Clinical trial · Interventional
Dose-Escalation and Safety Study of APC-100 for the Treatment of Prostate Cancer
Phase 1/2a, Open-Label, Dose-Escalation and Safety Study of APC-100 [Pentamethylchromanol, 2,2,5,7,8-Pentamethyl-6] in Men With Advanced Prostate Cancer
NCT01436214CI-TRIAL-00018567unknownPhase 1 / Phase 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)
This study is a phase 1/2a, open label, dose escalation and safety study of APC-100 (2,2,5,7,8-Pentamethyl-6-chromanol) in men with advanced prostate cancer.
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 |
|---|---|---|---|
| APC-100 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- APC-100
- interventionNames
- Drug: APC-100
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose
- timeFrame
- Within 12 weeks following treatment
- description
- Determination of the MTD based on documentation of dose-limiting toxicities (DLTs) and adverse events. Eighteen patients will be accrued for this part of the study. The MTD will be determined based on both the acute DLTs (within the first cycle of treatment) and late (within cycles 2 through 3) DLTs of APC-100. The establishment of a recommended phase 2a dose will be based on toxicity (DLTs within the first 28 days) and tolerability (DLTs within the first 12 weeks) of APC-100.
Secondary outcomes (3)
- measure
- Plasma Pharmacokinetics (PK) profile of APC-100
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histopathologically proven adenocarcinoma of the prostate * Patients must have progressive disease * Patients must have had prior treatment with bilateral orchiectomy or androgen deprivation therapy with an LHRH-blocker with evidence of treatment failure Exclusion Criteria: * Patients treated with other secondary hormonal therapies * Patients with prior chemotherapy given for castrate-resistant prostate cancer * Patients with prior radiation therapy completed less than 4 weeks prior enrollment * Patients with prior investigational therapies within 4 weeks before treatment with APC-100 * Evidence of active second malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.