Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Cervical Cancer, Liver Cancer, Cancer, Blood Cancer, Hematology, Hematology, Endometrial Cancer
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:January 2015
End Date:January 2020
Contact:Incyte Call Center
Phone:1-855-463-3463

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A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)

The purpose of this study will be to evaluate the safety, tolerability, and pharmacological
activity of pemigatinib in subjects with advanced malignancies. This study will have three
parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).


Inclusion Criteria:

1. Male or female subjects, age 18 years or older on day of signing consent

2. Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small
cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer,
breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy
that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR
genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor
(FGFR) alteration may be based on local or central laboratory results. Part 3: Dose
finding: subjects with solid tumor malignancies who qualify for combo therapy;
dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy

3. Has progressed after prior therapy and there is no further effective standard
anticancer therapy available (including subject refuses or is intolerant)

4. Life expectancy > 12 weeks

5. Eastern Cooperative Oncology Group (ECOG) performance status:

- Part 1: 0 or 1

- Part 2 and 3: 0, 1, or 2

Exclusion Criteria:

1. Treatment with other investigational study drug for any indication for any reason, or
receipt of anticancer medications within 21 days or 5 half-lives before first dose of
study drug

2. Prior receipt of a selective FGFR inhibitor

3. History of a calcium/phosphate homeostasis disorder

4. History and/or current evidence of ectopic mineralization/calcification

5. Current evidence of corneal disorder/keratopathy

6. Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac
function parameters outside protocol-defined range

7. Prior radiotherapy within 2 weeks of study treatment
We found this trial at
16
sites
Houston, Texas 77030
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Ann Arbor, MI
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Columbus, OH
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9 Blegdamsvej
Copenhagen, 2100
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Copenhagen,
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Dallas, TX
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20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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Durham, NC
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Greenville, South Carolina 29615
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Greenville, SC
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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Los Angeles, California 90048
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Los Angeles, CA
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Middletown, OH
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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Saint Louis, Missouri 63110
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Saint Louis, MO
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San Antonio, TX
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Tuscaloosa, Alabama 35401
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Tuscaloosa, AL
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Washington, District of Columbia 20007
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Washington,
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