Clinical Trial Details
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NCT02711137 : A Phase 1/2, Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of advanced malignancy:

- Part 1: advanced solid tumor or hematologic malignancy

- Part 2: histologically confirmed disease in specific tumor types

- Progressed following at least 1 line of prior therapy and there is no further
established therapy that is known to provide clinical benefit (including subjects who
are intolerant to the established therapy)

- Life expectancy > 12 weeks

- Eastern Cooperative Oncology Group (ECOG) performance status

- Part 1: 0 or 1

- Part 2: 0, 1, or 2

- Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

- Inadequate bone marrow function per protocol-specified hemoglobin, platelet count,
and absolute neutrophil count

- Inadequate organ function per protocol-specified total bilirubin, AST and ALT, and
creatinine clearance

- Receipt of anticancer medications or investigational drugs within protocol-specified

- Unless approved by the medical monitor, may not have received an allogeneic
hematopoietic stem cell transplant within 6 months before treatment, or have active
graft-versus-host-disease following allogeneic transplant

- Unless approved by the medical monitor, may not have received autologous
hematopoietic stem cell transplant within 3 months before treatment

- Any unresolved toxicity ? Grade 2 (except stable Grade 2 peripheral neuropathy or
alopecia) from previous anticancer therapy

- Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation
treatment to nonindex or bone lesions performed less than 2 weeks before treatment
initiation may be considered with medical monitor approval

- Currently active and uncontrolled infectious disease requiring systemic antibiotic,
antifungal, or antiviral treatment

- Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases
that have progressed

- History or presence of abnormal electrocardiogram (ECG) that, in the investigator's
opinion, is clinically meaningful
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