Trials / Completed
CompletedNCT02454972
Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 345 (actual)
- Sponsor
- PharmaMar · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors
Detailed description
Patients with relapsed small cell lung cancer (SCLC), head and neck carcinoma (H\&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs) will be enrolled in nine different cohorts. Up to 25 evaluable patients are planned to be enrolled in each cohort (50 in the endometrial carcinoma and 100 in the SCLC cohort).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lurbinectedin (PM01183) |
Timeline
- Start date
- 2015-08-25
- Primary completion
- 2020-09-18
- Completion
- 2020-09-18
- First posted
- 2015-05-27
- Last updated
- 2023-03-02
- Results posted
- 2021-11-22
Locations
40 sites across 9 countries: United States, Belgium, France, Germany, Italy, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT02454972. Inclusion in this directory is not an endorsement.