Brief Title
Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
Official Title
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)
Brief Summary
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).
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Determination of the maximum tolerated dose of Pemigatinib as a monotherapy and in combination as measured by the number of participants with adverse events
Secondary Outcome
Preliminary efficacy as assessed by Overall Response Rate (ORR) of Pemigatinib as monotherapy and in combination in subjects with measurable disease
Condition
Lung Cancer
Intervention
Pemigatinib
Study Arms / Comparison Groups
Dose Escalation
Description: Open-label dose escalation with an accelerated titration design based on observing each dose level for a period of 21 days. Dose Expansion Combination therapy: Gemcitabine + Cisplatin + Pemigatinib Pembrolizumab + Pemigatinib Docetaxel + Pemigatinib Trastuzumab + Pemigatinib INCMGA00012 + Pemigatinib
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
325
Start Date
January 31, 2015
Completion Date
December 31, 2020
Primary Completion Date
July 31, 2020
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Luis Féliz, MD, 1-855-463-3463,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT02393248
Organization ID
INCB 54828-101
Responsible Party
Sponsor
Study Sponsor
Incyte Corporation
Study Sponsor
Luis Féliz, MD, Study Director, Incyte Corporation
Verification Date
March 2020