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Trial record 1 of 1 for:    CBGJ398X2204
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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 : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
QED Therapeutics, Inc.

Study Description
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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 FGFR2 Gene Mutation Drug: BGJ398 (infigratinib) Phase 2

Detailed Description:

Adult patients with histologically or cytologically confirmed advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or translocations or other 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. Up to approximately 160 adult patients over age 18, both male and female will be enrolled. Three cohorts of patients comprise the study population:

Cohort 1: ~120 patients, 108 with FGFR2 gene fusions or translocations and 12 with other FGFR genetic alterations enrolled under the original protocol and amendment 1.

Cohort 2: ~20 patients with FGFR genetic alterations other than FGFR2 gene fusions or translocations.

Cohort 3: Up to ~20 patients with FGFR2 gene fusions or translocations who have received a prior FGFR inhibitor.

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 : March 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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


Outcome Measures
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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 will be summarized by the proportion of patients having a best overall response of PR, CR, stable disease (SD) or PD.

  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 or 4-hr Plasma concentration profile [ Time Frame: up to 12 months ]
    To determine selected trough and 2-hr or 4-hr plasma concentrations of BGJ398


Eligibility Criteria
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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 inhibitor (all cohorts), BGJ398/infigratinib (all cohorts), or selective FGFR inhibitor (Cohorts 1 and 2 only).

  • 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.

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

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Sponsors and Collaborators
QED Therapeutics, Inc.
Investigators
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Study Director: QED Therapeutics QED Therapeutics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: July 23, 2019
Last Verified: July 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,
FGFR2 gene fusion,
FGFR genetic alteration

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