Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- PM060184
- Conditions
- Solid Tumors
- Sponsor
- PharmaMar
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PM060184
Intervention: PM060184
Outcomes
Primary Outcomes
MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.
Time Frame: 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 Outcomes
- 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.)
- 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.)