Study of PM060184 in Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: PM060184

• Registration Number: NCT01299636
• Lead Sponsor: PharmaMar

Brief Summary

The purpose of the study is to determine the maximum tolerated dose and the recommended dose and to evaluate the safety and tolerability of PM060184.

Detailed Description

This trial intends to determine the maximum tolerated dose and the recommended dose, to evaluate the safety and tolerability, to determine the pharmacokinetics and to evaluate the antitumor activity of PM060184 in patients with advanced solid tumors.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PM060184	PM060184	-

Primary Outcome Measures

Name	Time	Method
MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.	From treatment onset to end of treatment	To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM060184 administered on Days 1 and 8 of a 21-day cycle intravenously (i.v.) over 10 minutes to patients with advanced solid tumors.

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetics of this drug in patients who have advanced solid tumors.	Blood samples will be collected up to 48 hours after the first infusion. At the RD, 24-h urine collection samples and 15 additional blood samples up to 48 hours after the second infusion of the first cycle.	The complete plasma concentration-time profiles of PM06184 will be analyzed by standard non-compartmental methods.The percent of PM060184 total dose excreted unchanged into the urine over the collection interval will be calculated from the urine samples.
Antitumor activity	Every six weeks while on treatment. Patients who discontinued treatment without disease progression will be followed every three months until disease progression, other antitumor therapy, death or until the end-of-study date, whichever occurs first.	Antitumor activity will be measured according to the RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 or by evaluation of tumor markers

Trial Locations

Locations (1)

START- South Texas Accelerated Research Therapeutics, LLC; 🇺🇸 San Antonio, Texas, United States