A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer

Roche

Status and phase: Completed; Phase 1

Conditions: Colorectal Cancer, Ovarian Cancer

Treatments: Drug: RO5323441

Study type: Interventional

Funder types: Industry

Identifiers

NCT01148758

BP22909

2009-016014-25

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: RO5323441