Trials / Completed
CompletedNCT01204099
Study of PX-866 and Docetaxel in Solid Tumors
Phase 1/2 Study of PX-866 and Docetaxel in Patients With Solid Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 223 (actual)
- Sponsor
- Cascadian Therapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1: To determine the maximally tolerated dose (MTD) or recommended dose (RD) and any potential efficacy of PX-866 in combination with docetaxel in patients with solid tumors. Phase 2: To determine the antitumor activity and safety of PX-866 in combination with docetaxel versus docetaxel alone in patients with NSCLC or SCCHN.
Detailed description
This is a Phase 1/2 open-label study. In the Phase 1 part of the study, PX-866 was given in combination with docetaxel to patients with incurable locally advanced, recurrent or metastatic cancer. Phase 2 of the study is an open-label, randomized evaluation of the antitumor activity and safety of PX-866, administered at the MTD/RD identified in Phase 1 (8mg daily), in combination with docetaxel versus docetaxel alone in patients with locally advanced, recurrent, or metastatic NSCLC (Group 1) or patients with locally advanced, recurrent, or metastatic SCCHN (Group 2). Group 1 (patients with locally advanced, recurrent, or metastatic NSCLC) is now closed to enrollment. All treatments will be administered on a 21-day cycle. Docetaxel 75 mg/m2 will be administered IV on Day 1 of each 21-day cycle. PX-866 will be administered orally or via PEG tube (if applicable) once per day on Days 1 to 21 of all treatment cycles in patients randomized to the treatment arm containing PX-866. Patients will be evaluated for progression approximately every 6 weeks. Patients with stable disease (SD) or better, per investigator assessment, will receive repeat cycles of treatment on a 21-day schedule until disease progression, unacceptable toxicity or withdrawal of consent.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Docetaxel | |
| DRUG | PX-866 |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2013-12-01
- Completion
- 2014-02-01
- First posted
- 2010-09-17
- Last updated
- 2018-05-16
Locations
33 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01204099. Inclusion in this directory is not an endorsement.