An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | May 2016 |
| End Date: | March 2020 |
| Contact: | Incyte Corporation Call Center |
| Phone: | 1.855.463.3463 |
A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies
This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with
advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose
escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on
maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose
expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the
selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly
differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of
INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in
combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability,
efficacy, PK, and PD of the selected combination dose(s) in Part 3.
advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose
escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on
maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose
expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the
selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly
differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of
INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in
combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability,
efficacy, PK, and PD of the selected combination dose(s) in Part 3.
Inclusion Criteria:
- Male or female subjects, age 18 years or older.
- Presence of measurable disease that has been confirmed by histology or cytology.
- Must not be a candidate for potentially curative therapy or standard-of-care approved
therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Exclusion Criteria:
- Receipt of anticancer medications, anticancer therapies, or investigational drugs
within the defined interval before the first administration of study drug.
- Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for stable
chronic toxicities (≤ Grade 2) not expected to resolve.
- Laboratory and medical history parameters outside Protocol-defined range.
- Known additional malignancy that is progressing or requires active treatment.
We found this trial at
11
sites
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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