Expired Study
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Lafayette, Indiana 47905


Purpose:

This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).


Criteria:

Key Inclusion Criteria: - Confirmed diagnosis of advanced malignancy: - Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma; Part 3: Histologically confirmed disease in specific solid tumors and lymphomas - Treatment Group B (TGB): Acute Leukemia (Part 3 - acute myeloid leukemia [AML] only), myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative neoplasms (MDS/MPN) and myelofibrosis (MF) - Treatment Group C (TGC): Multiple myeloma - Progressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in Parts 1 and 2 dose escalation and titration, and 0, 1, 2 in Part 3 dose expansion Key Exclusion Criteria: - Inadequate hematopoietic, liver, endocrine or renal function - Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug: - < 6 weeks for mitomycin-C or nitrosoureas - < 5 half-lives or 14 days, whichever is longer, for any investigational agent (for any indication) - < 28 days for any antibodies or biological therapies - < 5 half-lives for all other anticancer medications, or sponsor approval - Prior radiotherapy within 2 weeks prior to first dose of study drug - Untreated brain or central nervous system (CNS) metastases - Type 1 diabetes or uncontrolled Type 2 diabetes - Any sign of clinically significant bleeding


NCT ID:

NCT02431260


Primary Contact:

Study Director
Fred Zheng, M.D.
Incyte Corporation


Backup Contact:

N/A


Location Contact:

Lafayette, Indiana 47905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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