Baxalta- 391401 Part 2 BAX69 - Metastatic colorectal cancer
Research type
Research Study
Full title
A Phase 2a Randomized, Open-label Study to Assess the Safety, Tolerability, and Efficacy of BAX69 in Combination with 5-FU/Leucovorin or Panitumumab versus Standard of Care in Subjects with Metastatic Colorectal Cancer
IRAS ID
187040
Contact name
Alan Anthoney
Contact email
Sponsor organisation
Baxalta US Inc.
Eudract number
2015-000896-28
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
This study is being sponsored by Baxalta US Inc.
Purpose:
The purpose of this study, in subjects with progressive measurable metastatic colorectal cancer (mCRC), is as follows:
• To evaluate the safety and tolerability of BAX69 in combination with 5-fluorouracil (5-FU)/leucovorin (LV) or panitumumab to determine the recommended phase 2 dose (RP2D) of each combination.
• To compare the efficacy of BAX69 in combination with 5-FU/LV versus standard of care (SoC) (Investigator choice) as third or fourth treatment line in subjects with KRAS (a gene that encodes a protein which is involved in normal tissue signalling) mutated (mut) and/or NRAS (a gene that encodes a protein which is involved in normal tissue signalling) mut tumours
• To compare the efficacy of BAX69 in combination with panitumumab versus SoC (investigator choice) as third or fourth treatment line in subjects with KRAS wild type (wt) and NRAS wt tumours.Furthermore, the pharmacokinetic (PK) profile of BAX69 in combination with 5-FU/LV or panitumumab will be characterised, and limited pharmacodynamic (PD) serum markers will be explored.
Participation:
Subject participation includes a maximum of 3 weeks for screening, and 30 (±2) days for post-treatment safety follow-up. Subjects will receive treatment until disease progression, unacceptable toxicity, or withdrawal of consent. Subjects will be followed until progression is clinically or radiologically documented.
The duration of the study is estimated as a total of 21 months, inclusive of approximately 15 months to complete accrual, followed by approximately 6 months for primary outcome measure. Study completion is estimated to occur when 75% of OS events have been reported.
Inclusion criteria
Patients above the age of 18 with histologically or cytologically confirmed diagnosis of colorectal cancer, metastatic colorectal cancer not amenable to surgical resection with a known KRAS, NRAS mutation status (if unknown status for either of these genes, and no archival tissue is available, a fresh tumour biopsy will be made).
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0422
Date of REC Opinion
13 Nov 2015
REC opinion
Further Information Favourable Opinion