Study of INCB053914 in Subjects With Advanced Malignancies

Conditions

• Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• INCB053914 — DRUG
  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.
• I-DAC (Intermediate dose cytarabine) — DRUG
  Cytarabine dose will be 1 g/m\^2. Cytarabine will be administered as an intravenous (IV) infusion.
• Azacitidine — DRUG
  Azacitidine dose will be 75 mg/m\^2. Azacitidine will be administered either sub-cutaneously (SC) or intravenously (IV).
• Ruxolitinib — DRUG
  Starting dose of ruxolitinib will be the dose the subject was on at study entry Ruxolitinib will be administered by mouth.

Study Details

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).

Key Dates

Start date

Dec 29, 2015

Status verified

Nov 2021

Primary completion

Aug 11, 2020

Completion

Aug 11, 2020

Study Design

Enrollment

97 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Parts 1 and 2: INCB053914 100 mg QD
  INCB053914 will be self-administered orally once a day in as a 100mg immediate release tablet as a monotherapy.
• Experimental: Parts 3 and 4: INCB053914 + Azacitidine
  Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.
• Experimental: Parts 3 and 4: INCB053914 + I-DAC (Intermediate dose cytarabine)
  I-DAC (intermediate dose cytarabine) will be administered at a dose of 1 g/m2 per day as an infusion as a combination therapy with INCB053914.
• Experimental: Parts 3 and 4: INCB053914 + Ruxolitinib
  Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
• Experimental: Parts 1 and 2: INCB053914 50 mg
  INCB053914 will be self-administered orally twice day in as a 50mg immediate release tablet as a monotherapy.
• Experimental: Parts 1 and 2: INB053914 65 mg
  INCB053914 will be self-administered orally twice day in as a 65mg immediate release tablet as a monotherapy.
• Experimental: Parts 1 and 2: INB053914 80 mg
  INCB053914 will be self-administered orally twice day in as a 80mg immediate release tablet as a monotherapy.
• Experimental: Parts 1 and 2: INB053914 100 mg BID
  INCB053914 will be self-administered orally twice day in as a 100mg immediate release tablet as a monotherapy.
• Experimental: Parts 1 and 2: INB053914 115 mg
  INCB053914 will be self-administered orally twice day in as a 115mg immediate release tablet as a monotherapy.

Primary Outcome Measure

Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events [ Time Frame: Approximately 7 months ]

Locations (19)

Find similar trials in Tucson, AZ

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