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Clinical Trial of PM60184 in Advanced Colorectal Cancer After Standard Treatment

NCT03427268 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-05-24

Study results available
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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

  • Advanced Colorectal Cancer

Interventions

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).

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2019-02-11
Completion
2019-02-11
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03427268 on ClinicalTrials.gov