A Study of RO5045337 in Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01164033
First received: July 15, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This open-label, randomized, cross-over study will evaluate the effect of food o n the pharmacokinetics of single oral doses of RO5045337 in patients with solid tumors. The anticipated time on study treatment is 3 weeks.


Condition Intervention Phase
Neoplasms
Drug: RO5045337
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized 3-Way Crossover, Study to Examine the Food-Effect on Pharmacokinetics of the Current Formulation and Relative Bioavailability of Two New Formulations for RO5045337 in Patients With Solid Tumors Including Lymphoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Examination of potential food-effect on pharmacokinetics of RO5045337 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Evaluation of relative bioavailability of RO5045337 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of safety and tolerability of RO5045337 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Evaluation of pharmacodynamics and biomarkers [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: August 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: RO5045337
single oral dose
Experimental: B Drug: RO5045337
single oral dose
Experimental: C Drug: RO5045337
single oral dose
Experimental: D Drug: RO5045337
single oral dose

  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
  • Histologically confirmed solid tumor
  • Life expectancy of >/=12 weeks
  • ECOG performance status of 0 or 1
  • Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

  • Patients receiving any other investigational agent or therapy administered with the intention to treat their malignancy within 28 days prior to study start
  • Patients with pre-existing gastro-intestinal disorder
  • Patients with uncontrolled intercurrent illness
  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: NCT01164033

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, Kansas
Kansas City, Kansas, United States, 66160-7330
United States, Maryland
Kensignton, Maryland, United States, 20895
United States, Texas
Dallas, Texas, United States, 75230
San Antonio, Texas, United States, 98229
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: NCT01164033     History of Changes
Other Study ID Numbers: NP25299
Study First Received: July 15, 2010
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 20, 2014