Clinical Trial of PM60184 in Advanced Colorectal Cancer After Standard Treatment

Phase 2

Completed

• Conditions: Advanced Colorectal Cancer
• Interventions: Drug: PM060184

• Registration Number: NCT03427268
• Lead Sponsor: PharmaMar

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-20
• Study Start: 2018-01-16
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-09
• Primary Completion: 2019-02-11
• Study Completion: 2019-02-11
• Results First Submitted: 2021-03-22
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-30
• Last Update Submitted: 2021-04-30
• Results First Posted: 2021-05-24
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PM060184	PM060184	PM060184

Primary Outcome Measures

Name	Time	Method
Progression-free Survival Rate at Three Months	Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 3 months	Progression-free survival rate at 12 weeks (PFS3), defined as the rate estimate of the percentage of patients who are alive and progression-free at 12 weeks (\~3 months) after the first treatment administration. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From the first day of treatment to the date of death or last contact, up to 12 months	Overall Survival (OS), defined as the time from the first day of treatment to the date of death or last contact.
Progression Free Survival (PFS)	Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months	Progression-free survival (PFS), defined as the time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Overall Response Rate (ORR)	Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months	Overall Response Rate defined as the percentage of patients with either complete response (CR) or partial response (PR) according to RECIST v.1.1.; CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors

Trial Locations

Locations (5)

ES002; 🇪🇸 Valencia, Spain

CA001; 🇨🇦 Toronto, Ontario, Canada

ES001; 🇪🇸 Barcelona, Spain

US017; 🇺🇸 Los Angeles, California, United States

ES009; 🇪🇸 Madrid, Spain