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Safety Study of Regorafenib With PF-03446962 to Treat Colorectal Cancer

NCT02116894 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-03-14

No results posted yet for this study

Summary

The primary objective of this open-label phase Ib trial is to determine the maximum tolerated dose and the recommended phase II dose for the combination of PF-03446962 plus regorafenib in patients with metastatic colorectal cancer. The secondary objectives are to describe the safety and tolerablility, and to describe the clinical activity of PF-03446962 plus regorafenib in terms of response rate and progression free survival

Conditions

Interventions

BIOLOGICAL

PF-03446962

PF-03446962 will be an investigational formulation supplied by Pfizer . PF-03446962 injection, 10 mg/mL is presented as a sterile solution for IV administration in a formulation consisting of precedented excipients. We will be administering PF-03446962 intravenously at a starting dose of 4.5 mg/kg and escalating to up to 7 mg/kg.

DRUG

Regorafenib

We will be administering regorafenib on-label for the indication of metastatic colorectal cancer. The indicated dose is 160 mg once daily for the first 21 days of a 28 day cycle. We will start at a regorafenib dose of 120 mg in the combination therapy, but may increase to 160 mg during dose escalation.

Sponsors & Collaborators

Principal Investigators

  • Herbert Hurwitz, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-02-29
Completion
2016-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116894 on ClinicalTrials.gov