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NCT01225536 · ClinicalTrials.gov registry record · Phase 1

Dose Escalation Study of ARQ 736 in Adult Subjects With Advanced Solid Tumors Harboring BRAF and/or NRAS Mutations

A Phase 1 study, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT01225536: Completed Phase 1 study, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

NCT01225536 is a Phase 1 study that has completed, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01225536, a Phase 1 study, has completed, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

This is an open-label, Phase 1, dose escalation study of oral ARQ 736 administered to subjects with advanced solid tumors harboring the mutation. The study is designed to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of ARQ 736 and to define a recommended Phase 2 dose of ARQ 736.

Interventions

  • DRUG ARQ 736

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2010-10
Est. Completion 2013-03
Phase Phase 1

What the finished NCT01225536 record still lists

NCT01225536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 1 intervention - of which ARQ 736 is the first listed.

NCT01225536 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01225536 about?

NCT01225536 is a clinical study titled "Dose Escalation Study of ARQ 736 in Adult Subjects With Advanced Solid Tumors Harboring BRAF and/or NRAS Mutations". This is an open-label, Phase 1, dose escalation study of oral ARQ 736 administered to subjects with advanced solid tumors harboring the mutation. The study is designed to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of ARQ 736 and to define a recommended Phase 2 dose of AR...

What is the current status of trial NCT01225536?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-10. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01225536?

The interventions under investigation include: ARQ 736 (DRUG).

Who is sponsoring clinical trial NCT01225536?

This trial is sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA), which has 27 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01225536's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01225536, the US trial registry maintained by the National Library of Medicine. NCT01225536 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.