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
- lurbinectedin (PM01183) — DRUG
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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sarcoma Oncology Research Center, LLC | Santa Monica | California | 90403 | - |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | - |
| Beth Israel Deaconess Medical Centre | Boston | Massachusetts | 02215 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| Massachussets General Hospital | Boston | Massachusetts | 02114 | - |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
| Institute for Drug Development, Cancer Therapy & Research Center at University of Texas Health Science Center | San Antonio | Texas | 78229 | - |
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