NCT01937715|TerminatedPhase 1Results

Study Stopped

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

A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

An Open-Label, Multi-Center, Randomized Phase 1b/2 Study Of PF-05212384 Plus 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

Pfizer ClinicalTrials.gov

Compare

2 other identifiers

B21510072013-002096-18

Study Type

interventional

Target

Locations

3 countries

Sites

Timeline

RegisteredSep 2013

StartedFeb 2014

CompletionAug 2015

Brief Summary

This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI. The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Feb 2014

Geographic Reach

3 countries

39 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

August 27, 2013

Completed

13 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed

5 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed

1 year until next milestone

Results Posted

Study results publicly available

August 18, 2016

Completed

Last Updated

August 18, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

August 27, 2013

Results QC Date

July 8, 2016

Last Update Submit

July 8, 2016

Conditions

Metastatic Colorectal Carcinoma

Outcome Measures

Primary Outcomes (2)

Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle of Therapy
DLTs were classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and defined as any of the following events judged to be attributed to the combination of PF-05212384 plus FOLFIRI: hematologic (febrile neutropenia or a sustained temperature \>=38 degrees Celcius for \>1 hour, grade \>=3 neutropenic infection, grade 3 thrombocytopenia with bleeding, grade 4 thrombocytopenia); non-hematologic (grade \>=2 pneumonitis, grade \>=3 toxicities, toxicities which resulted in failure to deliver at least 75% of the planned total dose of PF-05212384 and/or 50% of the planned total dose of FOLFIRI during the first cycle, toxicities which resulted in delay of start of Cycle 2 by \>2 weeks of scheduled day (Day 43 of study), Grade 3 QTc prolongation).
Day 1 up to Day 28
Progression-Free Survival (PFS)
Progression-free survival was the time from randomization the date to date of first documentation of progression or death due to any cause, whichever occurred first. Documentation of progression was by objective disease assessment as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Baseline (Day 1) up to disease progression or death whichever occurred first (up to 18 months)

Secondary Outcomes (21)

Number of Participants With Best Overall Response (Phase 1B)
Every 8 weeks from Cycle 1 Day 1 until 28 days of last dose
Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations by Relationship and Seriousness
Baseline up to final study evaluation (within 28 days of last dose)
Number of Participants With All Causality AEs by System Organ Class (SOC)
Baseline up to final study evaluation (within 28 days of last dose)
Number of Participants With Treatment-Emergent AEs by Worst On-Study Grade
Baseline up to final study evaluation (within 28 days of last dose)
Number of Participants With Hematological Test Abnormalities
Day 1 and Day 15 of each cycle
+16 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

PF-05212384 plus FOLFIRI

Drug: PF-05212384Drug: FOLFIRI regimen

Arm B

ACTIVE COMPARATOR

Bevacizumab plus FOLFIRI

Biological: BevacizumabDrug: FOLFIRI

Interventions

PF-05212384DRUG

PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly

Arm A

FOLFIRI regimenDRUG

The RP2D/MTD dose of FOLFIRI regimen every 2 weeks

Arm A

BevacizumabBIOLOGICAL

5 mg/m\^2 every 2 weeks or 7.5 mg/m\^2 every 3 weeks

Arm B

FOLFIRIDRUG

Full dose FOLFIRI regimen every 2 weeks

Arm B

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Advanced colorectal carcinoma.
Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
Tumor tissue available at time of screening for molecular profiling.
Adequate performance status.
Adequate glucose control, bone marrow, kidney, liver, and heart function.

You may not qualify if:

Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation.
Prior irinotecan treatment.
Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
History of Gilbert's syndrome.
Active brain metastases.
Deep vein thrombosis in the preceding 2 months.
History of interstitial lung disease.
RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (39)

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

Fullerton, California, 92835, United States

Location

UCLA Hematology Oncology

Irvine, California, 92604, United States

Location

Drug Management Only: UCLA West Medical Pharmacy, Attn Steven L. Wong, Pharm .D.

Los Angeles, California, 90095-7349, United States

Location

Drug Management Only: UCLA West Medical Pharmacy

Los Angeles, California, 90095-7349, United States

Location

UCLA West Medical Pharmacy, Att: Steven L. Wong, Pharm D.

Los Angeles, California, 90095-7349, United States

Location

Ronald Reagan UCLA Medical Center