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

Phase 1

Completed

• Conditions: Colorectal Cancer, Ovarian Cancer
• Interventions: Drug: RO5323441

• Registration Number: NCT01148758
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	RO5323441	-

Primary Outcome Measures

Name	Time	Method
RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI	up to 19.5 months

Secondary Outcome Measures

Name	Time	Method
Feasibility of within-patient dose escalation	from baseline to Day 127 (+/-3)
Additional DCE-MRI effects (time-course of DCE-MRI effects, test-retest reproducibility)	up to 19.5 months
Candidate biomarkers associated with PD effect of RO5323441	up to 19.5 months
Pharmacokinetics: maximum and trough concentrations of RO5323441	up to 19.5 months
Safety and tolerability: Adverse events, vital signs, laboratory parameters	up to 19.5 months
Efficacy: ORR, duration of response, progression-free survival according to RECIST criteria, CTI/MRI assessments	up to 19.5 months