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

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ClinicalTrials.gov Identifier: NCT01358903
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

May 18, 2011
May 24, 2011
November 2, 2016
June 2011
March 2014   (Final data collection date for primary outcome measure)
  • Arm A: Safety (Incidence of adverse events related to study drug) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  • Arm A: Maximum tolerated dose of RO5429083 [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  • Arm A: Tumor Growth Control Rate [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  • Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  • Arm A: Pharmacokinetics (serum levels of RO5429083) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  • Arm A: Pharmacokinetics (serum levels of RO5429083) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  • Arm A: Safety (Incidence of adverse events related to study drug) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  • Arm A: Maximum tolerated dose of RO5429083 [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  • Arm A: Tumor Growth Control Rate [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  • Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
Complete list of historical versions of study NCT01358903 on ClinicalTrials.gov Archive Site
  • Arm A: Recommended dose of RO5429083 for the extension cohort [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  • Arm A: Anti-tumor activity of RO5429083 [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
  • Arm B: Target saturation of 89Zr-labelled RO5429083 [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ]
Same as current
Not Provided
Not Provided
 
A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors
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
This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
  • Drug: RO5429083
    Cohorts receiving multiple escalating doses iv
  • Drug: RO5429083
    Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression
  • Experimental: A
    Intervention: Drug: RO5429083
  • Experimental: B
    Intervention: Drug: RO5429083
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Netherlands,   United States
 
 
NCT01358903
BP25385
2010-021168-13 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP