Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
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ClinicalTrials.gov Identifier: NCT02393248 |
Recruitment Status :
Recruiting
First Posted : March 19, 2015
Last Update Posted : October 28, 2020
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Condition or disease | Intervention/treatment | Phase |
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Lung Cancer Solid Tumor Gastric Cancer Urothelial Cancer Endometrial Cancer Multiple Myeloma Myeloproliferative Neoplasms Breast Cancer Cholangiocarcinoma UC MPN | Drug: Pemigatinib Drug: Gemcitabine + Cisplatin Drug: Pembrolizumab Drug: Docetaxel Drug: Trastuzumab Drug: INCMGA00012 | Phase 1 Phase 2 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 256 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101) |
Actual Study Start Date : | February 27, 2015 |
Estimated Primary Completion Date : | February 15, 2021 |
Estimated Study Completion Date : | May 25, 2021 |

Arm | Intervention/treatment |
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Experimental: Dose Escalation
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:
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Drug: Pemigatinib
Other Name: INCB054828 Drug: Gemcitabine + Cisplatin Drug: Pembrolizumab Drug: Docetaxel Drug: Trastuzumab Drug: INCMGA00012 |
- Determination of the maximum tolerated dose of Pemigatinib as a monotherapy and in combination as measured by the number of participants with adverse events [ Time Frame: from baseline through 21 days ]
- Assess the pharmacodynamics of pemigatinib as a monotherapy and in combination as indicated by serum phosphorus level [ Time Frame: up to 30 days (+ 5 days) follow-up visit ]
- Preliminary efficacy as assessed by Overall Response Rate (ORR) of Pemigatinib as monotherapy and in combination in subjects with measurable disease [ Time Frame: Day 15 of every third cycle (± 2 days) while subjects are on study ]Tumor response rates in those subjects with measurable disease as determined by investigator assessment of response using RECIST (Response Evaluation Criteria in Solid Tumor) criteria
- Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy and in combination [ Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15 ]The pharmacokinetic (PK) parameters of Cmax and Cmin will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.
- Minimum observed plasma concentration (Cmin) during the dosing interval of Pemigatinib as monotherapy and in combination [ Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15 ]The pharmacokinetic (PK) parameters of Cmax and Cmin will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.
- Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy and in combination [ Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15 ]The PK parameter of Tmax will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.
- Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy and in combination [ Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15 ]Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, calculated by the linear trapezoidal rule for increasing concentrations and the log trapezoidal rule for decreasing concentrations.
- Oral dose clearance (Cl/F) of Pemigatinib as monotherapy and in combination [ Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15 ]The PK parameter of Cl/F will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental PK methods.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects, age 18 years or older on day of signing consent
- 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
- Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
- Life expectancy > 12 weeks
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Eastern Cooperative Oncology Group (ECOG) performance status:
- Part 1: 0 or 1
- Part 2 and 3: 0, 1, or 2
Exclusion Criteria:
- 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
- Prior receipt of a selective FGFR inhibitor
- History of a calcium/phosphate homeostasis disorder
- History and/or current evidence of ectopic mineralization/calcification
- Current evidence of corneal disorder/keratopathy
- Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
- Prior radiotherapy within 2 weeks of study treatment

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): NCT02393248
Contact: Incyte Call Center | 1-855-463-3463 |

Study Director: | Luis Féliz, MD | Incyte Corporation |
Responsible Party: | Incyte Corporation |
ClinicalTrials.gov Identifier: | NCT02393248 |
Other Study ID Numbers: |
INCB 54828-101 |
First Posted: | March 19, 2015 Key Record Dates |
Last Update Posted: | October 28, 2020 |
Last Verified: | October 2020 |
alterations in FGF or FGFR squamous non-small cell lung cancer gastric cancer urothelial cancer |
endometrial cancer multiple myeloma MPN |
Multiple Myeloma Stomach Neoplasms Endometrial Neoplasms Cholangiocarcinoma Myeloproliferative Disorders Neoplasms by Site Neoplasms Neoplasms, Plasma Cell Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Diseases Adenocarcinoma Carcinoma |