Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
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ClinicalTrials.gov Identifier: NCT04003623 |
Recruitment Status :
Terminated
(The study was closed due to lack of enrollment.)
First Posted : July 1, 2019
Results First Posted : April 21, 2022
Last Update Posted : May 10, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced or Metastatic Solid Tumors FGFR Mutations FGFR Translocations | Drug: Pemigatinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Participants will be assigned to 1 of 2 cohorts (Cohort A: FGFR1-3 in-frame fusions or FGFR2 intron 17 rearrangements; Cohort B: Known/predicted activating point mutations in FGFR1-3 [excluding kinase domain]) but there is no difference in the treatment regimen between the cohorts. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumors Harboring Activating FGFR Mutations or Translocations (FIGHT-208) |
Actual Study Start Date : | October 31, 2019 |
Actual Primary Completion Date : | June 12, 2020 |
Actual Study Completion Date : | June 12, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Pemigatinib |
Drug: Pemigatinib
Pemigatinib administered orally once daily.
Other Name: INCB054828 |
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 6 months ]Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- Progression-free Survival (PFS) [ Time Frame: Up to approximately 6 months ]Defined as the time from first dose until progressive disease (per RECIST v1.1 or Response Assessment in Neuro-Oncology [RANO]) or death (whichever is first) in each cohort.
- Duration of Response (DOR) [ Time Frame: Up to approximately 6 months ]Defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (per RECIST v1.1 or RANO) or death (whichever is first) in each cohort.
- Disease Control Rate (DCR) [ Time Frame: Up to approximately 6 months ]Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease per RECIST v1.1 or RANO.
- Overall Survival (OS) [ Time Frame: Up to approximately 6 months ]Defined as the time from first dose of study drug to death of any cause in each cohort.
- Number of Treatment-related Adverse Events [ Time Frame: Up to approximately 6 months ]Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV) or is surgically unresectable.
- Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors).
- Documentation of an FGFR1-3 gene mutation or translocation.
- Objective disease progression after at least 1 prior therapy.
- Not eligible or able to participate in any other Incyte-sponsored clinical trial.
Exclusion Criteria:
- Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.
- Prior receipt of a selective FGFR inhibitor.
- Current evidence of clinically significant corneal or retinal disorder.
- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.

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): NCT04003623
United States, California | |
Compassionate Cancer Care Medical Group | |
Fountain Valley, California, United States, 92708 | |
United States, Florida | |
Ocala Oncology Center | |
Ocala, Florida, United States, 34474 | |
United States, Hawaii | |
Hawaii Cancer Care | |
Honolulu, Hawaii, United States, 96813 | |
United States, Illinois | |
Illinois Cancer Care | |
Peoria, Illinois, United States, 61615 | |
United States, Maryland | |
FMH James M Stockman Cancer Institute | |
Frederick, Maryland, United States, 21702 | |
United States, New Jersey | |
New Jersey Cancer Care and Blood Disorders | |
Belleville, New Jersey, United States, 07109 | |
United States, Ohio | |
TriHealth | |
Cincinnati, Ohio, United States, 45220 | |
United States, South Dakota | |
Sanford Cancer Center | |
Sioux Falls, South Dakota, United States, 51704 | |
United States, Texas | |
Mary Crowley Cancer Center | |
Dallas, Texas, United States, 75230 | |
Oncology Consultants | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Utah Cancer Specialists | |
Salt Lake City, Utah, United States, 84106 |
Study Director: | Incyte Medical Monitor | Incyte Corporation |
Documents provided by Incyte Corporation:
Responsible Party: | Incyte Corporation |
ClinicalTrials.gov Identifier: | NCT04003623 |
Other Study ID Numbers: |
INCB 54828-MA-TA-208 |
First Posted: | July 1, 2019 Key Record Dates |
Results First Posted: | April 21, 2022 |
Last Update Posted: | May 10, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications. |
Access Criteria: | Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement. |
URL: | https://www.incyte.com/our-company/compliance-and-transparency |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Advanced solid tumor metastatic solid tumor FGFR inhibitor FGFR mutation FGFR translocation |
Neoplasms |