18 and older, any sex, with Advanced Cholangiocarcinoma or FGFR2 Gene Mutation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (Central Imaging Assessment)Primary· From the time of randomization to end of treatment due to confirmed disease progression or death. Note: PFS is an event driven endpoint. Subjects without confirmed disease progression at the end of study were censored at their last valid tumor assessment.
Defined as the time from randomization until date of disease progression by blinded independent central imaging assessment (Response Evaluation Criteria in Solid Tumors \[RECIST\] v. 1.1) or death, whichever occurs first.
Group
Value
95% CI
Infigratinib (BGJ398) 125 mg
7.39
0.03 – 12.85
Gemcitabine + Cisplatin
8.02
0.03 – 12.88
Overall Survival (OS) in Participants Treated With Infigratinib Versus Gemcitabine With CisplatinSecondary· From the time of randomization to time of death. Note: OS is an event driven endpoint. Subjects who had not died (no record of death) or were lost to follow-up were censored at the date of last known to be alive.
OS by investigator assessment, defined as time from date of randomization until death due to any cause
Group
Value
95% CI
Infigratinib (BGJ398) 125 mg
NA
14.36 – NA
Gemcitabine + Cisplatin
NA
8.02 – NA
Investigator Assessed Progression Free Survival in Participants Treated With Infigratinib Compared to Gemcitabine and CisplatinSecondary· From the time of randomization to end of treatment due to confirmed disease progression or death. Note: PFS is an event driven endpoint. Subjects without confirmed disease progression at the end of study were censored at their last valid tumor assessment.
Defined as the time from randomization until date of disease progression by site investigator (RECIST v1.1) or death, whichever occurs first.
Group
Value
95% CI
Infigratinib (BGJ398) 125 mg
7.39
0.03 – 20.24
Gemcitabine + Cisplatin
5.19
0.03 – 12.88
Overall Response Rate (ORR) Determined by Blinded Independent Central (BICR) and Investigator AssessmentSecondary· From the time of randomization to end of study treatment (an average of approx.6.5 months [max: 23 months] for the infigratinib arm and approx. 4 months [max: 11-13 months] for the gemcitabine + cisplatin arm up to the time of termination of the study).
ORR is defined as the proportion of subjects with a best overall response (BOR) of either confirmed partial response (PR) or confirmed complete response (CR) as assessed by BICR and the investigator according to RECIST v1.1 among patients with measurable disease at baseline
Group
Value
95% CI
ORR By Central Assessment
11
ORR By Investigator Assessment
9
ORR by Central Assessment
3
ORR by Investigator Assessment
2
Best Overall Response (BOR) Determined by Blinded Independent Central Assessment and the Investigator.Secondary· From the time of randomization to end of study treatment (an average of approx.6.5 months [max: 23 months] for the infigratinib arm and approx. 4 months [max: 11-13 months] for the gemcitabine + cisplatin arm up to the time of termination of the study).
BOR was defined as the best response a subject ever achieved after study treatment prior to crossover and any subsequent anticancer therapy, complete response (CR) and partial response (PR) were claimed only if the criteria for each were met at a subsequent time point at least 4 weeks apart. In the case of stable disease (SD), measurements must have met the SD criteria at least once post-baseline no less than 6 weeks from the randomization date.
Confirmed complete response
Group
Value
95% CI
BOR By Central Assessment
0
BOR By Investigator Assessment
0
BOR by Central Assessment
0
BOR by Investigator Assessment
0
Confirmed partial response
Group
Value
95% CI
BOR By Central Assessment
11
BOR By Investigator Assessment
9
BOR by Central Assessment
3
BOR by Investigator Assessment
2
Stable disease
Group
Value
95% CI
BOR By Central Assessment
14
BOR By Investigator Assessment
19
BOR by Central Assessment
11
BOR by Investigator Assessment
12
Progressive disease
Group
Value
95% CI
BOR By Central Assessment
2
BOR By Investigator Assessment
0
BOR by Central Assessment
2
BOR by Investigator Assessment
3
Not done
Group
Value
95% CI
BOR By Central Assessment
2
BOR By Investigator Assessment
1
BOR by Central Assessment
3
BOR by Investigator Assessment
2
Duration of Response (DOR) Determined by Blinded Independent Central Assessment and the Investigator.Secondary· From the time of randomization to end of study treatment (an average of approx.6.5 months [max: 23 months] for the infigratinib arm and approx. 4 months [max: 11-13 months] for the gemcitabine + cisplatin arm up to the time of termination of the study).
DOR is defined as the time from initiation of confirmed partial response (PR) or confirmed complete response (CR) to the time of confirmed progressive disease (PD) or death. If subjects do not reach PD or death before crossover, the DOR is censored at the last valid tumor assessment before crossover.
