Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 5, 2010
Last updated: November 3, 2014
Last verified: November 2014

This exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of RO5323441 in patients with metastatic treatment-refracto ry colorectal or ovarian cancer. Cohorts of patients will receive doses of intra venous 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) assessment s. 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 in vestigator's discretion until disease progression or unacceptable toxicity occur s. Target sample size is <100.

Condition Intervention Phase
Colorectal Cancer, Ovarian Cancer
Drug: RO5323441
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Exploratory, Pharmacodynamic (PD) Dose-finding Study of Intravenous RO5323441 in Patients With Metastatic Treatment-refractory Colorectal and Ovarian Cancer

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI [ Time Frame: up to 19.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility of within-patient dose escalation [ Time Frame: from baseline to Day 127 (+/-3) ] [ Designated as safety issue: No ]
  • Additional DCE-MRI effects (time-course of DCE-MRI effects, test-retest reproducibility) [ Time Frame: up to 19.5 months ] [ Designated as safety issue: No ]
  • Candidate biomarkers associated with PD effect of RO5323441 [ Time Frame: up to 19.5 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: maximum and trough concentrations of RO5323441 [ Time Frame: up to 19.5 months ] [ Designated as safety issue: No ]
  • Safety and tolerability: Adverse events, vital signs, laboratory parameters [ Time Frame: up to 19.5 months ] [ Designated as safety issue: No ]
  • Efficacy: ORR, duration of response, progression-free survival according to RECIST criteria, CTI/MRI assessments [ Time Frame: up to 19.5 months ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: May 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: RO5323441
cohorts receiving multiple doses iv


Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01148758

Leuven, Belgium, 3000
Barcelona, Spain, 08035
United Kingdom
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01148758     History of Changes
Other Study ID Numbers: BP22909, 2009-016014-25
Study First Received: May 5, 2010
Last Updated: November 3, 2014
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Colorectal Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Ovarian Diseases
Rectal Diseases
Urogenital Neoplasms processed this record on November 25, 2014