Trials / Unknown
UnknownNCT01296243
Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer
A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have Progressive, Castration-resistant Prostate Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (estimated)
- Sponsor
- Genta Incorporated · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Given the activity of docetaxel in patients with progressive, metastatic castration-resistant prostate cancer, this study is being undertaken to evaluate the activity of tesetaxel, an orally bioavailable taxane, in chemotherapy-naive and chemotherapy-exposed patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tesetaxel | Tesetaxel capsules will be administered orally once every 21 days until progression, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria. The duration of protocol therapy will not exceed 12 months. Treatment will be initiated at a dose of 27 mg/m2; dose escalation to a maximum of 35 mg/m2 is allowed in Cycle 2 depending on tolerability. |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2012-08-01
- Completion
- 2015-02-01
- First posted
- 2011-02-15
- Last updated
- 2012-07-24
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01296243. Inclusion in this directory is not an endorsement.