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).

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

69

Study ID:

NCT02431260

Recruitment Status:

Terminated

Sponsor:

Incyte Corporation

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There are 12 Locations for this study

See Locations Near You

Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
University of California, San Francisco, Medical Center at Mount Zion
San Francisco California, 94115, United States
Sarah Cannon Research Institute Research Center
Denver Colorado, 80218, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
Horizon Oncology Center
Lafayette Indiana, 47905, United States
John Hopkins
Baltimore Maryland, 21287, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Washington University School of Medicine in St. Louis
Saint Louis Missouri, 63110, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

69

Study ID:

NCT02431260

Recruitment Status:

Terminated

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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