Klinische Studien

INCYTE - INCB 54828-207

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
Protocol INCB 54828-207

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 TUMOR MALIGNANCIES HARBORING ACTIVATING FGFR MUTATIONS OR TRANSLOCATIONS

Status: Active

Purpose / Objectives

Primary Outcome

To evaluate the efficacy of pemigatinib in participants with locally advanced/metastatic or surgically unresectable solid tumor malignancy with an activating FGFR mutation or translocation

Secondary Outcomes

 To evaluate other clinical efficacy measurements of pemigatinib in participants with locally advanced/metastatic or surgically unresectable solid tumor malignancy with an activating FGFR mutation and/or translocation
 Safety and tolerability of pemigatinib

Diagnosis

Solid tumor malignancy

Target population

Inclusion criteria

Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Age 18 years or older, inclusive at the time of signing the informed consent.
2. Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV per the American Joint Committee on Cancer, Cancer Staging Manual, 6th Edition) or is surgically unresectable.
3. Radiographically measurable or evaluable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measureable if progression has been clearly demonstrated in the lesion.
4. Documentation of an FGFR1-3 gene mutation or translocation. Subjects will be assigned to 1 of 3 cohorts:
o Cohort A: FGFR1-3 translocations
o Cohort B: Known/predicted activating point mutations in FGFR1-3 (excluding kinase domain)
o Cohort C: Any FGFR1-3 point mutations in the kinase domain and variants of unknown significance not included in Appendix C.
5. Received at least 1 line of prior therapy, and there is no further approved therapy and has had objective disease progression or is intolerant to previous therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including participants who are intolerant to the approved therapy) or the participant declines to receive standard of care for their type of tumor.
6. ECOG performance status 0 to 2.
7. Baseline archival tumor specimen (if less than 12 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis.
8. Willingness to avoid pregnancy or fathering children based on the criteria below.
a. Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last dose of study drug(s)/treatment and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
b. Women of childbearing potential must have a negative serum pregnancy test at screening and before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed

Exclusion criteria

1. Prior receipt of a selective FGFR inhibitor in the past 6 months
2. Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib. Participants must have recovered (≤ Grade 1, as per CTCAE v 5.0 or at pretreatment baseline) from adverse events (AEs) from previously administered therapies (excluding alopecia).
3. Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, etc.) or retinal disorder (including, but not limited to, macular/retinal degeneration, diabetic retinopathy, retinal detachment, etc.) as confirmed by ophthalmologic examination.

Study design

  • Phase II
  • Multicenter
  • One-arm
  • Open Label

Documents (password protected)

Responsibilities in overall study

Study Sites

Med. Klinik 5 Onkologie/Hämatologie - Klinikum Nürnberg

Address
Med. Klinik 5 Onkologie/Hämatologie - Klinikum Nürnberg
Klinikum Nürnberg Nord
Prof.-Ernst-Nathan-Str. 1
90419 Nürnberg
Haus: Bau 12

Status

Active

Principal Investigator

Dr. med. Gabriele Siegler

Deputy of Principal Investigator

  • Dr. med. Marinela Augustin

Contact at Site

 
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