Trials / Terminated
TerminatedNCT02448810
Phase 2a Study of BAX69 and 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects With Metastatic Colorectal Cancer
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2015-06-15
- Primary completion
- 2017-02-15
- Completion
- 2017-02-15
- First posted
- 2015-05-20
- Last updated
- 2021-05-25
- Results posted
- 2018-03-19
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02448810. Inclusion in this directory is not an endorsement.