Pancreatic Cancer Research

Clinical trialPhase 2Terminated

Ph1b/2 Study of PF-04136309 in Combination With Gem/Nab-P in First-line Metastatic Pancreatic Patients

PHASE 1B/2 STUDY OF PF-04136309 IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA

NCT02732938↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Stopped earlyPfizer made a business-related decision on 04May2017 to terminate study based on change in portfolio prioritization, and is not due to safety or efficacy. (Business decision)
Phase
Phase 2
Status
Terminated
Study type
Interventional
Start
4 May 2016
Expected end
10 October 2017
Enrollment
22 participants
Sites
18
Primary outcomes
Number of Participants With Dose-Limiting Toxicities (DLTs) [Phase 1b]; Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Phase 1b]; Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity [Phase 1b]; Number of Participants With Hematology Laboratory Abnormalities by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Phase 1b]; Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b]
Sponsor
Industry
Results posted
2019-02-04
Last update
4 February 2019

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Brief summary public domain (ClinicalTrials.gov)

The purpose of this Phase 1b/2 study is to evaluate the safety and tolerability of PF-04136309 in combination with nab-paclitaxel and gemcitabine, characterize the dose-limiting toxicities (DLTs) and overall safety profile of escalated doses of PF-04136309 and the associated schedule, determine the maximum tolerated dose (MTD), and to assess the enhancement of efficacy of PF-04136309 in combination with nab-paclitaxel and gemcitabine versus nab-paclitaxel + gemcitabine + placebo in terms of Progression Free Survival.

Detailed description public domain (ClinicalTrials.gov)

The study has 2 parts: Phase 1b (dose-finding cohorts) will be open label as patients will receive ascending doses of PF-04136309 in combination with nab-paclitaxel + gemcitabine. The observation period for dose-limiting toxicities (DLTs) will be from Day 1 to Day 28. Pharmacokinetic (PK) and pharmacodynamic (PD) properties of PF-04136309 will also be assessed. The criteria for dose escalation will be based on a modified toxicity probability interval (mTPI) method. After evaluating the safety and other results (eg, PK) from patients enrolled in the dose escalation cohorts, a dose level will be selected to be further evaluated as the Recommended Phase 2 Dose (RP2D). A minimum of 6 patients, up to 12 patients, will be treated at this dose level to establish it as the RP2D. To further evaluate safety and pharmacodynamics, the number of patients enrolled during this part of the study (Phase 1b) may be N up to 20. The study will stop if all PF-04136309 doses explored appear to be overly toxic. Phase 2 randomized double blinded placebo control. Approximately 92 patients will be randomized 1:1 to receive the RP2D of PF-04136309 in combination with nab-paclitaxel + gemcitabine (ARM A; n=46) versus nab-paclitaxel + gemcitabine + placebo (ARM B; n=46). The primary objective will be the enhancement of efficacy in terms of PFS. Patients will be treated as long as they are clinically benefiting from investigational product without unacceptable toxicity, objective disease progression, or withdrawal of consent.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Dose-Limiting Toxicities (DLTs) [Phase 1b] [Day 1 to Day 28]. Count Of Participants, Participants. Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 1; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 3.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Phase 1b] [1 year]. Count Of Participants, Participants. Treatment-emergent AE (all causality): Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 4; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 17. Treatment-emergent AE (PF-04136309 related): Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 3; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 16. Treatment-emergent SAE (all causality): Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 3; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 11. Treatment-emergent SAE (PF-04136309 related): Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 2; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 4.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity [Phase 1b] [1 year]. Count Of Participants, Participants. Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 0. Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 1. Grade 3: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 4; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 12. Grade 4: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 3. Grade 5: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 1.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Hematology Laboratory Abnormalities by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Phase 1b] [1 year]. Count Of Participants, Participants. Anemia, Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 1; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 5. Anemia, Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 3; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 8. Anemia, Grade 3: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 4. Lymphocyte count increased, Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 1. Lymphopenia, Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 1; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 3. Lymphopenia, Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 2; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 3. Lymphopenia, Grade 3: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 1; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 8. Neutrophils (absolute), Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 1. Neutrophils (absolute), Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 5. Neutrophils (absolute), Grade 3: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 3; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 2. Neutrophils (absolute), Grade 4: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 1. Platelets, Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 3; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 10. Platelets, Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 1; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 2. WBC, Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 2. WBC, Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 5. WBC, Grade 3: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 3; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 2. WBC, Grade 4: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Ph

