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A Study of RO5045337 in Patients With Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01164033
First received: July 15, 2010
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This open-label, randomized, cross-over study will evaluate the effect of food on 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 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
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
Bethesda, Maryland, United States, 20817
United States, Texas
Dallas, Texas, United States, 75230
San Antonio, Texas, United States, 78229
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: May 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013