Trials / Completed
CompletedNCT03427268
Clinical Trial of PM60184 in Advanced Colorectal Cancer After Standard Treatment
A Phase II, Open-label, Multicentre Study of PM060184 in Patients With Advanced Colorectal Cancer After Standard Treatment.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- PharmaMar · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial will evaluate the efficacy of PM060184 in terms of progression-free survival at 12 weeks (PFS3) in advanced or metastatic Colorectal Cancer (CRC) patients with any KRAS mutation status (wild- type; mutated; or unknown status) progressing after standard treatments (fluoropyrimidine, irinotecan, and oxaliplatin). Patients in this trial will receive PM060184 at a dose of 9.3 mg/m2 as a 30-minute intravenous (i.v.) infusion on Days 1 and 8 q3wk.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PM060184 | PM060184: 9.3 mg/m2 PM060184 i.v. as a 30-minute infusion via a central or peripheral venous catheter.Dose can be rounded to the first decimal point. PM060184 will be administered on Day 1 and Day 8 q3wk. (Three weeks=one treatment cycle). |
Timeline
- Start date
- 2018-01-16
- Primary completion
- 2019-02-11
- Completion
- 2019-02-11
- First posted
- 2018-02-09
- Last updated
- 2021-05-24
- Results posted
- 2021-05-24
Locations
5 sites across 3 countries: United States, Canada, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03427268. Inclusion in this directory is not an endorsement.