A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors
This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01358903
First received: May 18, 2011
Last updated: June 11, 2013
Last verified: June 2013
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Purpose
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.
| 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: Pharmacokinetics (serum levels of RO5429083) [ Time Frame: Until disease progression or unacceptable toxicity (approximately 2 years) ] [ Designated as safety issue: No ]
- 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 ]
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 ]
| Estimated Enrollment: | 73 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358903
Contacts
| Contact: Reference Study ID Number: BP25385 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
Locations
| United States, Texas | |
| Recruiting | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Recruiting | |
| Seattle, Washington, United States, 98109 | |
| France | |
| Recruiting | |
| Paris, France, 75231 | |
| Recruiting | |
| Toulouse, France, 31059 | |
| Netherlands | |
| Recruiting | |
| Amsterdam, Netherlands, 1081 HV | |
| Active, not recruiting | |
| 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: | June 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013