NCT02587598

Study of INCB053914 in Subjects With Advanced Malignancies

A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of INCB053914 in combination with select standard of care (SOC) agents and will identify the optimal INCB053914 dose in combination with conventional SOC regimens to take forward into Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and pharmacokinetics of the recommended Phase 2 dose combination(s).

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	INCB053914	Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria. INCB053914 tablets to be administered by mouth.
DRUG	I-DAC (Intermediate dose cytarabine)	Cytarabine dose will be 1 g/m\^2. Cytarabine will be administered as an intravenous (IV) infusion.
DRUG	Azacitidine	Azacitidine dose will be 75 mg/m\^2. Azacitidine will be administered either sub-cutaneously (SC) or intravenously (IV).
DRUG	Ruxolitinib	Starting dose of ruxolitinib will be the dose the subject was on at study entry Ruxolitinib will be administered by mouth.

Timeline

• Start date: 2015-12-29
• Primary completion: 2020-08-11
• Completion: 2020-08-11
• First posted: 2015-10-27
• Last updated: 2021-12-08
• Results posted: 2021-12-08

Locations

19 sites across 1 country: United States