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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00559533
First received: November 15, 2007
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients w ith 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 coh orts of patients will receive dose escalations, and possible changes in dosing s chedule, based on tolerability and pharmacokinetic knowledge gained from prior t reatment cohorts. The anticipated time on study treatment is until disease progr ession or intolerable toxicity.


Condition Intervention Phase
Neoplasms
Drug: RO5045337
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • MTD and associated dose schedule [ Time Frame: Every 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • Dose-limiting toxicities. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Comparison safety and tolerability of daily versus twice daily dosing regimens [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: December 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO5045337
Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559533

Locations
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, 10021
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 98229
France
Bordeaux, France, 33076
Lyon, France, 69373
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00559533     History of Changes
Other Study ID Numbers: NO21280
Study First Received: November 15, 2007
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014