Pemigatinib in the Advanced Gastrointestinal Cancer With FGFR 1-3 Alterations

NCT05651672 | Recruiting Phase 2

• 1 other identifier: TJ-0046
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective single-arm phase II study to evaluate the efficacy and safety of Pemigatinib in the advanced gastrointestinal cancer with FGFR 1-3 alterations and failed standard therapy.

Conditions

Gastrointestinal Cancer

Keywords

Gastrointestinal Cancer; Pemigatinib

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Defined as proportion of patients who have a best response of complete response (CR) + partial response (PR) according to the RECIST 1.1 criteria

  up to 2 years

Secondary Outcomes (5)

• Progress Free Survival (PFS)

  Up to 4 years

• Overall Survival (OS)

  Up to 4 years

• Duration of Response (DOR)

  up to 4 years

• Disease Control Rate (DCR)

  Up to 2 years

• Adverse Events (AEs)

  Up to 2 years

Study Arms (1)

experimental group

EXPERIMENTAL

Pemigatinib

Drug: Pemigatinib

Interventions

Pemigatinib DRUG

13.5mg, po, 2 weeks on/1 week off, Q3W

Also known as: Pemazyre

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or older
• Histologically or cytologically confirmed unresectable advanced, recurrent or metastatic gastrointestinal cancer
• Have at least one measurable lesion according to RECIST v1.1
• With histologically confirmed FGFR1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement
• Disease progression after prior standard therapy
• No previous use of small molecule multi-target inhibitors targeting the FGFR pathway (including but not limited to anlotinib, lenvatinib, sorafenib, apatinib)
• ECOG performance status of 0\~1
• Expected survival time \> 3 months
• Sufficient organ functions
• Negative pregnancy test results of childbearing age women
• Patients at risk of conception (including their partners) need to use contraception

You may not qualify if:

• Diagnosed with malignant tumors other than gastrointestinal cancer within 5 years before the first dose, excluding radically cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ
• Prior receipt of selective FGFR inhibitors
• Have received any other investigational drug or participated in another interventional clinical trial within 28 days before the first dose, or have received anti-tumor drug treatment within 28 days before the first dose (including Chinese herbal medicine with anti-tumor indications)
• Have not recovered ( ≤ grade 1 or reaching the baseline, excluding asthenia and alopecia) from toxicity and/or complications caused by any intervention before the start of treatment
• Known symptomatic central nervous system metastasis and/or carcinomatous meningitis.
• Known history of allotransplantation or allogeneic hematopoietic stem cell transplantation
• Abnormal laboratory parameters listed below:
• Serum phosphate \> upper limit of normal (ULN)
• Serum calcium exceeds the normal range, or the calcium concentration corrected for serum albumin exceeds the normal range when serum albumin exceeds the normal range
• Potassium level \< lower limit of normal (LLN)#potassium levels can be corrected by supplements at screening
• Known history of human immunodeficiency virus (HIV) infection or confirmed with positive immune test results
• Presence of severe infection in the active phase or with poor clinical control
• Pleural effusion, ascites, or pericardial effusion with obvious clinical symptoms that require drainage
• Acute or chronic active hepatitis B or C infection
• Clinically significant or uncontrolled heart diseases, including unstable angina, acute myocardial infarction within 6 months before the first dose, grade III/IV congestive heart failure (New York Heart Association), and uncontrolled arrhythmia (patients with pacemakers or with atrial fibrillation but well controlled heart rate are allowed)

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

pemigatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Wei Lu

CONTACT

+86-22-23340123; mail4luwei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: December 2, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

CN (1)