Metastatic Colorectal Carcinoma Clinical Trial
Official title:
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
| Verified date | December 2015 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 18 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | The Ottawa Hospital Cancer Centre | Ottawa | Ontario |
| Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
| United States | Metrohealth Medical Center | Cleveland | Ohio |
| United States | St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare | Fullerton | California |
| United States | Comprehensive Cancer Centers of Nevada | Henderson | Nevada |
| United States | Comprehensive Cancer Centers of Nevada | Henderson | Nevada |
| United States | Comprehensive Cancer Centers of Nevada Research Department | Henderson | Nevada |
| United States | UCLA Hematology Oncology | Irvine | California |
| United States | Kadlec Clinic Hematology and Oncology | Kennewick | Washington |
| United States | Comprehensive Cancer Centers for Nevada | Las Vegas | Nevada |
| United States | COmprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| United States | Comprehensive Cancer Centers of NV | Las Vegas | Nevada |
| United States | Drug Management Only: UCLA West Medical Pharmacy | Los Angeles | California |
| United States | Drug Management Only: UCLA West Medical Pharmacy, Attn Steven L. Wong, Pharm .D. | Los Angeles | California |
| United States | Ronald Regan UCLA Medical Center | Los Angeles | California |
| United States | Ronald Regan UCLA Medical Center, Drug Information Center | Los Angeles | California |
| United States | TRIO-US Central Administration | Los Angeles | California |
| United States | TRIO-US Central Administration, Regulatory Management Only | Los Angeles | California |
| United States | TRIO_US | Los Angeles | California |
| United States | UCLA Hematology Oncology Administrative Address | Los Angeles | California |
| United States | UCLA West Medical Pharmacy | Los Angeles | California |
| United States | UCLA West Medical Pharmacy, Att: Steven L/ Wong, Pharm D. | Los Angeles | California |
| United States | Westwood Bowyer Clinic, Peter Morton Medical Building | Los Angeles | California |
| United States | West Valley Hematology/Oncology Medical Group | Northridge | California |
| United States | UCLA/Pasadena Healthcare | Pasadena | California |
| United States | Western Institutional Review Board | Pulyallup | Washington |
| United States | Kadlec Medical Center | Richland | Washington |
| United States | Outpatient Imaging Center | Richland | Washington |
| United States | Central Coast Pathology Consultants | San Luis Obispo | California |
| United States | Central Coast Medical Oncology Corporation | Santa Maria | California |
| United States | Marian Medical Center Clinical Laboratory | Santa Maria | California |
| United States | UCLA Hematology Oncology | Santa Monica | California |
| United States | UCLA Santa Monica Medical Center & Orthopaedic Hospital | Santa Monica | California |
| United States | Investigational Drug Services | Seattle | Washington |
| United States | Virginia Mason Medical Center, Dept of Hematology and Oncology | Seattle | Washington |
| United States | Medical Group of the Carolinas - Hematology Spartanburg | Spartanburg | South Carolina |
| United States | Spartanburg Regional Medical Center | Spartanburg | South Carolina |
| United States | Medical Oncology Associates, PS | Spokane | Washington |
| United States | Spokane Valley Cancer Center | Spokane Valley | Washington |
| United States | UCLA/Santa Clarita Valley Cancer Center | Valencia | California |
| United States | Quest Diagnostic | West Hills | California |
| United States | UCLA Cancer Center | Westlake Village | California |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Canada, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with Dose-limiting toxicities (DLT) | DLTs occuring in the first cycle of therapy | 28 days | Yes |
| Primary | Progression-Free Survival (PFS) | Time from randomization date to date of first documentation of progression or death due to any cause, whichever occurs first | 12 months | No |
| Secondary | Percentage of Participants With Objective Response | Percentage of participants with OR based assessment of complete remission (CR) or partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. | 12 months | No |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Single dose PK will be characterized by noncompartmental analysis of the concentration-time data. | Day 1: 0 (pre-dose), 0.5, 1, 2, 4, 6, 24, 72 and 120 hours. D3: 0 (pre-dose), 30 min, 1, 2, 4, 6, 24, 72, and 120 hours. Cycle 2-6: Day 3: 0 (pre-dose), 30 min. | No |
| Secondary | The number of patients in each treatment Arm with expression and/or phosphorylation in PI3K pathway proteins in biopsied tumor tissue | Baseline | No | |
| Secondary | The number of patients in each treatment Arm with expression and/or phosphorylation in PI3K pathway proteins in biopsied tumor tissue | 28 days | No | |
| Secondary | The number of patients in each treatment Arm with gene and/or protein expression biomarkers relating to the PI3K and/or mTOR pathway activation in their biopsied tumor tissue | Baseline | No | |
| Secondary | QTc interval | To characterize the potential for prolonged QTc interval. | Screening up to 6 months | Yes |
| Secondary | FACT-C | patient reported outcome instruments (self-administered questionnaire) | Baseline up to 10 months | No |
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