Trial · NCT03230318
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
NCT03230318, Phase 2, Completed, Basilea Pharmaceutica; results first posted 2023-12-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma. Trials, record NCT03230318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03230318
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
- NCT number
- NCT03230318
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 148 participants, actual
- Lead sponsor
- Basilea Pharmaceutica
- Conditions
- Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
- Interventions
- derazantinib
- First posted
- 2017-07-26
- Last updated
- 2023-12-19
- Results first posted
- 2023-12-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Substudy 1: Objective Response Rate (ORR) | From first dose and up to 54 months | ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded independent central review using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1 |
| Primary | Substudy 2: Progression Free Survival at 3 Months (PFS 3) | From first dose and up to 3 months | PFS3 was defined as the proportion of patients who have progression-free survival at 3 months from the first date of receiving study drug as assessed by survival status and blinded independent central review as per RECIST 1.1. |
| Secondary | PFS | From first dose and up to 54 months | PFS was calculated from the first date of receiving study drug until radiographic disease progression by blinded independent central review or death. |
| Secondary | Overall Survival (OS) | From first dose and up to 54 months | OS was calculated from the first date of receiving study drug until death |
| Secondary | Duration of Response (DoR) | From first dose and up to 54 months | DoR was calculated from the first date of documented tumor response to disease progression by blinded independent central review per RECIST version 1.1 DoR was derived only for patients who have the best overall response of CR or PR |
| Secondary | Substudy 2: Objective Response Rate | From first dose and up to 54 months | ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded independent central review using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1 |
| Secondary | Number of Patients With Grade 3-5 Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as all events occurring after drug treatment began and up to 30 days after last study drug administration | Number of patients experiencing TEAE of Grade 3 to 5 according to Common Terminology Criteria for Adverse Events (CTCAE) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Substudy 1: Objective Response Rate (ORR) | From first dose and up to 54 months | Intent-to-treat (ITT) Population: included all patients who received any amount of study drug | Percentage of participants | NUMBER |
| PRIMARY | Substudy 2: Progression Free Survival at 3 Months (PFS 3) | From first dose and up to 3 months | Modified intent-to-treat (mITT) Population: included all patients in the Safety/ITT population, who had at least one post-baseline disease assessment (at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression \[every effort was made to objectively assess radiographic progression\]), or reported death during the treatment period. | Percentage of participants | NUMBER |
| SECONDARY | PFS | From first dose and up to 54 months | mITT Population: included all patients in the Safety/ITT population, who had at least one post-baseline disease assessment (at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression \[every effort was made to objectively assess radiographic progression\]), or reported death during the treatment period. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From first dose and up to 54 months | ITT population: included all patients who received any amount of study drug | Months | MEDIAN |
| SECONDARY | Duration of Response (DoR) | From first dose and up to 54 months | ITT Population: included all patients who received any amount of study drug | Months | MEDIAN |
| SECONDARY | Substudy 2: Objective Response Rate | From first dose and up to 54 months | mITT Population: included all patients in the Safety/ITT population, who had at least one post-baseline disease assessment (at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression \[every effort was made to objectively assess radiographic progression\]), or reported death during the treatment period. | Percentage of participants | NUMBER |
| SECONDARY | Number of Patients With Grade 3-5 Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as all events occurring after drug treatment began and up to 30 days after last study drug administration | Safety / ITT population included all patients who received any amount of study drug | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Substudy 1: Objective Response Rate (ORR) | Substudy 1 | 22.3 | 95% Confidence Interval 14.7 to 31.6 | Percentage of participants | |
| Substudy 2: Progression Free Survival at 3 Months (PFS 3) | Substudy 2 | 62.8 | 95% Confidence Interval 46.7 to 77.0 | Percentage of participants | |
| PFS | Substudy 1 | 8.1 | 95% Confidence Interval 5.5 to 8.3 | Months | |
| PFS | Substudy 2 | 8.3 | 95% Confidence Interval 3.5 to NA | Months | |
| Overall Survival (OS) | Substudy 1 | 17.2 | 95% Confidence Interval 12.5 to 22.4 | Months | |
| Overall Survival (OS) | Substudy 2 | 11.9 | 95% Confidence Interval 8.4 to 15.9 | Months | |
| Duration of Response (DoR) | Substudy 1 | 6.5 | Full Range 4.6 to 9.2 | Months | |
| Duration of Response (DoR) | Substudy 2 | NA | Full Range NA to NA | Months | |
| Substudy 2: Objective Response Rate | Substudy 2 | 9.3 | 95% Confidence Interval 2.6 to 22.1 | Percentage of participants | |
| Number of Patients With Grade 3-5 Treatment-emergent Adverse Events (TEAEs) | Substudy 1 | Number of patients with only unrelated TEAEs of Grade 3-5 | 31 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Substudy 1 | 104 | |
| Overall Study | STARTED | Substudy 2 | 44 | |
| Overall Study | COMPLETED | Substudy 1 | 0 | |
| Overall Study | COMPLETED | Substudy 2 | 0 | |
| Overall Study | NOT COMPLETED | Substudy 1 | 104 | |
| Overall Study | NOT COMPLETED | Substudy 2 | 44 |
Source ClinicalTrials.gov
Adverse events236
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 | Alanine aminotransferase increased | Investigations | Substudy 1 | 36 | 103 | 43 |
| other | Alanine aminotransferase increased | Investigations | Substudy 2 | 13 | 44 | 15 |
| other | Aspartate aminotransferase increased | Investigations | Substudy 1 | 46 | 103 | 52 |
| other | Aspartate aminotransferase increased | Investigations | Substudy 2 | 13 | 44 | 15 |
| other | Blood alkaline phosphatase increased | Investigations | Substudy 1 | 17 | 103 | 18 |
| other | Blood alkaline phosphatase increased | Investigations | Substudy 2 | 9 | 44 | 11 |
| other | Blood creatinine increased | Investigations | Substudy 1 | 17 | 103 | 18 |
| other | Blood creatinine increased | Investigations | Substudy 2 | 7 | 44 | 8 |
| other | Blood phosphorus increased | Investigations | Substudy 1 | 13 | 103 | 20 |
| other | Blood phosphorus increased | Investigations | Substudy 2 | 2 | 44 | 2 |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Substudy 1 | 74 | 103 |
| Total, all-cause mortality | Substudy 2 | 25 | 44 |
| Total, other adverse events | Substudy 1 | 103 | 103 |
| Total, other adverse events | Substudy 2 | 43 | 44 |
| Total, serious adverse events | Substudy 1 | 37 | 103 |
| Total, serious adverse events | Substudy 2 | 16 | 44 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30420614 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Substudy 1 vs Substudy 2: deaths from any cause | Trial comparisons |
| Substudy 1 vs Substudy 2: 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/NCT03230318
GET https://conductscience.org/api/trials/v1/NCT03230318/events?page=2