Ovarian Cancer Clinical Trial

A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

Summary

The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
Presence of measurable disease per RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.
Resolution of treatment-related toxicities.
Adequate hepatic, renal, cardiac, and hematologic function.
Additional cohort-specific criteria may apply.

Exclusion Criteria:

Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
Has received prior approved radiotherapy within 14 days of study therapy.
Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has an active infection requiring systemic therapy.
Has known active CNS metastases and/or carcinomatous meningitis.
Women who are pregnant or breastfeeding.

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

149

Study ID:

NCT03314935

Recruitment Status:

Active, not recruiting

Sponsor:

Incyte Corporation

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There are 10 Locations for this study

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University of Alabama
Birmingham Alabama, 35294, United States
USA Mitchell Cancer Center
Mobile Alabama, 36604, United States
UC Davis - Comprehensive Cancer Centre
Sacramento California, 95817, United States
Northwest Georgia Oncology Centers
Marietta Georgia, 30060, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
START San Antonio
San Antonio Texas, 78229, United States
Grand Hopital de Charleroi - Department of Medical Oncology
Brussels , 6000, Belgium
Institut Jules Bordet - Clinical Trials Conduct Unit
Brussels , B-100, Belgium
UCL Cancer Institute
London , WC1E , United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

149

Study ID:

NCT03314935

Recruitment Status:

Active, not recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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