Clinical trial · Interventional
ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer
ARMOR1: Phase 1, Open Label, Dose Escalation Trial of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Cancer
NCT00959959CI-TRIAL-00046988ARMOR1completedPhase 1ClinicalTrials.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)
The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC).
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 |
|---|---|---|---|
| TOK-001 | Drug | Galeterone | ALIAS |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- 650 mg TOK-001
- interventionNames
- Drug: TOK-001
- type
- EXPERIMENTAL
- label
- 1300 mg TOK-001
- interventionNames
- Drug: TOK-001
- type
- EXPERIMENTAL
- label
- 1950 mg TOK-001
- interventionNames
- Drug: TOK-001
- type
- EXPERIMENTAL
- label
- 975 mg TOK-001
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent form * Confirmed cancer of the prostate * Progressing disease in spite of androgen ablation therapy * Able to swallow multiple capsules Exclusion Criteria: * Participation in another clinical trial \< 4 weeks prior to enrollment * Metastatic disease with one or more of the following: * Liver involvement * Bone pain associated with confirmed evidence of metastases * Non-hepatic visceral involvement * The following medications: * Prior treatment with MDV3100, abiraterone, Provenge or TAK700 * Prior treatment with ketoconazole * Prior treatment with chemotherapy * Prior radiation therapy completed ≤ 4 weeks prior to enrollment * The following medical conditions: * Active angina pectoris * History of Hepatitis B or Hepatitis C * Known HIV infection * Ongoing hypertension Note: There are additional inclusion and exclusion criteria. The clinical site center will determine if you are eligible. If you are not eligible for the trial, site staff will detail the reasons to you.
References
Publications (0)
Data not yet available
No reference posted for this study.