Trials / Completed
CompletedNCT01525602
Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors
A Phase 1b Study to Assess the Safety of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This was a 3-part study designed to explore the safety and tolerability of escalating doses of PLX3397 with weekly paclitaxel to establish a recommended Phase 2 dose (RP2D), to confirm RP2D in participants with advanced non-resectable solid tumors, and to determine the efficacy of PLX3397 600 mg twice daily (BID) administered in combination with weekly paclitaxel in participants with advanced, metastatic or non-resectable, platinum-resistant or -refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PLX3397 | PLX3397 tablets, 200mg |
| DRUG | Paclitaxel | Paclitaxel IV |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2017-12-01
- Completion
- 2018-02-01
- First posted
- 2012-02-03
- Last updated
- 2020-07-16
- Results posted
- 2020-07-16
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01525602. Inclusion in this directory is not an endorsement.