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OpenTrials
Completed

NCT Number: NCT00623870

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 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.

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Key information

Conditions

Hematologic Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, >=18 years of age
  • Acute myeloid leukemia, acute lymphocytic leukemia, chronic myelogenous leukemia in blast phase, refractory chronic lymphocytic leukemia/small cell lymphocytic lymphoma
  • Relapsed or refractory to approved therapies, or no viable alternative therapy available
  • ECOG performance status of 0-2

Exclusion criteria

  • Patients receiving any other agent or therapy to treat their malignancy
  • Pre-existing gastrointestinal disorders which may interfere with absorption of drugs
  • Clinically significant cardiovascular disease
  • Pregnant or lactating women
  • HIV-positive patients receiving combination antiretroviral therapy
  • Amendment J and onward for patients in the food effect evaluation and for all subsequent patients if dosing with a high fat/high calorie meal is found to be optimal: Patients with allergies to any ingredient in the defined liquid supplement and/or inability to tolerate a high fat/high calorie meal twice daily on scheduled RO5045337 dosing days

Treatment and study plan

RO5045337

Drug

Multiple ascending doses

Primary outcomes

  1. Maximum tolerated dose/Dose-limiting toxicities

    Time frame: approximately 4.5 years

  2. Safety: Incidence of adverse events

    Time frame: approximately 4.5 years

  3. Comparison of daily versus twice daily dosing: Incidence of adverse events

    Time frame: approximately 4.5 years

Secondary outcomes

  1. Pharmacokinetics: Blood/Urine concentrations

    Time frame: Pre- and post-dose multiple sampling Days 1+2/Days 1+10 Cycle 1, post-dose sampling Days 11+15 Cycle 1, pre-dose Days 1+2 Cycle 2

  2. Pharmacodynamics: Blood leukemia cells/MIC-1 protein level/CD33+CD34 markers

    Time frame: Pre- and post-dose Days 1+10 Cycle 1, pre-dose Day 2 Cycle 1, Days 1+2 Cycle 2

  3. Clinical response: Clinical/hematologic malignancy assessments

    Time frame: approximately 4.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 26, 2008
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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