Breast Cancer Clinical Trial
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
Summary
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).
Eligibility 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
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There are 12 Locations for this study
Los Angeles California, 90048, United States
San Francisco California, 94115, United States
Denver Colorado, 80218, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Lafayette Indiana, 47905, United States
Baltimore Maryland, 21287, United States
Ann Arbor Michigan, 48109, United States
Saint Louis Missouri, 63110, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
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