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Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

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ClinicalTrials.gov Identifier: NCT03773302
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
QED Therapeutics, Inc.

Brief Summary:
Infigratinib is an oral medication which selectively binds to fibroblast grown factor receptor (FGFR)-2 and is being developed to treat participants with FGFR-2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral Infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR-2 gene fusions/translocations.

Condition or disease Intervention/treatment Phase
Advanced Cholangiocarcinoma FGFR2 Gene Mutation Drug: BGJ398 Drug: Gemcitabine Drug: Cisplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, Open Label, Randomized, Controlled Phase 3
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2022


Arm Intervention/treatment
Experimental: Infigratinib (BGJ398) 125 mg
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib
Drug: BGJ398
Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
Other Name: Infigratinib

Active Comparator: Gemcitabine + Cisplatin
Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
Drug: Gemcitabine
Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle

Drug: Cisplatin
Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle




Primary Outcome Measures :
  1. Number of participants with progression-free survival (Central Imaging Assessment) [ Time Frame: Month 12 ]
    Defined as the time from randomization until date of disease progression by central independent imaging assessment (Response Evaluation Criteria in Solid Tumors [RECIST] v. 1.1) or death, whichever occurs first.


Secondary Outcome Measures :
  1. Percentage of overall survival in participants treated with infigratinib versus gemcitabine with cisplatin [ Time Frame: Month 12 ]
    Defined as time from date of randomization until death due to any cause

  2. Percentage of investigator assessed progression free survival in participants treated with infigratinib compared to gemcitabine and cisplatin [ Time Frame: Month 12 ]
    Defined as the time from randomization until date of disease progression by site investigator (RECIST v1.1) or death, whichever occurs first.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed non-resectable, recurrent or metastatic cholangiocarcinoma. Participants with gallbladder cancer or ampulla of Vater carcinoma are not eligible
  • Documented FGFR-2 gene fusions/translocations
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Able to swallow and retain oral medication
  • Willingness to avoid pregnancy or father children

Exclusion Criteria:

  • Received treatment with any systemic anti-cancer therapy for unresectable, recurrent, or metastatic cholangiocarcinoma. Prior neoadjuvant or adjuvant therapy is permitted if completed > 6 months prior to first dose of study drug.
  • History of a liver transplant
  • Received prior or current treatment with a mitogen activated protein kinase kinase (MEK) or selective FGFR inhibitor
  • Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection.
  • Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc.
  • History and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification
  • Current evidence of corneal or retinal disorder/keratopathy
  • Receiving and continued treatment with agents or consuming foods that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration
  • Receiving and continued treatment with therapeutic doses of certain anticoagulants that are primarily metabolized by CYP3A4. (Alternative medications that are not metabolized by CYP3A4 (e.g., dabigatran, edoxaban) are allowed)
  • Clinically significant or uncontrolled cardiac disease
  • Recent (≤ 3 months prior to first dose of study drug) transient ischemic attack or stroke
  • Severe hearing loss
  • Severe neuropathy
  • History of another primary malignancy within 3 years except adequately treated in-situ carcinoma of the cervix or non-melanoma skin cancer or other curatively treated malignancy that is not expected to require treatment
  • Pregnant or breastfeeding
  • Have known microsatellite instability-high (MSI-H) disease and the decision is made by the treating investigator that an alternative, non-study therapy is warranted according to standard of care.

Information from the National Library of Medicine

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): NCT03773302


Contacts
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Contact: QED Therapeutics VP Clinical Development 650-231-4088 PROOFTrialInfo@QEDTx.com
Contact: QED Therapeutics Chief Medical Officer PROOFTrialInfo@QEDTx.com

Locations
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United States, Kentucky
QED Investigative Site Not yet recruiting
Louisville, Kentucky, United States, 40202
United States, Maryland
QED Investigative Site Not yet recruiting
Frederick, Maryland, United States, 21702
United States, Michigan
QED Investigative Site Not yet recruiting
Detroit, Michigan, United States, 48201
QED Investigative Site Recruiting
Grand Rapids, Michigan, United States, 49503
United States, New York
QED Investigative Site Recruiting
Bronx, New York, United States, 10469
United States, Ohio
QED Investigative Site Not yet recruiting
Columbus, Ohio, United States, 43202
United States, South Carolina
QED Investigative Site Recruiting
Charleston, South Carolina, United States, 29414
Sponsors and Collaborators
QED Therapeutics, Inc.
Investigators
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Study Director: VP Clinical Development QED Therapeutics

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Responsible Party: QED Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03773302     History of Changes
Other Study ID Numbers: QBGJ398-301
2018-004004-19 ( EudraCT Number )
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by QED Therapeutics, Inc.:
cholangiocarcinoma
unresectable cholangiocarcinoma
metastatic cholangiocarcinoma
fibroblast growth factor receptor inhibitor
FGFR2
FGFR2 gene fusions/translocations
BGJ398
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs