Prostate Cancer
Conditions
Brief summary
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.
Interventions
DRUGAPC-100
Daily oral, dose escalation, 28-day cycle(s)
Sponsors
Adamis Pharmaceuticals Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose | Within 12 weeks following treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma Pharmacokinetics (PK) profile of APC-100 | Pre-Dose, Cycle 1:Day 1, Cycle 2:Day 2,Pre-Dose on Day 1 of each additional cycle | Single dose and steady state pharmacokinetics of APC-100 by oral administration daily for 28 consecutive days on a 28-day cycle will be determined. The following PK parameters (half-life, Cmax, Tmax, AUC, CI, CIr and V) will be determined. |
| Assess number, types, and severity of toxicity and adverse events | 12 weeks | Assessment of incidence, severity, duration, causality and types of toxicity and adverse event severities assessed by NCI Common Toxicity Criteria (NCI CTC), version 4.0) |
| Assess preliminary evidence of anti-tumor activity through PSA response | pre-study, Cycle 1: Day 1 (unless prestudy was performed within 7 days of study entry), Cycle 2: Day 1, End of Treatment | Assessment of preliminary anti-tumor activity will be based on PSA response (absolute and percentage change compared to prestudy (baseline) and RECIST criteria, if the patient has measurable disease. |
Countries
United States
Outcome results
None listed