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NCT01605526 · ClinicalTrials.gov registry record · Phase 1

A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma

A Phase 1 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target

NCT01605526: Completed Phase 1 study, sponsored by Hoffmann-La Roche.

NCT01605526 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01605526, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target

Study Summary

This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.

Interventions

  • DRUG doxorubicin
  • DRUG RO5045337

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2012-05
Est. Completion 2013-06
Phase Phase 1
Hoffmann-La Roche

909 total trials

What the finished NCT01605526 record still lists

NCT01605526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 2 interventions - of which doxorubicin is the first listed.

NCT01605526 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01605526 about?

NCT01605526 is a clinical study titled "A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma". This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in comb...

What is the current status of trial NCT01605526?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2012-05. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01605526?

The interventions under investigation include: doxorubicin (DRUG), RO5045337 (DRUG).

Who is sponsoring clinical trial NCT01605526?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01605526's enrollment target sits among peer trials

23 1596th of 2000 higher than 400 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 NCT01605526, the US trial registry maintained by the National Library of Medicine. NCT01605526 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.