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NCT01075048 · ClinicalTrials.gov registry record · Phase 1
ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 131
- Enrollment target
NCT01075048: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT01075048 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 131 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (118% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01075048, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 131 participants
- Enrollment target
Study Summary
ARQ 197 or placebo in combination with irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC), in participants with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the recommended dose for Phase 2. After the recommended dose is determined for Phase 2, participants receive study drug or placebo with irinotecan and cetuximab.
Primary Outcome
Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause (as of data cutoff 12 Oct 2012).
Interventions
- DRUG Placebo
- DRUG Cetuximab
- DRUG Irinotecan
- DRUG Tivantinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2010-01-26 |
| Est. Completion | 2015-02-20 |
| Phase | Phase 1 |
What the finished NCT01075048 record still lists
NCT01075048 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (118% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01075048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01075048 about?
NCT01075048 is a clinical study titled "ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer". ARQ 197 or placebo in combination with irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC), in participants with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the recommended dose...
What is the current status of trial NCT01075048?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 131 participants. The study started on 2010-01-26. Estimated completion is 2015-02-20.
What interventions are being tested in trial NCT01075048?
The interventions under investigation include: Placebo (DRUG), Cetuximab (DRUG), Irinotecan (DRUG), Tivantinib (DRUG).
Who is sponsoring clinical trial NCT01075048?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01075048's enrollment target sits among peer trials
131 439th of 2000 higher than 1,562 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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