A Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03235570|
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: Pemigatinib||Phase 1|
|Study Type :||Interventional|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Dose-Escalation, Dose-Expansion, Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||June 13, 2020|
|Estimated Study Completion Date :||October 13, 2020|
Part 1 is an open-label dose-escalation design based on observing each dose level for a period of 21 days. Part 2 will evaluate the recommended dose determined in Part 1.
Pemigatinib at the protocol-defined dose administered once daily.
Other Name: INCB054828
- Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) [ Time Frame: Baseline through 30 days after end of treatment, up to approximately 16 months. ]An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.
- Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Baseline and Day 15 of every third treatment cycle, up to approximately 6 months ]Defined as proportion of subjects who meet the response criteria (complete response + partial response) as appropriate for the tumor type.
- Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level [ Time Frame: Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months ]Analyzed to look for differences that may be associated with response or safety as well as significant changes associated with treatment.
- Observed Plasma Concentration of pemigatinib [ Time Frame: During the first cycle, up to Day 16 ]PK parameters will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental (model independent) PK methods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235570
|Contact: Incyte Corporation Call Center (ex-US)||+800 email@example.com|
|Aichi Cancer Center Hospital||Recruiting|
|Aichi, Japan, 464-8681|
|Contact: Study Coordinator +81-052-762-6111|
|Chiba Cancer Center||Recruiting|
|Chiba, Japan, 260-8717|
|Contact: Study Coordinator +81-043-264-5431|
|National Cancer Central Hospital East||Recruiting|
|Chiba, Japan, 277-8577|
|Contact: Study Coordinator +81-04-7133-1111|
|Kanagawa Cancer Center||Recruiting|
|Kanagawa, Japan, 241-8515|
|Contact: Study Coordinator +81-045-520-2222|
|Osaka International Cancer Institute||Recruiting|
|Osaka, Japan, 541-8567|
|Contact: Study Coordinator +81-06-6945-1181|
|Saitama Cancer Center||Recruiting|
|Saitama, Japan, 362-0806|
|Contact: Study Coordinator +81-048-722-1111|
|Hokkaido Cancer Center||Recruiting|
|Sapporo, Japan, 003-0804|
|Contact: Study Coordinator +81-011-811-9111|
|Shizuoka Cancer Center||Recruiting|
|Shizuoka, Japan, 411-8777|
|Contact: Study Coordinator +81-55-989-5222|
|National Cancer Central Hospital||Recruiting|
|Tokyo, Japan, 104-0045|
|Contact: Study Coordinator +81-03-3542-2511|
|JFCR Ariake Hospital||Recruiting|
|Tokyo, Japan, 135-8550|
|Contact: Study Coordinator +81-03-3520-0111|
|Study Director:||Ekaterine Asatiani, MD||Incyte Corporation|