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COMPLETED Phase 1

A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.

NCT00623870 · View on ClinicalTrials.gov ↗

Study Summary

This study will determine the maximum tolerated dose of RO5045337 and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with hematologic neoplasms. A first cohort of patients will receive the starting dose of 20mg/m2/day orally, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. Different formulations of RO5045337 will be tested and the food effect evaluated. The anticipated time on study treatment is until disease progression or intolerable toxicity.

Conditions Studied

Interventions

  • DRUG RO5045337

Study Locations (11)

Other

  • — Glasgow
  • — Leeds
  • — Oxford

California

  • — Duarte

New Jersey

  • — New Brunswick

New York

  • — New York

Texas

  • — Houston

Ontario

  • — Toronto

Quebec

  • — Montreal

Emilia-Romagna

  • — Bologna

Trial Details

FieldValue
Enrollment Target 116 participants
Start Date 2008-05
Est. Completion 2012-11
Phase Phase 1

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00623870

The ClinicalTrials.gov registry entry for NCT00623870 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hematologic Neoplasms appearing as the primary indexed condition, and to 1 intervention — of which RO5045337 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00623870 reports 11 study locations spanning 9 distinct geographic areas — top geographies include Other, California, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00623870 about?

NCT00623870 is a clinical study titled "A Study of RO5045337 [RG7112] in Patients With Hematologic Neoplasms.". This study will determine the maximum tolerated dose of RO5045337 and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with hematologic neoplasms. A first cohort of patients will receive the starting dose of 20mg/m2/day orally, once daily for 10 d...

What is the current status of trial NCT00623870?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2008-05. Estimated completion is 2012-11.

What conditions does trial NCT00623870 study?

This clinical trial studies the following conditions: Hematologic Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00623870?

The interventions under investigation include: RO5045337 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00623870?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00623870 being conducted?

This trial has 11 study locations across California, New Jersey, New York, Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial