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A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00559533
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, 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. The anticipated time on study treatment is until disease progression or intolerable toxicity.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: RO5045337 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia
Study Start Date : December 2007
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: 1 Drug: RO5045337
Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)

Primary Outcome Measures :
  1. MTD and associated dose schedule [ Time Frame: Every 28 days ]

Secondary Outcome Measures :
  1. Clinical response [ Time Frame: Event driven ]
  2. Dose-limiting toxicities. [ Time Frame: Throughout study ]
  3. Pharmacokinetic profile [ Time Frame: Throughout study ]
  4. Comparison safety and tolerability of daily versus twice daily dosing regimens [ Time Frame: approximately 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • solid tumor malignancies;
  • failed prior therapies, or no standard 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00559533

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United States, Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, New York
New York, New York, United States, 10065
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 98229
Bordeaux, France, 33076
Lyon, France, 69373
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT00559533    
Other Study ID Numbers: NO21280
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016