Back to resultsA Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer
Primary Purpose
Colorectal Cancer, Ovarian Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO5323441
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer, Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients, >/=19 years of age
- metastatic or unresectable colorectal or ovarian cancer refractory to, or unsuitable for standard therapy
- presence of tumor lesions suitable for DCE-MRI evaluation
- WHO performance status 0-1
- adequate bone marrow, liver and renal function
Exclusion Criteria:
- patient unsuitable for MRI scanning (e.g. metal implants, pacemaker, claustrophobia, hypersensitivity to DCE-MRI contrast material)
- brain metastases
- clinically significant ascites
- active bleeding, bleeding diathesis, oral anti-vitamin K medication (other than low dose coumarin) or history of coagulation disorders
- radiation therapy within 3 weeks, or anti-neoplastic therapy <30 days prior to first dose of study drug
- chronic therapy with systemic steroids or another immunosuppressive agent <2 weeks prior to first dose of study drug
- treated with bevacizumab in last regimen of systemic therapy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI
Secondary Outcome Measures
Feasibility of within-patient dose escalation
Additional DCE-MRI effects (time-course of DCE-MRI effects, test-retest reproducibility)
Candidate biomarkers associated with PD effect of RO5323441
Pharmacokinetics: maximum and trough concentrations of RO5323441
Safety and tolerability: Adverse events, vital signs, laboratory parameters
Efficacy: ORR, duration of response, progression-free survival according to RECIST criteria, CTI/MRI assessments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01148758
Brief Title
A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer
Official Title
Open-label, Exploratory, Pharmacodynamic (PD) Dose-finding Study of Intravenous RO5323441 in Patients With Metastatic Treatment-refractory Colorectal and Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer. Cohorts of patients will receive doses of intravenous RO5323441 in the range of 25mg to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) assessments. In the absence of disease progression and unacceptable toxicity, patients may continue to receive their maximum dose of RO5323441 for a core treatment phase of up to a total of 6 months. Treatment with RO5323441 can be extended at the investigator's discretion until disease progression or unacceptable toxicity occurs. Target sample size is <100.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RO5323441
Intervention Description
cohorts receiving multiple doses iv
Primary Outcome Measure Information:
Title
RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI
Time Frame
up to 19.5 months
Secondary Outcome Measure Information:
Title
Feasibility of within-patient dose escalation
Time Frame
from baseline to Day 127 (+/-3)
Title
Additional DCE-MRI effects (time-course of DCE-MRI effects, test-retest reproducibility)
Time Frame
up to 19.5 months
Title
Candidate biomarkers associated with PD effect of RO5323441
Time Frame
up to 19.5 months
Title
Pharmacokinetics: maximum and trough concentrations of RO5323441
Time Frame
up to 19.5 months
Title
Safety and tolerability: Adverse events, vital signs, laboratory parameters
Time Frame
up to 19.5 months
Title
Efficacy: ORR, duration of response, progression-free survival according to RECIST criteria, CTI/MRI assessments
Time Frame
up to 19.5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >/=19 years of age
metastatic or unresectable colorectal or ovarian cancer refractory to, or unsuitable for standard therapy
presence of tumor lesions suitable for DCE-MRI evaluation
WHO performance status 0-1
adequate bone marrow, liver and renal function
Exclusion Criteria:
patient unsuitable for MRI scanning (e.g. metal implants, pacemaker, claustrophobia, hypersensitivity to DCE-MRI contrast material)
brain metastases
clinically significant ascites
active bleeding, bleeding diathesis, oral anti-vitamin K medication (other than low dose coumarin) or history of coagulation disorders
radiation therapy within 3 weeks, or anti-neoplastic therapy <30 days prior to first dose of study drug
chronic therapy with systemic steroids or another immunosuppressive agent <2 weeks prior to first dose of study drug
treated with bevacizumab in last regimen of systemic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Manchester
ZIP/Postal Code
M20 4QL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer
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