Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 4:11 AM
Study NCT ID:
NCT02150967
Status:
TERMINATED
Last Update Posted:
2023-07-03
First Post:
2014-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
Sponsor:
QED Therapeutics, a BridgeBio company
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early due to limited efficacy in Cohorts 2 and 3 (exploratory endpoints). Termination was not due to concerns about safety and had no impact on the primary efficacy analysis (ie, results reported for Cohort 1).
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center, open label, single arm phase II study evaluating BGJ398 (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with fibroblast growth factor receptor (FGFR) genetic alterations.
Detailed Description:
Adult patients with histologically or cytologically confirmed advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or translocations or other FGFR genetic alterations have been enrolled. Subjects must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/metastatic disease. Subjects should have had evidence of progressive disease following their prior regimen or if prior treatment was discontinued due to toxicity must have continued evidence of measurable disease. Up to approximately 160 adult patients over age 18, both male and female were planned for enrollment.
Three cohorts of subjects comprise the study population:
Cohort 1: subjects with FGFR2 gene fusions (ie, fusions or rearrangements \[formerly translocations\]).
Cohort 2: subjects with FGFR genetic alterations other than FGFR2 gene fusions or rearrangements.
Cohort 3: subjects with FGFR2 gene fusions or rearrangements who have received a prior FGFR inhibitor.
All subjects received oral BGJ398 (infigratinib), once-daily, on a three weeks on (21 days), one week off (7 days) schedule. One treatment cycle consists of 28 days.
Notes:
Cohort 1 was pre-specified as the primary analysis population. Results of these analyses were previously disclosed (posted 22 June 2022). There were no additional efficacy or safety endpoints to assess in Cohort 1 after primary completion (01 March 2021).
Cohorts 2 and 3 were added at protocol amendment (PA) 4 to support only exploratory efficacy objectives of the study. These cohorts were ongoing the time of primary completion (01 March 2021). After interim review of the data from these cohorts (as permitted by the protocol) only limited efficacy was observed and the sponsor terminated the study early. Therefore, a formal efficacy analysis was not performed for Cohorts 2 and 3. However, baseline characteristics and safety data were analyzed.
Three cohorts of subjects comprise the study population:
Cohort 1: subjects with FGFR2 gene fusions (ie, fusions or rearrangements \[formerly translocations\]).
Cohort 2: subjects with FGFR genetic alterations other than FGFR2 gene fusions or rearrangements.
Cohort 3: subjects with FGFR2 gene fusions or rearrangements who have received a prior FGFR inhibitor.
All subjects received oral BGJ398 (infigratinib), once-daily, on a three weeks on (21 days), one week off (7 days) schedule. One treatment cycle consists of 28 days.
Notes:
Cohort 1 was pre-specified as the primary analysis population. Results of these analyses were previously disclosed (posted 22 June 2022). There were no additional efficacy or safety endpoints to assess in Cohort 1 after primary completion (01 March 2021).
Cohorts 2 and 3 were added at protocol amendment (PA) 4 to support only exploratory efficacy objectives of the study. These cohorts were ongoing the time of primary completion (01 March 2021). After interim review of the data from these cohorts (as permitted by the protocol) only limited efficacy was observed and the sponsor terminated the study early. Therefore, a formal efficacy analysis was not performed for Cohorts 2 and 3. However, baseline characteristics and safety data were analyzed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-005085-19 | EUDRACT_NUMBER | None | View |