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PF-05212384

Phase 2

Neoplasm | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: Sep 13, 2022

PF-05212384 development status

Highest phase Phase 2 (NCT01420081)
Phase scored for PFEPhase 1
Registered trials 5 across 1 sponsor since May 2011

PF-05212384 target and mechanism

ModalitySmall molecule

Also known as PF-05212384 (also known as PKI-587), PF-05212384 (gedatolisib)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials2
Total Enrollment188

FDA Designations

No designations recorded

PF-05212384 clinical trials

PF-05212384 · 2 trials · 2 indications

Phase 1 2
NCT01920061A 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)Neoplasm
COMPLETED110 Analytics
NCT00940498Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid TumorsNeoplasms
COMPLETED78 Analytics
PHASE1COMPLETED
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)
NeoplasmUnlock trial analytics
PHASE1COMPLETED
Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Dose Limiting Toxicities (DLTs) - Arms A, B and C
Up to 21 days

DLT was defined as any of the following adverse events (AEs) attributable to the combination: (1) hematologic: grade 4 neutropenia lasting \>7 days; febrile neutropenia; grade \>=3 neutropenia with infection; grade 3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade \>=2 pneumonitis; grade\>=3 toxicities, except pneumonitis, and excluding those that had not been maximally treated; persistent, intolerable toxicities which resulted in the failure to deliver at least 3 of the 4 doses of PF-05212384 for Arms A and B or at least 3 of the 4 doses of PF-05212384 and 75% of dacomitinib for Arm C during the first cycle; the persistent, intolerable toxicities which result in delay of the start of the second cycle by more than 2 weeks relative to the scheduled start; in an asymptomatic participant, the grade 3 QTc prolongation persists after correction of any reversible causes.

Percentage of Participants With Objective Response - Arm B Expansion
Cycle 1 Day 1 up to 18 months

Percentage of participants with objective response based on the assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm) and no new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Baseline up to Cycle 14 (each cycle is 28 days)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Cycle 14, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)
Baseline up to Cycle 14 (each cycle is 28 days)

Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Cycle 14, that were absent before treatment or that worsened relative to pretreatment state. Relatedness to drug was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs included both serious and non-serious adverse events.

Number of Participants With Laboratory Abnormalities
Baseline up to Cycle 14 (each cycle is 28 days)

Criteria for laboratory test abnormality: hematology (hemoglobin \[less than {\<} 0.8\*lower limit of normal {LLN}\], platelets \[\<0.5\*LLN or greater than {\>} 1.75\*upper limit of normal {ULN}\], white blood cells \[\<0.6\*LLN or \>1.5\*ULN\], lymphocytes \[\<0.8\*LLN or \>1.2\*ULN\], total neutrophils \[\<0.8\*LLN or \>1.2\*ULN\], basophils, eosinophils, monocytes \[\>1.2\*ULN\]); coagulation \[partial thromboplastin time, prothrombin (PT), PT international ratio \[\>1.1\*ULN\]); liver function (total bilirubin \[\>1.5\*ULN\], aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase \[\>0.3\*ULN\], total protein, albumin \[\<0.8\*LLN or \>1.2\*ULN\]).

Number of Participants With Dose Limiting Toxicities (DLTs)
Baseline up to Day 28

DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: Grade 3 nonhematologic AE (including nausea, vomiting, or diarrhea despite optimal therapy; or greater than or equal to \[\>=\] grade 3 asthenia \>2 days; or fasting serum glucose \>250 milligrams per deciliter (mg/dL) despite optimal therapy); \>=Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade 4 neutropenia lasting more than 7 days; Febrile neutropenia; other Grade 4 hematologic AE; delay of treatment \>2 consecutive weeks due to toxicity. Grades were based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

Recommended Phase-2 Dose (RP2D)
Baseline up to Cycle 14 (each cycle is 28 days)

RP2D of PF-05212384 was determined based on the safety profile including laboratory and clinical assessments and pharmacodynamics findings.

Secondary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (All Causality) - Arms A, B, C and B Expansion
From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) - Arms A, B, C and B Expansion
From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
Arm CEXPERIMENTAL -
Expansion Arm 1EXPERIMENTAL -
Expansion Arm 2EXPERIMENTAL -
1EXPERIMENTALPF-05212384 (also known as PKI-587)

Interventions

NameTypeDescription
PF-05212384 (gedatolisib)DRUGPF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
DocetaxelDRUGDocetaxel intravenous infusions once every 3 weeks starting at 75 mg/m\^2
CisplatinDRUGCisplatin intravenous infusions once every 3 weeks starting at 75 mg/m\^2
DacomitinibDRUGDacomitinib to be taken orally as a continuous once daily regimen at a starting dose of 30 mg
PF-05212384 (also known as PKI-587)DRUGIntravenous dosing once weekly infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: Cisplatin Combination Expansion: Arm 1:Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting; Arm 2: Patients with TNBC and one or two prior cytotoxic therapies in the metastatic setting. * Arm A: castrate resistant prostate cancer, advanced...

Countries:United StatesCanadaItalySpainUnited Kingdom
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Frequently asked questions about PF-05212384

What is PF-05212384?

PF-05212384 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) for the treatment of neoplasm, or solid tumors, in oncology. It has been studied in Phase 1 clinical trials, both as a single agent and in combination with other anti-tumor agents, including cisplatin.

What is PF-05212384 used for?

PF-05212384 has been studied for the treatment of neoplasm, including triple negative breast cancer and solid tumors. It was evaluated in Phase 1 trials in adults with advanced disease, including an expansion arm combining it with other anti-tumor agents and with cisplatin in triple negative breast cancer.

Who makes PF-05212384?

PF-05212384 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 clinical studies of the compound in patients with solid tumors and triple negative breast cancer.

What phase is PF-05212384 in?

PF-05212384 is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies, and both have been completed. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is PF-05212384 in?

PF-05212384 has been studied in two completed Phase 1 trials. NCT01920061 evaluated PF-05212384 in combination with other anti-tumor agents and with cisplatin in triple negative breast cancer, enrolling 110 patients. NCT00940498 studied intravenous PF-05212384 in subjects with solid tumors, enrolling 78 patients.

Is PF-05212384 the same as PKI-587 or gedatolisib?

Yes. PF-05212384 is also known as PKI-587 and as gedatolisib. These names refer to the same investigational compound developed by Pfizer, Inc. for oncology indications, so search results using any of these names describe the same drug.