Colorectal Cancer, Ovarian Cancer Clinical Trial
Official title:
Open-label, Exploratory, Pharmacodynamic (PD) Dose-finding Study of Intravenous RO5323441 in Patients With Metastatic Treatment-refractory Colorectal and Ovarian Cancer
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.
| Status | Completed |
| Enrollment | 7 |
| Est. completion date | September 2010 |
| Est. primary completion date | September 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Belgium, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI | up to 19.5 months | No | |
| Secondary | Feasibility of within-patient dose escalation | from baseline to Day 127 (+/-3) | No | |
| Secondary | Additional DCE-MRI effects (time-course of DCE-MRI effects, test-retest reproducibility) | up to 19.5 months | No | |
| Secondary | Candidate biomarkers associated with PD effect of RO5323441 | up to 19.5 months | No | |
| Secondary | Pharmacokinetics: maximum and trough concentrations of RO5323441 | up to 19.5 months | No | |
| Secondary | Safety and tolerability: Adverse events, vital signs, laboratory parameters | up to 19.5 months | No | |
| Secondary | Efficacy: ORR, duration of response, progression-free survival according to RECIST criteria, CTI/MRI assessments | up to 19.5 months | No |