Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1 (NCT02355535) | Clinical Trial Compass
CompletedPhase 1
Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1
United States48 participantsStarted 2015-02
Plain-language summary
This Phase I dose escalation study will evaluate Procaspase Activating Compound-1 (PAC-1), a small molecule that activates procaspase -3 to caspase-3, resulting in apoptosis of cancer cells, in patients with advanced malignancies. As of March 1, 2019, only patients with neuroendocrine tumors will be enrolled in Component 1 of this study. PAC-1 is taken orally on days 1-21 of a 28-day cycle. The maximum tolerated dose (MTD) of PAC-1 (5 dose levels) will be determined using a modified-Fibonacci dose-escalation 3+3 design. Treatment continues until disease progression, unacceptable toxicity, physician discretion, or patient refusal.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Male or female ≥ 18 years of age
✓. Diagnosis of advanced solid tumor or hematologic malignancy (limited to lymphoma) that has failed or become intolerant to standard therapy
✓. Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1, or lymphoma that fulfills the Deauville PET Criteria
✓. Has an ECOG PS of 0, 1, or 2
✓. Has total bilirubin \< 1.5 mg/dL, serum albumin \> 3.0 gm/dL, AST and ALT \< 1.5 ULN or \< 3 x ULN for subjects with known hepatic metastases
✓. Has serum creatinine \< 1.5 × ULN
✓. Has hemoglobin ≥ 10 g/dL, ANC ≥ 1.5 × 109/L, and platelet count ≥ 100 × 109/L
✓. Must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after capsule(s) administration
Exclusion criteria
✕. Had surgery within 4 weeks prior to study treatment except for minor procedures (hepatic biliary stent placement is allowed)
✕. Gliomas are excluded, as well as any history of brain metastases, seizures or underlying brain injury
✕. May not have received cytotoxic chemotherapy, targeted therapies, biologic response modifiers, chemotherapy, and hormonal therapy within the last 3 weeks, or nitrosureas within the last 6 weeks prior to study treatment.
✕. Has a history of blood clots, pulmonary embolism, or DVT unless controlled by anticoagulant treatment
✕. Has a history of an arterial thromboembolic event within the prior six months including CVA, TIA, MI, or unstable angina
✕. Has uncontrolled HIV or hepatitis B or C
✕. Has any clinically significant infection
✕. Has any other severe, uncontrolled medical condition, including uncontrolled DM or unstable CHF