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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT00623870

Public ClinicalTrials.gov record NCT00623870. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 6, 2026, 11:35 AM EST

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Official title

An Open Label Study to Investigate the Maximum Tolerated Dose of RO5045337 in Patients With Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myelogenous Leukemia (CML) in Blast Phase, or Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL / SCLL)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00623870
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
116 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2008 (Type not available)
Primary completion
Nov 2012 (Actual)
Completion
Nov 2012 (Actual)
Last update posted
Nov 2, 2016

2008 – 2012

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Not listed Duarte California 91010 —
Not listed New Brunswick New Jersey 08901 —
Not listed New York New York 10065 —
Not listed Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00623870, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 2, 2016 · Synced Nov 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00623870 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →