Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 131 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01075048
The ClinicalTrials.gov registry entry for NCT01075048 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01075048 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.