A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynam… (NCT02637531) | Clinical Trial Compass
UnknownPhase 1
A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549
United States219 participantsStarted 2015-12
Plain-language summary
This dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IPI-549 monotherapy and IPI-549 in combination with nivolumab in subjects with advanced solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
All subjects must meet the following criteria for inclusion:
* ≥ 18 years of age
* Life expectancy of ≥ 3 months
* Histological or cytological evidence of advanced and/or metastatic carcinoma or melanoma , excluding sarcoma
* At least 1 measurable disease lesion as defined by RECIST 1.1
* Serum creatinine clearance ≥ 60 mL/min and serum creatinine ≤ 2.0 x the upper limit of normal (ULN) as determined by either of the following: Estimation as calculated by Cockcroft-Gault equation or Direct measurement by 24-hour urine collection
* Total bilirubin ≤ 1.5 x ULN (unless elevated due to Gilbert's syndrome)
* Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 x ULN (\<5x ULN if liver metastasis)
* Adequate hematological function, defined as absolute neutrophil count ≥1.5 x 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100 x 109/L
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (corresponds to Karnofsky Performance Status (KPS) ≥ 60%)
Subjects entering Part A, B, C, or D must also meet the following additional criterion:
• Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgement of the Investigator)
Subjects entering Part D, E, F or G must also meet the following additional criterion:
• Willing to undergo 1 pre-treatment and 1 on-treatment tumor biopsy
Subjects entering Part E must also meet the following additional criteria:
* Histological o…
What they're measuring
1
Part A/B/C: Dose Limiting Toxicities (DLT)
Timeframe: From date of initial dose until up to 28 days for IPI-549
2
Part D/E: Adverse Events (AE) and safety laboratory values
Timeframe: Number of patients with Clinically significant abnormal laboratory values and adverse events that are related to treatment from date of initial dose until 30 days after last dose of IPI-549 and 100 days after the last dose of Nivolumab