Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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.

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date April 29, 2019
Estimated Study Start Date  ICMJE April 2019
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03773302 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multicenter, Open Label, Randomized, Controlled Phase 3
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cholangiocarcinoma
  • FGFR2 Gene Mutation
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: BGJ398
  • Active Comparator: Gemcitabine + Cisplatin
    Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
    Interventions:
    • Drug: Gemcitabine
    • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2018)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2022
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: QED Therapeutics VP Clinical Development 650-231-4088 PROOFTrialInfo@QEDTx.com
Contact: QED Therapeutics Chief Medical Officer PROOFTrialInfo@QEDTx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773302
Other Study ID Numbers  ICMJE QBGJ398-301
2018-004004-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party QED Therapeutics, Inc.
Study Sponsor  ICMJE QED Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: VP Clinical Development QED Therapeutics
PRS Account QED Therapeutics, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP