Trial · NCT02150967
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
NCT02150967, Phase 2, Terminated, QED Therapeutics, a BridgeBio company; results first posted 2022-07-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma. Trials, record NCT02150967. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02150967
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
- NCT number
- NCT02150967
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 143 participants, actual
- Lead sponsor
- QED Therapeutics, a BridgeBio company
- Conditions
- Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
- Interventions
- BGJ398 (infigratinib)
- First posted
- 2014-05-30
- Last updated
- 2023-07-03
- Other registries' IDs
- eudract:2013-005085-19
- Results first posted
- 2022-07-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR) | Analysis was conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | ORR is defined as the percentage (%) of subjects with a best overall response of Complete Response (CR) or Partial Response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions). Results were previously disclosed (22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. |
| Secondary | Overall Response Rate (ORR) as Assessed by the Investigator | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff for the primary analysis was 01 March 2021. | ORR is defined as the percentage (%) of subjects with a best overall response of CR or PR, evaluated by CT or MRI scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) only. These results were previously disclosed (22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. |
| Secondary | Best Overall Response (BOR) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | BOR is defined as the best overall response a subject achieved during the study before any subsequent antineoplastic therapy. The endpoint is summarized for the rate of BOR of CR, PR, progressive disease (PD), and stable disease (SD), evaluated by CT or MRI scans every 28 days. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. PD: at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusion) |
| Secondary | Disease Control Rate (DCR) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | DCR is the percentage (%) of subjects with a BOR of CR, PR, or SD, evaluated by CT or MRI scans every 28 days. Results are based on both BICR and on Investigator assessment. RECIST (v1.1) response criteria were as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). There are no additional efficacy endpoints to assess for Cohort 1, thus efficacy data were not re-analyzed for the final analysis. Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. |
| Secondary | Progression-Free Survival (PFS) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | PFS was calculated as the number of months from the first dose of study drug to the first documented progression or death due to any cause, whichever occurred earlier. Subjects without an assessment of progression or death were censored at the last adequate tumor assessment. For subjects who had an event after ≥2 missed visits, the subject was censored at the last adequate tumor assessment before the missing visit. Disease progression was assessed per RECIST (v1.1) and defined as at least a 20% increase in the sum of diameters of all target lesions from that of the smallest sum on study and an absolute increase in target lesion of at least 5mm. Results are based on both BICR and on Investigator assessment. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. |
| Secondary | Overall Survival (OS) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | OS was defined as the time (months) from the date of start of treatment to the date of death due to any cause. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. |
| Secondary | Duration of Response (DOR) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | DOR is defined as the time (months) from the initial response to the time of the event; defined as the first documented progression or death due to any cause, whichever was earlier. Note that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator. RECIST (v1.1) response criteria was as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. |
| Secondary | Response Onset | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Response onset was defined as the time (months) from the first study treatment administration date to the initial response. Note that results are based on a subgroup of subjects with confirmed responses (CR or PR) as assessed by BICR or by the Investigator. RECIST (v1.1) response criteria was as follows: CR: disappearance of all target lesions. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease from baseline in the sum of diameters of all target lesions. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. |
| Other | Growth Modulation Index (GMI) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | The GMI is defined as the ratio of PFS (months) during treatment with infigratinib relative to the time (months) to progression (TTP) during treatment with last prior line of therapy. Subjects served as their own control. Results are provided for both BICR and Investigator assessment. Note: The primary efficacy outcome measures were prespecified only for Cohort 1 (FGFR fusions) (disclosed 22 June 2022). Due to early termination of the study, no formal efficacy analyses were performed for Cohorts 2 and 3. |
