Trial · NCT01752920
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
NCT01752920, Phase 1, Phase 2, Completed, Basilea Pharmaceutica; results first posted 2021-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations. Trials, record NCT01752920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01752920
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
- NCT number
- NCT01752920
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 119 participants, actual
- Lead sponsor
- Basilea Pharmaceutica
- Conditions
- Solid Tumor
- Interventions
- Derazantinib low dose range, Derazantinib middle dose range, Derazantinib high dose range, Derazantinib at recommended phase 2 dose (RP2D)
- First posted
- 2012-12-19
- Last updated
- 2023-06-05
- Results first posted
- 2021-10-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Adverse events were collected and reported from the time of receiving first dose of derazantinib to the end of study assessment and follow-up period (30-day post-treatment) | Adverse events were graded for severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. CTCAE is classifying AEs and their associated severity from Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences) to Grade 5 (Death related to AE) |
| Secondary | Proportion of Patients With an Objective Tumor Response Per RECIST 1.1 | Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated. | The number of patients with an objective tumor response, which included those with either a complete response (CR) or a partial response (PR) based on RECIST v1.1 guidelines which defines criteria for the radiological assessment in tumor response. The objective response rate (ORR) was defined as the proportion of patients with a CR or PR. |
| Secondary | Proportion of Patients With Disease Control Per RECIST 1.1 | Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated. | The number of patients with tumor disease control, which included those with either a complete or partial tumor response, or a stable disease (SD) based on RECIST v1.1 guidelines which defines criteria for the radiological assessment in tumor response. The disease control rate (DCR) was defined as the proportion of patients with CR, PR or SD. |
| Secondary | Progression-free Survival (PFS) | Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated. | PFS was calculated as the time from the date of first dose until documented radiographic disease progression or death from any cause, whichever occurred first. Disease progression is measured according to a specified radiologic increase in tumor size. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Adverse events were collected and reported from the time of receiving first dose of derazantinib to the end of study assessment and follow-up period (30-day post-treatment) | The safety population included all subjects who received at least one dose of derazantinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With an Objective Tumor Response Per RECIST 1.1 | Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated. | Evaluable Population: patients who received at least one cycle of study treatment and had at least one postbaseline tumor evaluation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With Disease Control Per RECIST 1.1 | Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) | Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated. | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | TEAE Grade 1 | 3 | Participants | |
| Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group | TEAE Grade 1 | 1 | Participants | |
| Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Derazantinib 400 mg QOD - 425 mg QD - High Dose Group | TEAE Grade 1 | 1 | Participants | |
| Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Derazantinib 300 mg QD - Expanded Cohort Group | TEAE Grade 1 | 11 | Participants | |
| Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | TEAE Grade 2 | 14 | Participants | |
| Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group | TEAE Grade 2 | 5 | Participants | |
| Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Derazantinib 400 mg QOD - 425 mg QD - High Dose Group | TEAE Grade 2 | 3 | Participants | |
| Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Derazantinib 300 mg QD - Expanded Cohort Group | TEAE Grade 2 | 14 | Participants | |
| Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | TEAE Grade 3 | 9 | Participants | |
| Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs) | Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group | TEAE Grade 3 | 6 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | 29 | |
| Overall Study | STARTED | Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group | 13 | |
| Overall Study | STARTED | Derazantinib 400 mg QOD - 425 mg QD - High Dose Group | 19 | |
| Overall Study | STARTED | Derazantinib 300 mg QD - Expanded Cohort Group | 58 | |
| Overall Study | COMPLETED | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | 0 | |
| Overall Study | COMPLETED | Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group | 0 | |
| Overall Study | COMPLETED | Derazantinib 400 mg QOD - 425 mg QD - High Dose Group | 0 | |
| Overall Study | COMPLETED | Derazantinib 300 mg QD - Expanded Cohort Group | 0 | |
| Overall Study | NOT COMPLETED | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | 29 | |
| Overall Study | NOT COMPLETED | Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events840
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 | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | 2 | 29 | 2 |
| other | Alanine aminotransferase increased | Investigations | Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group | 3 | 13 | 3 |
| other | Alanine aminotransferase increased | Investigations | Derazantinib 400 mg QOD - 425 mg QD - High Dose Group | 4 | 19 | 6 |
| other | Alanine aminotransferase increased | Investigations | Derazantinib 300 mg QD - Expanded Cohort Group | 17 | 58 | 31 |
| other | Aspartate aminotransferase increased | Investigations | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | 7 | 29 | 10 |
| other | Aspartate aminotransferase increased | Investigations | Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group | 7 | 13 | 10 |
| other | Aspartate aminotransferase increased | Investigations | Derazantinib 400 mg QOD - 425 mg QD - High Dose Group | 10 | 19 | 14 |
| other | Aspartate aminotransferase increased | Investigations | Derazantinib 300 mg QD - Expanded Cohort Group | 17 | 58 | 30 |
| other | Bilirubin conjugated increased | Investigations | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | 0 | 29 | 0 |
| other | Bilirubin conjugated increased | Investigations | Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group | 0 | 13 | 0 |
1 to 10 of 840Source ClinicalTrials.gov
See all 840 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | 2 | 29 |
| Total, all-cause mortality | Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group | 0 | 13 |
| Total, all-cause mortality | Derazantinib 400 mg QOD - 425 mg QD - High Dose Group | 2 | 19 |
| Total, all-cause mortality | Derazantinib 300 mg QD - Expanded Cohort Group | 5 | 58 |
| Total, other adverse events | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | 28 | 29 |
| Total, other adverse events | Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group | 13 | 13 |
| Total, other adverse events | Derazantinib 400 mg QOD - 425 mg QD - High Dose Group | 19 | 19 |
| Total, other adverse events | Derazantinib 300 mg QD - Expanded Cohort Group | 58 | 58 |
| Total, serious adverse events | Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group | 9 | 29 |
| Total, serious adverse events | Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group | 2 | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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.
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/NCT01752920
GET https://conductscience.org/api/trials/v1/NCT01752920/results?page=2