Terminated
PHASE2
INTERVENTIONAL
NCT02448810
Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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).
Interventions
Name:
BAX69 + infusional 5-FU/LV
Type:
BIOLOGICAL
Description:
Study Part 1: Safety Run-in
* Administered weekly as part of a 4 week treatment cycle
* Intravenous injection
Name:
BAX69 + panitumumab
Type:
BIOLOGICAL
Description:
Study Part 1: Safety Run-in
* Administered weekly as part of a 4 week treatment cycle
* Intravenous injection
Name:
BAX69 + 5-FU/LV
Type:
BIOLOGICAL
Description:
Study Part 2: Administered weekly as part of a 4 week treatment cycle
•Intravenous injection
Name:
BAX69 + panitumumab
Type:
BIOLOGICAL
Description:
Study Part 2: Administered weekly as part of a 4 week treatment cycle
•Intravenous injection
Name:
Standard of Care
Type:
DRUG
Description:
* Investigator's choice
* Dose according to drug label
Name:
Standard of Care
Type:
BIOLOGICAL
Description:
* Investigator's choice
* Dose according to drug label
* Choice includes panitumumab in KRAS \&NRAS wt group only
Primary Outcomes
Measure:
Part 2: Progression-Free Survival (PFS)
TimeFrame:
From start of the study up to safety follow-up visit occurred (30 [-/+7]) days after the last dose of study treatment or until disease progression
Description:
PFS was defined as time between treatment initiation and tumor progression (per Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1 criteria) or death from any cause, with censoring of participants who were lost to follow-up or withdrew consent.
Measure:
Part 1: Number of Participants With Occurrence of Dose Limiting Toxicity (DLT)
TimeFrame:
From start of study treatment up to 28 days
Description:
DLT was defined as any drug-related treatment-emergent adverse event (TEAE) (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v4.03) that occurs during the first 28 days after treatment start and that meets any of the following criteria: i) Any \>= Grade 3 non-hematologic toxicity (excluding: mucositis/stomatitis of Grade 3; diarrhea of \<3 days duration; nausea and vomiting \<3 days duration; fatigue of \<7 days duration; alopecia; single laboratory value out of the normal range that has no clinical significance and that resolves to \<= Grade 2 with adequate measures within 7 days) ii) Any Grade 4 hematologic toxicity (excluding: grade 4 neutropenia lasting for \<= 5 days; isolated grade 4 lymphocytopenia) iii) Grade 3 febrile neutropenia iv) Grade 3 thrombocytopenia associated with bleeding v) Any life-threatening complication or abnormality not covered in NCI CTCAEv4.03.
Trial Information
NCT ID
NCT02448810
Status
Terminated
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Baxalta now part of Shire
Last Updated
December 15, 2025