Clinical trial · Interventional
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
NCT01296243CI-TRIAL-00007535unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tesetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tesetaxel once every 3 weeks
- interventionNames
- Drug: Tesetaxel
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 6 months from the start of treatment
Secondary outcomes (8)
- measure
- Response rate (RECIST 1.1) among patients with measurable disease
- timeFrame
- 6 months from the start of treatment
- measure
- Duration of response among patients with measurable disease
- timeFrame
- 12 months from the start of treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * At least 18 years of age * Histologically confirmed prostate cancer, currently with progressive disease * Evidence of metastatic disease * Castrate level of testosterone (\< 50 ng/dL) * Eastern Cooperative Oncology Group performance status 0 or 1 * Chemotherapy-naïve * Adequate bone marrow, hepatic, and renal function * Ability to swallow an oral solid-dosage form of medication Key Exclusion Criteria: * History or presence of brain metastasis or leptomeningeal disease * Operable cancer * Uncontrolled diarrhea * Uncontrolled nausea or vomiting * Known malabsorptive disorder * Currently active second malignancy other than non-melanoma skin cancers * Human immunodeficiency virus (HIV) infection based on history of positive serology * Significant medical disease other than cancer * Presence of neuropathy \> Grade 2 (National Cancer Institute Common Toxicity Criteria \[NCI CTC\]; v4.0) * Need for other anticancer treatment * Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity * Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity * Less than 4 weeks since use of another investigational agent
References
Publications (0)
Data not yet available
No reference posted for this study.