=18, Completed, Sponsor: Pfizer
N=19 --> 150 | Trial primary completion date: Aug 2015 --> Nov 2015 Active, not recruiting --> Completed | N=190 --> 18
- ||| gedatolisib (PF-05212384) / Celcuity
Enrollment closed, Metastases: A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer (clinicaltrials.gov) - Aug 11, 2015
P2, N=190, Active, not recruiting, Sponsor: Pfizer
Active, not recruiting --> Completed | N=190 --> 18 Recruiting --> Active, not recruiting
- || gedatolisib (PF-05212384) / Celcuity
Trial primary completion date, Metastases: A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer (clinicaltrials.gov) - Jun 25, 2015
P2, N=190, Recruiting, Sponsor: Pfizer
Recruiting --> Active, not recruiting Trial primary completion date: Mar 2017 --> Mar 2016
- || gedatolisib (PF-05212384) / Celcuity
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) - Jun 11, 2015
P1, N=130, Recruiting, Sponsor: Pfizer
Trial primary completion date: Mar 2017 --> Mar 2016 Trial primary completion date: Jan 2016 --> May 2016
- gedatolisib (PF-05212384) / Celcuity
Enrollment change, Metastases: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer (clinicaltrials.gov) - Jun 11, 2015
P2, N=19, Terminated, Sponsor: Pfizer
Trial primary completion date: Jan 2016 --> May 2016 N=150 --> 19
- gedatolisib (PF-05212384) / Celcuity
New P2 trial: LAM-PIK: PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - May 8, 2015
P2, N=39, Not yet recruiting, Sponsor: Institut Curie
- gedatolisib (PF-05212384) / Celcuity
Enrollment change, Metastases: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer (clinicaltrials.gov) - May 5, 2015
P2, N=150, Terminated, Sponsor: Pfizer
N=150 --> 19 N=17 --> 150
- PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Celcuity
Trial termination, Trial primary completion date, Combination therapy, Metastases: Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer (clinicaltrials.gov) - Apr 21, 2015
P1, N=165, Terminated, Sponsor: Pfizer
N=17 --> 150 Recruiting --> Terminated | Trial primary completion date: Jul 2016 --> Oct 2015; Refer to Detailed Description for documentaion of Termination Statement.
- || PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Celcuity
Enrollment change, Combination therapy, Metastases: Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer (clinicaltrials.gov) - Mar 12, 2015
P1, N=165, Recruiting, Sponsor: Pfizer
Recruiting --> Terminated | Trial primary completion date: Jul 2016 --> Oct 2015; Refer to Detailed Description for documentaion of Termination Statement. N=120 --> 165
- PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Celcuity
Enrollment change, Trial initiation date: A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer (clinicaltrials.gov) - Feb 13, 2015
P2, N=67, Terminated, Sponsor: Pfizer
N=120 --> 165 N=160 --> 67 | Initiation date: Oct 2011 --> Jan 2012
- gedatolisib (PF-05212384) / Celcuity
Enrollment change, Metastases: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer (clinicaltrials.gov) - Feb 6, 2015
P2, N=150, Terminated, Sponsor: Pfizer
N=160 --> 67 | Initiation date: Oct 2011 --> Jan 2012 N=15 --> 150
- || gedatolisib (PF-05212384) / Celcuity
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) - Feb 5, 2015
P1, N=130, Recruiting, Sponsor: Pfizer
N=15 --> 150 Trial primary completion date: Aug 2015 --> Jan 2016
- || PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Celcuity
Trial primary completion date, Combination therapy, Metastases: Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer (clinicaltrials.gov) - Dec 24, 2014
P1, N=120, Recruiting, Sponsor: Pfizer
Trial primary completion date: Aug 2015 --> Jan 2016 Trial primary completion date: Jun 2015 --> Jul 2016
- PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Celcuity
Enrollment change: A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer (clinicaltrials.gov) - Dec 19, 2014
P2, N=160, Terminated, Sponsor: Pfizer
Trial primary completion date: Jun 2015 --> Jul 2016 N=67 --> 160
- gedatolisib (PF-05212384) / Celcuity
Enrollment change, Trial termination, Metastases: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer (clinicaltrials.gov) - Dec 17, 2014
P2, N=15, Terminated, Sponsor: Pfizer
N=150 --> 15 | Recruiting --> Terminated; Enrollment to the study was terminated on 11Nvo2014 due to slow recruitment. There were no safety or efficacy issues that contributed to this decision.
- PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Celcuity
Enrollment change: A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer (clinicaltrials.gov) - Nov 18, 2014
P2, N=67, Terminated, Sponsor: Pfizer
There were no safety or efficacy issues that contributed to this decision. N=160 --> 67
- || gedatolisib (PF-05212384) / Celcuity
Phase classification, Enrollment change, 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 11, 2014
P1, N=130, Recruiting, Sponsor: Pfizer
N=160 --> 67 Phase classification: P1b --> P1 | N=85 --> 130
- || PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Celcuity
Trial primary completion date, Combination therapy, Metastases: Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer (clinicaltrials.gov) - Oct 31, 2014
P1, N=120, Recruiting, Sponsor: Pfizer
Phase classification: P1b --> P1 | N=85 --> 130 Trial primary completion date: Sep 2014 --> Jun 2015
- PF-04691502 / Pfizer, gedatolisib (PF-05212384) / Celcuity
Enrollment change, Trial initiation date: A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer (clinicaltrials.gov) - Oct 31, 2014
P2, N=160, Terminated, Sponsor: Pfizer
Trial primary completion date: Sep 2014 --> Jun 2015 N=67 --> 160 | Initiation date: Jan 2012 --> Oct 2011
- | gedatolisib (PF-05212384) / Celcuity
Phase classification, Metastases: A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer (clinicaltrials.gov) - Oct 30, 2014
P2, N=185, Recruiting, Sponsor: Pfizer
N=67 --> 160 | Initiation date: Jan 2012 --> Oct 2011 Phase classification: P1/2 --> P2
- || gedatolisib (PF-05212384) / Celcuity
Trial primary completion date, Metastases: A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer (clinicaltrials.gov) - Sep 10, 2014
P1/2, N=180, Recruiting, Sponsor: Pfizer
Phase classification: P1/2 --> P2 Trial primary completion date: Sep 2016 --> Mar 2017
- || gedatolisib (PF-05212384) / Celcuity
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) - Sep 10, 2014
P1b, N=85, Recruiting, Sponsor: Pfizer
Trial primary completion date: Sep 2016 --> Mar 2017 Trial primary completion date: Feb 2015 --> Aug 2015
- gedatolisib (PF-05212384) / Celcuity
Trial completion: Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers (clinicaltrials.gov) - Aug 28, 2014
P1, N=6, Completed, Sponsor: Pfizer
Trial primary completion date: Feb 2015 --> Aug 2015 Active, not recruiting --> Completed
- ||| gedatolisib (PF-05212384) / Celcuity
Trial initiation date, Metastases: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer (clinicaltrials.gov) - Aug 11, 2014
P2, N=159, Recruiting, Sponsor: Pfizer
Active, not recruiting --> Completed Initiation date: Apr 2014 --> Nov 2013
- gedatolisib (PF-05212384) / Celcuity
Enrollment closed: Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers (clinicaltrials.gov) - Aug 4, 2014
P1, N=6, Active, not recruiting, Sponsor: Pfizer
Initiation date: Apr 2014 --> Nov 2013 Not yet recruiting --> Active, not recruiting
- ||| gedatolisib (PF-05212384) / Celcuity
Trial initiation date, Metastases: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer (clinicaltrials.gov) - Jul 14, 2014
P2, N=159, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Active, not recruiting Initiation date: Nov 2013 --> Apr 2014