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Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer

NCT02448810 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2021-05-25

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of BAX69 in combination with 5-fluorouracil (5-FU)/leucovorin (LV) or panitumumab to determine the recommended phase II dose (RP2D) of each combination; and to compare the efficacy between BAX69 in combination with 5-FU/LV for subjects with KRAS or NRAS mutated tumor (mt) or panitumumab, for subjects with KRAS and NRAS wild type tumor (wt) and standard of care (SoC) per investigator choice as third or fourth treatment line in subjects with progressive measurable metastatic colorectal cancer (mCRC).

Conditions

Interventions

BIOLOGICAL

BAX69 + infusional 5-FU/LV

Study Part 1: Safety Run-in * Administered weekly as part of a 4 week treatment cycle * Intravenous injection

BIOLOGICAL

BAX69 + panitumumab

Study Part 1: Safety Run-in * Administered weekly as part of a 4 week treatment cycle * Intravenous injection

BIOLOGICAL

BAX69 + 5-FU/LV

Study Part 2: Administered weekly as part of a 4 week treatment cycle •Intravenous injection

BIOLOGICAL

BAX69 + panitumumab

Study Part 2: Administered weekly as part of a 4 week treatment cycle •Intravenous injection

DRUG

Standard of Care

* Investigator's choice * Dose according to drug label

BIOLOGICAL

Standard of Care

* Investigator's choice * Dose according to drug label * Choice includes panitumumab in KRAS \&NRAS wt group only

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-15
Primary Completion
2017-02-15
Completion
2017-02-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02448810 on ClinicalTrials.gov