Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Part of paid clinical trials in Santa Monica, California.

Sponsor
PharmaMar
Study ID
NCT02454972
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors

Key Dates

Start date
Aug 25, 2015
Status verified
Feb 2023
Primary completion
Sep 18, 2020
Completion
Sep 18, 2020

Study Design

Enrollment
345 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: lurbinectedin (PM01183)
    lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) ]

Locations (7)

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