Trial · NCT02989857
Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
NCT02989857, Phase 3, Completed, Institut de Recherches Internationales Servier; results first posted 2022-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy). Trials, record NCT02989857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02989857
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
- NCT number
- NCT02989857
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 187 participants, actual
- Lead sponsor
- Institut de Recherches Internationales Servier
- Conditions
- Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma
- Interventions
- AG-120, Placebo
- First posted
- 2016-12-12
- Last updated
- 2024-08-20
- Results first posted
- 2022-04-13
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) as Determined by the Independent Radiology Committee (IRC) | From the date of randomization to the date of first documentation of disease progression or death due to any cause (Up to approximately 2 years) | PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by the IRC using Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1, or date of death due to any cause, whichever occurred first. Disease progression was defined as greater than or equal to (≥)20 percent (%) increase in sum of the diameter of target lesions, taking as reference the smallest sum diameter recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm) or the appearance of 1 or more new lesions. |
| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study drug up to 28 days after last dose for each intervention (Up to approximately 4 Years) | An AE is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related. An AE or suspected adverse reaction is considered serious (an SAE) if it is fatal, life-threatening, causes in-patient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect in a neonate/infant born to a mother or father exposed to study treatment or is an important medical event. Treatment-emergent adverse events are reported. |
| Secondary | Percentage of Participants Who Experienced Laboratory Abnormalities Reported as Grade 3 or Higher Adverse Events | From first dose of the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years) | The laboratory parameters evaluated by the investigator included hematology and chemistry. Laboratory abnormalities reported in this endpoint are Grade 3 or higher adverse events. Grading categories were determined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. |
| Secondary | Percentage of Participants With Clinically Significant Grade 3 or Higher Vital Signs AEs | From first dose of the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years) | Clinically significant vital signs were recorded as adverse events; there were some vital signs reported as Grade 3 or higher adverse events. Grading categories were determined by NCI CTCAE, version 4.03. |
| Secondary | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline | The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classified participants according to their functional impairment, with scores ranging from 0 to 4. ECOG PS: 0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair. A higher score means a worse functional status. |
| Secondary | Percentage of Participants Who Required At Least One Concomitant Medications During the Treatment | From first dose of study drug up to 28 days after last dose (Up to approximately 4 Years) | Concomitant medications were medications that were ongoing or initiated after the first dose of the study drug but before the last dose plus 28 days. Percentage of participants who required at least one concomitant medications during the study along with their prescribed study drug (AG-120 or placebo) were reported. |
| Secondary | Percentage of Participants With Abnormal Electrocardiogram (ECG) Changes Reported as Adverse Events | Pre-dose C1D1, C2D1; Post-dose C1D1, C1D15, C2D1 and Day 1 of C3D1 and all cycles thereafter up to last dose plus 28 days (Up to approximately 4 years) | |
| Secondary | Overall Survival (OS) | From date of randomization until the date of death due to any cause (Up to approximately 2 years) | Overall survival was defined as the time in months from date of randomization to the date of death due to any cause. Participants without documentation of death at the time of the final collection were censored at the date the participant was last known to be alive, or the final collection date, whichever is earlier. |
| Secondary | Objective Response Rate (ORR) as Assessed by the Investigator RECIST Version 1.1 | From the date of randomization up to confirmed CR or PR (Up to approximately 2 years) | ORR as assessed by the investigator was defined as the percentage of participants with a best overall response (BOR) defined as complete response (CR) or partial response (PR) per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis \<10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. |
| Secondary | ORR as Assessed by the IRC Per RECIST v1.1 | From the date of randomization up to confirmed CR or PR (Up to approximately 2 years) | ORR as assessed by the IRC was defined as the percentage of participants with a best overall response (BOR) defined as complete response (CR) or partial response (PR) per RECIST v1.1. CR: disappearance of all target and non-target lesions (TLs) and all pathological lymph nodes (LNs) (target and non target), with short axis \<10mm. PR: ≥30% decrease in sum of diameters (SOD) from Baseline. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) as Determined by the Independent Radiology Committee (IRC) | From the date of randomization to the date of first documentation of disease progression or death due to any cause (Up to approximately 2 years) | ITT set included all participants who were randomized, with the treatment group designated according to the randomization. Number analyzed is the number of participants with data available for analyses at the specified time point. Two participants were excluded from the analysis as they were randomized in the study after the data cutoff date (31 January 2019) for the analysis of PFS. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study drug up to 28 days after last dose for each intervention (Up to approximately 4 Years) | Safety Analysis Set (SAS) included all participants who received at least one dose of study drug (AG-120 or Placebo). