A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:December 10, 2018
End Date:August 12, 2021
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics,
pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced
solid tumors who have failed prior treatments.


Inclusion Criteria:

- Histologically confirmed advanced solid tumors with measurable lesions per RECIST v1.1
that are considered nonamenable to surgery or other curative treatments or procedures.
Tumor lesions located in a previously irradiated area, or in an area subjected to
other loco-regional therapy, are considered measurable if progression has been
demonstrated in the lesion.

- Must have disease progression after treatment with available therapies that are known
to confer clinical benefit or who are intolerant to or ineligible for standard
treatment. There is no limit to the number of prior treatment regimens.

- Eastern Cooperative Oncology Group performance status score of 0 or 1.

- Life expectancy > 12 weeks.

- Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

- Laboratory values not within the Protocol-defined range.

- Clinically significant cardiac disease.

- History or presence of an ECG that, in the investigator's opinion, is clinically
meaningful.

- Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases
that have progressed. Participants who have previously treated and clinically stable
brain or CNS metastases and have not required steroids for at least 7 days before
study treatment are eligible.

- Known additional malignancy that is progressing or requires active treatment.

- Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy and/or
complications from prior surgical intervention before starting study treatment.

- Treatment with anticancer medications or investigational drugs within protocol-defined
intervals before the first administration of study drug.

- Active infection requiring systemic therapy.

- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

- Known history of HIV (HIV 1/2 antibodies).

- Known hypersensitivity or severe reaction to any component of study drug or
formulation components.
We found this trial at
4
sites
Houston, Texas 77030
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Tampa, Florida 33612
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Tampa, FL
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