Trial · NCT01055067
ARQ 197 for Participants With Relapsed or Refractory Germ Cell Tumors
NCT01055067, Phase 2, Terminated, Daiichi Sankyo; results first posted 2020-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ARQ 197 for Participants With Relapsed or Refractory Germ Cell Tumors. Trials, record NCT01055067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01055067
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ARQ 197 for Participants With Relapsed or Refractory Germ Cell Tumors
- NCT number
- NCT01055067
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Non-CNS Germ Cell Tumors (Seminomas and Nonseminomas)
- Interventions
- Tivantinib (ARQ 197)
- First posted
- 2010-01-25
- Last updated
- 2021-04-06
- Results first posted
- 2020-09-09
- Limitations and caveats
The study was terminated early for futility according to the stopping rule of the Simon 2-stage design since no participants in Stage 1 had achieved either a complete response or partial response. Enrollment halted and Stage 2 did not occur.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Baseline up to first objective response, up to 1 year 9 months postdose | The best overall response was the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], unconfirmed CR, unconfirmed PR, stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. Objective response was defined as the number of participants with confirmed CR and confirmed PR after 4 cycles of therapy with ARQ 197. According to Response Evaluation Criteria in Solid Tumors v 1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, defined as at least a 20% increase in the sum of diameters of target lesions. |
| Secondary | Progression-Free Survival Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Baseline up to progressive disease or death (whichever occurs first), up to 1 year 9 months postdose | Progression-free survival (PFS) is defined as the time from the date of the start of study treatment to the earlier of the dates of the first documentation of progressive disease (PD) or death due to any cause. According to Response Evaluation Criteria in Solid Tumors v 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. |
| Secondary | Overall Survival Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Baseline up to death (any cause), up to 1 year 9 months postdose | Overall survival (OS) was defined as the time from the date of the start of study treatment to the date of death due to any cause. |
| Secondary | Treatment-Emergent Adverse Events Reported in ≥ 10% of Participants Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Baseline up to 30 days after last dose, up to 1 year 9 months postdose | Treatment-emergent adverse events (TEAEs) were defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. |
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 | Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Baseline up to first objective response, up to 1 year 9 months postdose | Objective response rate was assessed in the Full Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Baseline up to progressive disease or death (whichever occurs first), up to 1 year 9 months postdose | Progression-free survival was assessed in the Full Analysis Set. | weeks | MEDIAN |
| SECONDARY | Overall Survival Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Baseline up to death (any cause), up to 1 year 9 months postdose | Overall survival was assessed in the Full Analysis Set. | months | MEDIAN |
| SECONDARY | Treatment-Emergent Adverse Events Reported in ≥ 10% of Participants Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Baseline up to 30 days after last dose, up to 1 year 9 months postdose | Adverse events were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Stage 1: ARQ 197 360 mg BID | Confirmed CR | 0 | Participants | |
| Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Total | Confirmed CR | 0 | Participants | |
| Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Stage 1: ARQ 197 360 mg BID | Confirmed PR | 0 | Participants | |
| Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Total | Confirmed PR | 0 | Participants | |
| Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Stage 1: ARQ 197 360 mg BID | Stable disease | 3 | Participants | |
| Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Total | Stable disease | 5 | Participants | |
| Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Stage 1: ARQ 197 360 mg BID | Progressive disease | 16 | Participants | |
| Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Total | Progressive disease | 20 | Participants | |
| Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Stage 1: ARQ 197 360 mg BID | Objective response rate | 0 | Participants | |
| Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors | Total | Objective response rate | 0 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total | 27 | |
| Overall Study | COMPLETED | Total | 27 | |
| Overall Study | NOT COMPLETED | Total | 0 |
Source ClinicalTrials.gov
Adverse events54
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 | Stage 1: ARQ 197 360 mg BID | 0 | 21 | |
| other | Anaemia | Blood and lymphatic system disorders | Total | 1 | 27 | |
| other | Neutropenia | Blood and lymphatic system disorders | Stage 1: ARQ 197 360 mg BID | 0 | 21 | |
| other | Neutropenia | Blood and lymphatic system disorders | Total | 1 | 27 | |
| other | Constipation | Gastrointestinal disorders | Stage 1: ARQ 197 360 mg BID | 1 | 21 | |
| other | Constipation | Gastrointestinal disorders | Total | 2 | 27 | |
| other | Dry mouth | Gastrointestinal disorders | Stage 1: ARQ 197 360 mg BID | 1 | 21 | |
| other | Dry mouth | Gastrointestinal disorders | Total | 1 | 27 | |
| other | Nausea | Gastrointestinal disorders | Stage 1: ARQ 197 360 mg BID | 3 | 21 | |
| other | Nausea | Gastrointestinal disorders | Total | 4 | 27 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1: ARQ 197 360 mg BID | 0 | 21 |
| Total, all-cause mortality | Total | 0 | 27 |
| Total, other adverse events | Stage 1: ARQ 197 360 mg BID | 11 | 21 |
| Total, other adverse events | Total | 15 | 27 |
| Total, serious adverse events | Stage 1: ARQ 197 360 mg BID | 6 | 21 |
| Total, serious adverse events | Total | 9 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Stage 1: ARQ 197 360 mg BID vs Total: deaths from any cause | Trial comparisons |
| Stage 1: ARQ 197 360 mg BID vs Total: 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/NCT01055067
GET https://conductscience.org/api/trials/v1/NCT01055067/results?page=2