Trial · NCT03773302
Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
NCT03773302, Phase 3, Terminated, QED Therapeutics, a BridgeBio company; results first posted 2024-05-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations. Trials, record NCT03773302. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03773302
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
- NCT number
- NCT03773302
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 48 participants, actual
- Lead sponsor
- QED Therapeutics, a BridgeBio company
- Conditions
- Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
- Interventions
- BGJ398, Gemcitabine, Cisplatin
- First posted
- 2018-12-12
- Last updated
- 2024-05-08
- Other registries' IDs
- eudract:2018-004004-19
- Results first posted
- 2024-05-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (Central Imaging Assessment) | 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. |
| Secondary | Overall Survival (OS) in Participants Treated With Infigratinib Versus Gemcitabine With Cisplatin | 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 |
| Secondary | Investigator Assessed Progression Free Survival in Participants Treated With Infigratinib Compared to Gemcitabine and Cisplatin | 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. |
| Secondary | Overall Response Rate (ORR) Determined by Blinded Independent Central (BICR) and Investigator Assessment | 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 |
| Secondary | Best Overall Response (BOR) Determined by Blinded Independent Central Assessment and the Investigator. | 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. |
| Secondary | Duration of Response (DOR) Determined by Blinded Independent Central Assessment and the Investigator. | 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. |
| Secondary | Disease Control Rate (DCR=PR+CR+SD) Determined by Blinded Independent Central Assessment and the Investigator. | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) | 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 |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | 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 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (Central Imaging Assessment) | 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. | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS) in Participants Treated With Infigratinib Versus Gemcitabine With Cisplatin | 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. | Months | MEDIAN | |
| SECONDARY | Investigator Assessed Progression Free Survival in Participants Treated With Infigratinib Compared to Gemcitabine and Cisplatin | 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. | Months | MEDIAN | |
| SECONDARY | Overall Response Rate (ORR) Determined by Blinded Independent Central (BICR) and Investigator Assessment | 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). | Intent-to-treat (ITT) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Overall Response (BOR) Determined by Blinded Independent Central Assessment and the Investigator. | 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). | ITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) Determined by Blinded Independent Central Assessment and the Investigator. | 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). | ITT. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR=PR+CR+SD) Determined by Blinded Independent Central Assessment and the Investigator. | 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). | ITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events (AEs) | 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 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) | 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 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (Central Imaging Assessment) | Infigratinib (BGJ398) 125 mg | 7.39 | Full Range 0.03 to 12.85 | Months | |
| Progression-free Survival (Central Imaging Assessment) | Gemcitabine + Cisplatin | 8.02 | Full Range 0.03 to 12.88 | Months | |
| Overall Survival (OS) in Participants Treated With Infigratinib Versus Gemcitabine With Cisplatin | Infigratinib (BGJ398) 125 mg | NA | 95% Confidence Interval 14.36 to NA | Months | |
| Overall Survival (OS) in Participants Treated With Infigratinib Versus Gemcitabine With Cisplatin | Gemcitabine + Cisplatin | NA | 95% Confidence Interval 8.02 to NA | Months | |
| Investigator Assessed Progression Free Survival in Participants Treated With Infigratinib Compared to Gemcitabine and Cisplatin | Infigratinib (BGJ398) 125 mg | 7.39 | Full Range 0.03 to 20.24 | Months | |
| Investigator Assessed Progression Free Survival in Participants Treated With Infigratinib Compared to Gemcitabine and Cisplatin | Gemcitabine + Cisplatin | 5.19 | Full Range 0.03 to 12.88 | Months | |
| Overall Response Rate (ORR) Determined by Blinded Independent Central (BICR) and Investigator Assessment | ORR By Central Assessment | 11 | Participants | ||
| Overall Response Rate (ORR) Determined by Blinded Independent Central (BICR) and Investigator Assessment | ORR By Investigator Assessment | 9 | Participants | ||
| Overall Response Rate (ORR) Determined by Blinded Independent Central (BICR) and Investigator Assessment | ORR by Central Assessment | 3 | Participants | ||
| Overall Response Rate (ORR) Determined by Blinded Independent Central (BICR) and Investigator Assessment | ORR by Investigator Assessment | 2 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Infigratinib (BGJ398) 125 mg | 29 | |
| Overall Study | STARTED | Gemcitabine + Cisplatin | 19 | |
| Overall Study | COMPLETED | Infigratinib (BGJ398) 125 mg | 29 | |
| Overall Study | COMPLETED | Gemcitabine + Cisplatin | 17 | |
| Overall Study | NOT COMPLETED | Infigratinib (BGJ398) 125 mg | 0 | |
| Overall Study | NOT COMPLETED | Gemcitabine + Cisplatin | 2 |
Source ClinicalTrials.gov
Adverse events328
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Infigratinib (BGJ398) 125 mg | 5 | 29 | |
| other | Anaemia | Blood and lymphatic system disorders | Gemcitabine + Cisplatin | 7 | 17 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Infigratinib (BGJ398) 125 mg | 2 | 29 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Gemcitabine + Cisplatin | 3 | 17 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Infigratinib (BGJ398) 125 mg | 0 | 29 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Gemcitabine + Cisplatin | 2 | 17 | |
| other | Neutropenia | Blood and lymphatic system disorders | Infigratinib (BGJ398) 125 mg | 0 | 29 | |
| other | Neutropenia | Blood and lymphatic system disorders | Gemcitabine + Cisplatin | 5 | 17 | |
| other | Tinnitus | Ear and labyrinth disorders | Infigratinib (BGJ398) 125 mg | 1 | 29 | |
| other | Tinnitus | Ear and labyrinth disorders | Gemcitabine + Cisplatin | 2 | 17 |
1 to 10 of 328Source ClinicalTrials.gov
See all 328 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Infigratinib (BGJ398) 125 mg | 0 | 29 |
| Total, all-cause mortality | Gemcitabine + Cisplatin | 0 | 17 |
| Total, other adverse events | Infigratinib (BGJ398) 125 mg | 29 | 29 |
| Total, other adverse events | Gemcitabine + Cisplatin | 17 | 17 |
| Total, serious adverse events | Infigratinib (BGJ398) 125 mg | 10 | 29 |
| Total, serious adverse events | Gemcitabine + Cisplatin | 0 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32580579 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Infigratinib (BGJ398) 125 mg vs Gemcitabine + Cisplatin: Number of Participants With Serious Adverse Events (SAEs) | Trial comparisons |
| Infigratinib (BGJ398) 125 mg vs Gemcitabine + Cisplatin: Number of Participants With Adverse Events (AEs) | Trial comparisons |
| Infigratinib (BGJ398) 125 mg vs Gemcitabine + Cisplatin: deaths from any cause | Trial comparisons |
| Infigratinib (BGJ398) 125 mg vs Gemcitabine + Cisplatin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03773302
GET https://conductscience.org/api/trials/v1/NCT03773302/results?page=2