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NCT01677780 · ClinicalTrials.gov registry record · Phase 1
An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies
A Phase 1 study of Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 5
- Study locations
NCT01677780: Completed Phase 1 study of Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute, sponsored by Hoffmann-La Roche.
NCT01677780 is a Phase 1 study of Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute that has completed, run by Hoffmann-La Roche. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01677780, a Phase 1 study of Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 5
- Study locations
Study Summary
This open-label, extension study is designed to provide continuing treatment with RO5045337 to participants who have completed parent studies NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296). Participants are eligible to participate in this study if they have completed required Phase 1 study assessments for primary objectives of respective parent protocol and are having evidence of clinical benefit (as defined by the parent protocol). Participants will continue the most similar dose and formulation available (which does not exceed the maximum tolerated dose \[MTD\] or the maximum safely administered dose for that formulation during Phase 1) and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from the parent clinical study protocol.
Conditions Studied
Interventions
- DRUG RO5045337
Study Locations (5)
Texas
- M.D Anderson Cancer Center; Oncology - Houston
- Cancer Therapy & Research Ctr; Dept Institute for Drug Development - San Antonio
California
- Sarcoma Oncology Center - Santa Monica
Ontario
- Princess Margaret Hospital, Medical Oncology & Haematology - Toronto
Other
- Institut Claudius Regaud; Departement Oncologie Medicale - Toulouse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-11-28 |
| Est. Completion | 2017-06-26 |
| Phase | Phase 1 |
What the finished NCT01677780 record still lists
NCT01677780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute appearing as the primary indexed condition, and to 1 intervention - of which RO5045337 is the first listed.
NCT01677780 lists 5 locations in 4 states (Texas, California, Ontario).
Frequently Asked Questions
What is clinical trial NCT01677780 about?
NCT01677780 is a clinical study titled "An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies". This open-label, extension study is designed to provide continuing treatment with RO5045337 to participants who have completed parent studies NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296). Participants are eligible to participate ...
What is the current status of trial NCT01677780?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2012-11-28. Estimated completion is 2017-06-26.
What conditions does trial NCT01677780 study?
This clinical trial studies the following conditions: Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute.
What interventions are being tested in trial NCT01677780?
The interventions under investigation include: RO5045337 (DRUG).
Who is sponsoring clinical trial NCT01677780?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01677780 being conducted?
This trial has 5 study locations across California, Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01677780's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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