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b] [1 year]. Count Of Participants, Participants. ALT, Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 1; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 8. ALT, Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 2; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 3. ALT, Grade 3: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 1; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 4. ALT, Grade 4: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 1. Alkaline phosphatase, Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 2; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 7. Alkaline phosphatase, Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 1; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 5. Alkaline phosphatase, Grade 3: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 2. AST, Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 2; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 8. AST, Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 1; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 1. AST, Grade 3: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 1; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 5. Bilirubin (total), Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 1. Bilirubin (total), Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 3. Bilirubin (total), Grade 3: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 2. Creatinine, Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 4; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 9. Creatinine, Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 0; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 2. GGT, Grade 1: Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 1. Hyperglycemia, Grade 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 2; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=17): 6. Hyperglycemia, Grade 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 2; Phase

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Urinalysis Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b] [1 year]. Count Of Participants, Participants. Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=4): 1; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=16): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) [Phase 2] [1 year].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Number, nanograms per milliliter (ng/mL). Individual value for Participant 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=2): 3390. Individual value for Participant 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=2): 2950.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Geometric Mean, ng/mL (Geometric Coefficient of Variation). Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=13): 1276 (52).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Number, hours (hr). Individual value for Participant 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=2): 1.00. Individual value for Participant 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=2): 3.02.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Median, hours (hr) (Full Range). Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=13): 1.42 (0.500 to 5.95).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Number, nanogram*hour/milliliter (ng*hr/mL). Individual value for Participant 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=2): 15700. Individual value for Participant 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=2): 10600.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Geometric Mean, ng*hr/mL (Geometric Coefficient of Variation). Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=13): 5873 (36).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Number, ng/mL. Individual value for Participant 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=2): 436. Individual value for Participant 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=2): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Geometric Mean, ng/mL (Geometric Coefficient of Variation). Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=13): 72.34 (NA) [NA for geometric coefficient of variation as there were participants with a zero value (ie, Cmin below the limit of quantification).].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Number, Liters per hour (L/hr). Individual value for Participant 1: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=2): 47.8. Individual value for Participant 2: Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=2): 70.5.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Geometric Mean, Liters per hour (L/hr) (Geometric Coefficient of Variation). Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=13): 85.09 (36).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Plasma Decay Half-Life (t1/2) for Cycle 1 Day 15 [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Mean, hours (hr) (Standard Deviation). Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=1): 1.18 (NA) [NA for standard deviation as only 1 participant had data for t1/2.]; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=10): 3.41 (0.996).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

PF-04136309 Apparent Volume of Distribution (Vz/F) for Cycle 1 Day 15 [Phase 1b] [Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)]. Geometric Mean, Liters (L) (Geometric Coefficient of Variation). Phase 1b: PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine (n=1): 120 (NA) [NA for geometric coefficient of variation as only 1 participant had data for Vz/F.]; Phase 1b: PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine (n=10): 398.3 (NA) [NA for geometric coefficient of variation as there were missing values for Vz/F.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Ex Vivo Inhibition of Chemokine Ligand 2 (CCL2)-Induced Extracellular Signal Regulated Kinase (ERK) Phosphorylation in the Peripheral Blood [Phase 1b] [Cycle 1 Day 1 pre-dose, 2 and 6 hours post-dose, and 12 hours (pre-second BID dose-optional collection); Cycle 1 Days 2, 3 and 4 pre-dose].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Overall Survival (OS) [Phase 2] [Up to approximately 13.5 months].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Treatment-Emergent Adverse Events (AEs) [Phase 2] [Up to approximately 1 year].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Laboratory Abnormalities by Severity [Phase 2] [Up to approximately 1 year].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Objective Response Rate (ORR) [Phase 2] [Up to approximately 1 year].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Objective Response (DR) [Phase 2] [Up to approximately 1 year].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Progression (TTP) With the Double Combination PF-04136309 and Gemcitabine (Maintenance Therapy) After Interruption of Nab-paclitaxel [Phase 2] [Up to approximately 1 year].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Trough PF-04136309 Concentrations [Phase 2] [Cycle 1 Day 1 pre-dose, Cycle 1 Days 2, 8 and 15 pre-dose; Day 1 of Cycle 2 and subsequent cycles pre-dose, and EOT visit].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change From Baseline in Pharmacodynamic (PD) Markers in Metastatic Tumors and Bone Marrow [Phase 2] [Baseline, Cycle 1 Day 28 or Cycle 2 Day 28; EOT visit (optional) for CNB].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Peripheral Neurological Adverse Events [Phase 2] [Up to approximately 1 year].

Papers 1