Trials / Terminated
TerminatedNCT01930292
Debio 1143 in Combination With Carboplatin and Paclitaxel in Patient With Advanced Solid Malignancies
A Phase I Study to Evaluate the Safety and Determine the Maximum Tolerated Dose (MTD) of Debio 1143 Combined With Carboplatin and Paclitaxel in Patients With Squamous Non-Small Cell Lung Cancer (NSCLC), Platinum-refractory Ovarian Cancer, and Basal-like/Claudin Low Triple Negative Breast Cancer (TNBC)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Debiopharm International SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC). The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin. The primary objective of Part B is to consolidate the safety profile of the recommended dose of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Part A: Debio 1143 | Adaptive doses of Debio1143 oral capsules, between 50 and 400 mg until the recommended dose (RD) is determined. |
| DRUG | Paclitaxel | Paclitaxel standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle, after pre-medication to prevent severe hypersensitivity reactions. |
| DRUG | Carboplatin | Carboplatin standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle. |
| DRUG | Part B: Debio 1143 | RD of Debio1143 oral capsules, once daily for five consecutive days starting on day 1 or 2 of each 21-day treatment cycle. |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2013-08-28
- Last updated
- 2016-03-24
Locations
4 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01930292. Inclusion in this directory is not an endorsement.