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Trial record 11 of 14 for:    BGJ398

A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT02150967
Recruitment Status : Recruiting
First Posted : May 30, 2014
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
QED Therapeutics, Inc.

Brief Summary:
This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with Fibroblast Growth Factor receptor (FGFR) genetic alterations.

Condition or disease Intervention/treatment Phase
Advanced Cholangiocarcinoma Drug: BGJ398 (infigratinib) Phase 2

Detailed Description:
Adult patients with histologically or cytologically confirmed advanced or metastatic cholangiocarcinoma with FGFR genetic alterations who have evidence of radiologic progression following a cisplatin-and gemcitabine-containing regimen for advanced disease or a gemcitabine-containing regimen for those who are considered intolerant to cisplatin will be enrolled. Approximately 55 adult patients over age 18, both male and female will be enrolled. Of these 55 patients, 40 patients will have cholangiocarcinoma with identified FGFR2 gene fusions and up to 15 patients may have other FGFR genetic alterations. All patients will receive oral BGJ398, once daily, on a three weeks on (21 days), one week off (7 days) schedule. One treatment cycle will consists of 28 days.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy
Actual Study Start Date : July 14, 2014
Estimated Primary Completion Date : October 18, 2019
Estimated Study Completion Date : October 18, 2019


Arm Intervention/treatment
Experimental: BGJ398 (infigratinib)
To estimate anti-tumor activity of BGJ398
Drug: BGJ398 (infigratinib)
Capsule for oral use




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: up to 24 months ]
    Overall response rate (ORR) is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR), as per RECIST version 1.1.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 24 months ]
    Overall Survival (OS) is defined as the time from the date of start of treatment to the date of death due to any cause.

  2. Progression free survival [ Time Frame: up to 24 months ]
    Progression free survival (PFS) is defined as the date of the start of treatment to the date of the event defined as the first documented progression or death due to any cause.

  3. Best overall response [ Time Frame: up to 24 months ]
    The best overall response is the best response recorded from the start of the treatment until disease progression.

  4. Disease control rate [ Time Frame: up to 24 months ]
    Disease control rate (DCR) is the proportion of patients with a best overall response of CR or PR or stable disease (SD).

  5. Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability [ Time Frame: up to 24 months ]
    To characterize the safety and tolerability of single agent BGJ398 by the type, frequency and severity of AEs & SAEs.

  6. Selected trough and 2-hr Plasma concentration profile [ Time Frame: up to 12 months ]
    To determine selected trough and 2-hr plasma concentrations of BGJ398



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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:

- Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis.

Patients with cancers of the gallbladder or ampulla of Vater are not eligible.

- Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/ metastatic disease. Patient should have evidence of progressive disease following prior regimen, or if prior treatment discontinued due to toxicity must have continued evidence of measurable or evaluable disease.

Exclusion criteria:

  • Prior or current treatment with a MEK or selective FGFR inhibitor
  • insufficient organ function

    • Absolutely Neutrophil Count (ANC) < 1,000/mm3 [1.0 x 109/L]
    • Platelets < 75,000/mm3 [75 x 109/L]
    • Hemoglobin < 109.0 g/dL
    • Total bilirubin > 1.5x ULN
    • Aspartate aminotransferase/glutamic oxaloacetic transaminase/GOT (AST/SGOT) and Alanine aminotransferase/glutamic pyruvic transaminase/GPT (ALT/SGPT) > 2.5x ULN (AST and ALT) > 5x upper limit of normal (ULN) in the presence of liver metastases)
    • Serum creatinine > 1.5x ULN and a calculated or measured creatinine clearance < 45 mL/min
    • Inorganic phosphorus outside of normal limits
    • Total and ionized serum calcium outside of normal limits

Other protocol-defined inclusion/exclusion criteria may apply.


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): NCT02150967


Contacts
Contact: QED Therapeutics 650-231-4088 clinicaltrials@QEDTx.com
Contact: QED Therapeutics clinicaltrials@QEDTx.com

  Show 30 Study Locations
Sponsors and Collaborators
QED Therapeutics, Inc.
Investigators
Study Director: QED Therapeutics QED Therapeutics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: QED Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02150967     History of Changes
Other Study ID Numbers: CBGJ398X2204
2013-005085-19 ( EudraCT Number )
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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,
FGFR2 gene fusion,
FGFR genetic alteration

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms