A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01358903
First received: May 18, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally adva nced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will r eceive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.


Condition Intervention Phase
Neoplasms
Drug: RO5429083
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Arm A: Safety (Incidence of adverse events related to study drug) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Arm A: Maximum tolerated dose of RO5429083 [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Arm A: Tumor Growth Control Rate [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Arm A: Pharmacokinetics (serum levels of RO5429083) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arm A: Recommended dose of RO5429083 for the extension cohort [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Arm A: Anti-tumor activity of RO5429083 [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
  • Arm B: Target saturation of 89Zr-labelled RO5429083 [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: June 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: RO5429083
Cohorts receiving multiple escalating doses iv
Experimental: B Drug: RO5429083
Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression

  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
  • Metastatic and/or locally advanced malignant CD44-expressing solid tumors
  • Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy
  • Life expectancy of over 12 weeks

Exclusion Criteria:

  • Concurrent therapy with any other investigational drug
  • Known or suspected CNS metastases including leptomeningeal metastases
  • Active bleeding, bleeding diathesis or history of coagulation disorder
  • Uncontrolled diabetes mellitus
  • Active or uncontrolled infections
  • Patients with HIV infections
  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: NCT01358903

Locations
United States, Texas
Houston, Texas, United States, 77030
United States, Washington
Seattle, Washington, United States, 98109
France
Paris, France, 75231
Toulouse, France, 31059
Netherlands
Amsterdam, Netherlands, 1081 HV
Nijmegen, Netherlands, 6500 HB
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: NCT01358903     History of Changes
Other Study ID Numbers: BP25385, 2010-021168-13
Study First Received: May 18, 2011
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014