Trials / Completed
CompletedNCT01831089
Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Weekly Paclitaxel, With or Without Bevacizumab, in Patients With Selected Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- PharmaMar · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors
Detailed description
Clinical trial to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with weekly paclitaxel, with or without bevacizumab. Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a selected cohort of patients to characterize the safety profile and feasibility of this combination, to obtain preliminary information on antitumor activity, to obtain preliminary information on quality of life (QoL), to characterize the pharmacokinetics (PK) of this combination and to detect major drug-drug PK interactions and PK(pharmacokinetic)/PD(pharmacodynamic) correlation and to conduct an exploratory pharmacogenomic(PGx) analysis in patients with selected advanced solid tumors.
Conditions
- Breast Cancer
- Ovarian Cancer
- Gynecological Cancer
- Head and Neck Carcinoma
- Non-small Cell Lung Cancer
- Small Cell Lung Cancer
- Non-squamous Cell Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PM01183 + paclitaxel +/- bevacizumab | PM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion paclitaxel: 6 mg/ml concentrate for solution for infusion bevacizumab: 25 mg/ml concentrate for solution for infusion Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a prospectively selected cohort of patients |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2013-04-15
- Last updated
- 2020-04-10
- Results posted
- 2020-03-20
Locations
3 sites across 3 countries: United States, Spain, Switzerland
Source: ClinicalTrials.gov record NCT01831089. Inclusion in this directory is not an endorsement.