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NCT01055067 · ClinicalTrials.gov registry record · Phase 2

ARQ 197 for Participants With Relapsed or Refractory Germ Cell Tumors

A Phase 2 study, sponsored by Daiichi Sankyo.

Terminated
Registry status
Phase 2
Development phase
27
Enrollment target

NCT01055067: Clinical Trial Phase 2 study, sponsored by Daiichi Sankyo.

NCT01055067 is a Phase 2 study that was terminated before completion, run by Daiichi Sankyo. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01055067, a Phase 2 study, was terminated before completion, sponsored by Daiichi Sankyo.

TERMINATED
Registry status
Phase 2
Development phase
27 participants
Enrollment target

Study Summary

This is a multicenter, single-arm study for safety and efficacy.

Primary Outcome

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 Evaluat

Interventions

  • DRUG Tivantinib (ARQ 197)

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2010-02-02
Est. Completion 2011-11-30
Phase Phase 2
Daiichi Sankyo

236 total trials

Why NCT01055067 stopped before completion

NCT01055067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which Tivantinib (ARQ 197) is the first listed.

NCT01055067 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01055067 about?

NCT01055067 is a clinical study titled "ARQ 197 for Participants With Relapsed or Refractory Germ Cell Tumors". This is a multicenter, single-arm study for safety and efficacy.

What is the current status of trial NCT01055067?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2010-02-02. Estimated completion is 2011-11-30.

What interventions are being tested in trial NCT01055067?

The interventions under investigation include: Tivantinib (ARQ 197) (DRUG).

Who is sponsoring clinical trial NCT01055067?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01055067's enrollment target sits among peer trials

27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01055067, the US trial registry maintained by the National Library of Medicine. NCT01055067 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.