Group
Value
95% CI
DOR By Central Assessment
5.59
3.71 – NA
DOR By Investigator Assessment
7.52
3.71 – NA
DOR by Central Assessment
NA
3.94 – NA
DOR by Investigator Assessment
NA
8.08 – NA
Disease Control Rate (DCR=PR+CR+SD) Determined by Blinded Independent Central Assessment and the Investigator.Secondary· From the time of randomization to end of study treatment (an average of approx.6.5 months [max: 23 months] for the infigratinib arm and approx. 4 months [max: 11-13 months] for the gemcitabine + cisplatin arm up to the time of termination of the study).
DCR is defined as the proportion of subjects with a best overall response (BOR) of either confirmed partial response (PR), confirmed complete response (CR) or stable disease (SD) or non-CR/non-PD before crossover.
Group
Value
95% CI
DCR By Central Assessment
25
DCR By Investigator Assessment
28
DCR by Central Assessment
14
DCR by Investigator Assessment
14
Number of Participants With Adverse Events (AEs)Secondary· From baseline to last dose date of study treatment + 30 days (an average of 7.5 months for the infigratinib arm and 5 months for the gemcitabine + cisplatin arm).
Safety analyses were performed for subjects in the safety analysis population for each group. Unless otherwise specified, summaries were provided only for the on-treatment safety assessments, which are the assessments occurring or taken during the on-treatment period
Group
Value
95% CI
Infigratinib (BGJ398) 125 mg
29
Gemcitabine + Cisplatin
17
Number of Participants With Serious Adverse Events (SAEs)Secondary· From baseline to last dose date of study treatment + 30 days (an average of 7.5 months for the infigratinib arm and 5 months for the gemcitabine + cisplatin arm).
Safety analyses were performed for subjects in the safety analysis population for each group. Unless otherwise specified, summaries were provided only for the on-treatment safety assessments, which are the assessments occurring or taken during the on-treatment period
Group
Value
95% CI
Infigratinib (BGJ398) 125 mg
10
Gemcitabine + Cisplatin
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From the the time of the first administration of study treatment through 30 days after their last dose..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Infigratinib (BGJ398) 125 mg
Serious: 10/29 (34%)
Deaths: 0/29
Gemcitabine + Cisplatin
Serious: 0/17 (0%)
Deaths: 0/17
Serious adverse events (14 terms)
Reaction
System
Infigratinib (BGJ398) 125 mg
Gemcitabine + Cisplatin
Stomatitis
Gastrointestinal disorders
—
—
COVID-19
Infections and infestations
—
—
Eye pain
Eye disorders
—
—
Dysphagia
Gastrointestinal disorders
—
—
Fatigue
General disorders
—
—
Sepsis
Infections and infestations
—
—
Calciphylaxis
Metabolism and nutrition disorders
—
—
Hypercalcaemia
Metabolism and nutrition disorders
—
—
Hyperphosphataemia
Metabolism and nutrition disorders
—
—
Hypokalaemia
Metabolism and nutrition disorders
—
—
Pain in extremity
Musculoskeletal and connective tissue disorders
—
—
Hypercalcaemia of malignancy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Dizziness
Nervous system disorders
—
—
Erythema nodosum
Skin and subcutaneous tissue disorders
—
—
Other adverse events (150 terms — click to expand)
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 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 locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
NCT03510455 — BGJ398 for the Treatment of Tumor-Induced Osteomalacia
· Phase 2
· terminated
NCT02706691 — BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer
· Phase 2
· terminated
NCT02657486 — BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
· NA
· completed
NCT02257541 — BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)
· Phase 1, PHASE2
· completed
NCT02160041 — BGJ398 for Patients With Tumors With FGFR Genetic Alterations
· Phase 2
· terminated
Other recruiting trials for Advanced Cholangiocarcinoma
Currently open trials in the same condition.
NCT06439485 — Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarc
· Phase 1, PHASE2
· recruiting
NCT05823311 — Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
· Phase 3
· recruiting
NCT05969860 — At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
· Phase 2
· recruiting
NCT05791448 — AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease
· Phase 1
· recruiting
NCT05532059 — Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma
· Phase 2
· recruiting
Other QED Therapeutics, a BridgeBio company trials
Trials by the same sponsor.
NCT07393373 — Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia
· Phase 2
· enrolling by invitation
NCT06164951 — A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia
· Phase 3
· completed
NCT05145010 — Extension Study of Infigratinib in Children With Achondroplasia (ACH)
· Phase 2
· enrolling by invitation
NCT04197986 — Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genet
· Phase 3
· terminated
NCT04265651 — Study of Infigratinib in Children With Achondroplasia
· Phase 2
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by QED Therapeutics, a BridgeBio company
Last refreshed: 8 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03773302.