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced Laboratory Abnormalities Reported as Grade 3 or Higher Adverse Events | From first dose of the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years) | SAS included all participants who received at least one dose of study drug (AG-120 or Placebo). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinically Significant Grade 3 or Higher Vital Signs AEs | From first dose of the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years) | SAS included all participants who received at least one dose of study drug (AG-120 or Placebo). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline | ITT population included all participants who were randomized, with the treatment group designated according to the randomization. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Required At Least One Concomitant Medications During the Treatment | From first dose of study drug up to 28 days after last dose (Up to approximately 4 Years) | SAS included all participants who received at least one dose of study drug (AG-120 or Placebo). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Abnormal Electrocardiogram (ECG) Changes Reported as Adverse Events | Pre-dose C1D1, C2D1; Post-dose C1D1, C1D15, C2D1 and Day 1 of C3D1 and all cycles thereafter up to last dose plus 28 days (Up to approximately 4 years) | SAS included all participants who received at least one dose of study drug (AG-120 or Placebo). | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From date of randomization until the date of death due to any cause (Up to approximately 2 years) | ITT population included all participants who were randomized, with the treatment group designated according to the randomization. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) as Assessed by the Investigator RECIST Version 1.1 | From the date of randomization up to confirmed CR or PR (Up to approximately 2 years) | ITT population included all participants who were randomized, with the treatment group designated according to the randomization. Number analyzed is the number of participants with data available for analyses at the specified time point. Two participants were excluded from the analysis as they were randomized in the study after the data cutoff date (31 January 2019) for the analysis of tumor response. | percentage of participants | NUMBER |
| SECONDARY | ORR as Assessed by the IRC Per RECIST v1.1 | From the date of randomization up to confirmed CR or PR (Up to approximately 2 years) | ITT population included all participants who were randomized, with the treatment group designated according to the randomization. Number analyzed is the number of participants with data available for analyses at the specified time point. Two participants were excluded from the analysis as they were randomized in the study after the data cutoff date (31 January 2019) for the analysis of tumor response. | percentage of participants | NUMBER |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group348
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) as Determined by the Independent Radiology Committee (IRC) | AG-120 | 2.7 | 95% Confidence Interval 1.6 to 4.2 | months | |
| Progression Free Survival (PFS) as Determined by the Independent Radiology Committee (IRC) | Placebo | 1.4 | 95% Confidence Interval 1.4 to 1.6 | months | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AG-120 | AEs | 97.6 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | AEs | 96.6 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | After Crossover to AG-120 | AEs | 95.3 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AG-120 | SAEs | 35.0 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | SAEs | 23.7 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | After Crossover to AG-120 | SAEs | 27.9 | percentage of participants | |
| Percentage of Participants Who Experienced Laboratory Abnormalities Reported as Grade 3 or Higher Adverse Events | AG-120 | Anaemia | 7.3 | percentage of participants | |
| Percentage of Participants Who Experienced Laboratory Abnormalities Reported as Grade 3 or Higher Adverse Events | Placebo | Anaemia | 0.0 | percentage of participants |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization Phase | STARTED | AG-120 | 126 | |
| Randomization Phase | STARTED | Placebo | 61 | |
| Randomization Phase | STARTED | After Crossover to AG-120 | 0 | |
| Randomization Phase | COMPLETED | AG-120 | 123 | |
| Randomization Phase | COMPLETED | Placebo | 59 | |
| Randomization Phase | COMPLETED | After Crossover to AG-120 | 0 | |
| Randomization Phase | NOT COMPLETED | AG-120 | 3 | |
| Randomization Phase | NOT COMPLETED | Placebo | 2 | |
| Randomization Phase | NOT COMPLETED | After Crossover to AG-120 | 0 | |
| Cross Over Phase | STARTED | AG-120 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events399
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 | Nausea | Gastrointestinal disorders | AG-120 | 52 | 123 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 17 | 59 | |
| other | Nausea | Gastrointestinal disorders | After Cross Over to AG-120 | 12 | 43 | |
| other | Diarrhoea | Gastrointestinal disorders | AG-120 | 43 | 123 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 10 | 59 | |
| other | Diarrhoea | Gastrointestinal disorders | After Cross Over to AG-120 | 12 | 43 | |
| other | Fatigue | General disorders | AG-120 | 38 | 123 | |
| other | Fatigue | General disorders | Placebo | 10 | 59 | |
| other | Fatigue | General disorders | After Cross Over to AG-120 | 10 | 43 | |
| other | Abdominal pain | Gastrointestinal disorders | AG-120 | 30 | 123 |
1 to 10 of 399Source ClinicalTrials.gov
See all 399 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AG-120 | 99 | 126 |
| Total, all-cause mortality | Placebo | 14 | 61 |
| Total, all-cause mortality | After Cross Over to AG-120 | 34 | 43 |
| Total, other adverse events | AG-120 | 118 | 123 |
| Total, other adverse events | Placebo | 56 | 59 |
| Total, other adverse events | After Cross Over to AG-120 | 36 | 43 |
| Total, serious adverse events | AG-120 | 43 | 123 |
| Total, serious adverse events | Placebo | 14 | 59 |
| Total, serious adverse events | After Cross Over to AG-120 | 12 | 43 |
Source ClinicalTrials.gov
Papers4
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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