Trial record 2 of 7 for:    RO5045337

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: April 7, 2014
Last verified: April 2014
  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:


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
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: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014