Source ClinicalTrials.gov
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR) | Analysis was conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Percentage (%) of subjects with CR or PR | NUMBER |
| SECONDARY | Overall Response Rate (ORR) as Assessed by the Investigator | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff for the primary analysis was 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Percentage (%) of subjects with CR or PR | NUMBER |
| SECONDARY | Best Overall Response (BOR) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Percentage (%) with CR, PR, or SD | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were confirmed responders (CR or PR) as assessed by BICR (N = 25) or by the Investigator (N = 35). | months | MEDIAN |
| SECONDARY | Response Onset | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were confirmed responders (CR or PR) as assessed by BICR (N = 25) or by the Investigator (N = 35). | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Growth Modulation Index (GMI) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects with both a PFS measure while on infigratinib and available TTP for their last prior line of therapy (N = 103). | Ratio (PFS/TTP) in Months | MEDIAN |
| POST_HOC | Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on ORR | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N = 59). | Percentage (%) of patients with CR or PR | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR) | Cohort 1: FGFR2 Fusions | 23.1 | 95% Confidence Interval 15.6 to 32.2 | Percentage (%) of subjects with CR or PR | |
| Overall Response Rate (ORR) as Assessed by the Investigator | Cohort 1: FGFR2 Fusion/Rearrangements | 32.4 | 95% Confidence Interval 23.7 to 42.1 | Percentage (%) of subjects with CR or PR | |
| Best Overall Response (BOR) | Cohort 1: FGFR2 Fusion/Rearrangements | BOR by BICR / Confirmed CR | 1 | Participants | |
| Best Overall Response (BOR) | Cohort 1: FGFR2 Fusion/Rearrangements | BOR by BICR / Confirmed PR | 24 | Participants | |
| Best Overall Response (BOR) | Cohort 1: FGFR2 Fusion/Rearrangements | BOR by BICR / Stable Disease | 66 | Participants | |
| Best Overall Response (BOR) | Cohort 1: FGFR2 Fusion/Rearrangements | BOR by BICR / Progressive Disease | 11 | Participants | |
| Best Overall Response (BOR) | Cohort 1: FGFR2 Fusion/Rearrangements | BOR by BICR / Not Done | 6 | Participants | |
| Best Overall Response (BOR) | Cohort 1: FGFR2 Fusion/Rearrangements | BOR by Investigator / Confirmed CR | 0 | Participants | |
| Best Overall Response (BOR) | Cohort 1: FGFR2 Fusion/Rearrangements | BOR by Investigator / Confirmed PR | 35 | Participants | |
| Best Overall Response (BOR) | Cohort 1: FGFR2 Fusion/Rearrangements | BOR by Investigator / Stable Disease | 56 | Participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: FGFR2 Fusions | 108 | |
| Overall Study | STARTED | Cohort 2: Other FGFR Alterations | 25 | |
| Overall Study | STARTED | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | 10 | |
| Overall Study | Treatment Ongoing | Cohort 1: FGFR2 Fusions | 0 | |
| Overall Study | Treatment Ongoing | Cohort 2: Other FGFR Alterations | 0 | |
| Overall Study | Treatment Ongoing | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | 0 | |
| Overall Study | Treatment Ended | Cohort 1: FGFR2 Fusions | 108 | |
| Overall Study | Treatment Ended | Cohort 2: Other FGFR Alterations | 25 | |
| Overall Study | Treatment Ended | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | 10 | |
| Overall Study | COMPLETED | Cohort 1: FGFR2 Fusions | 108 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events555
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 | Cohort 1: FGFR2 Fusions | 20 | 108 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Other FGFR Genetic Alterations | 5 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | 0 | 10 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1: FGFR2 Fusions | 9 | 108 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 2: Other FGFR Genetic Alterations | 2 | 25 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | 0 | 10 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 1: FGFR2 Fusions | 7 | 108 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 2: Other FGFR Genetic Alterations | 1 | 25 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | 0 | 10 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1: FGFR2 Fusions | 7 | 108 |
1 to 10 of 555Source ClinicalTrials.gov
See all 555 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: FGFR2 Fusions | 93 | 108 |
| Total, all-cause mortality | Cohort 2: Other FGFR Genetic Alterations | 19 | 25 |
| Total, all-cause mortality | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | 7 | 10 |
| Total, other adverse events | Cohort 1: FGFR2 Fusions | 107 | 108 |
| Total, other adverse events | Cohort 2: Other FGFR Genetic Alterations | 25 | 25 |
| Total, other adverse events | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | 10 | 10 |
| Total, serious adverse events | Cohort 1: FGFR2 Fusions | 35 | 108 |
| Total, serious adverse events | Cohort 2: Other FGFR Genetic Alterations | 11 | 25 |
| Total, serious adverse events | Cohort 3: FGFR2 Fusions and Prior FGFR Inhibitor | 2 | 10 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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