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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01148758
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer, Ovarian Cancer Drug: RO5323441 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single Arm Drug: RO5323441
cohorts receiving multiple doses iv

Primary Outcome Measures :
  1. RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI [ Time Frame: up to 19.5 months ]

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

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01148758

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01148758     History of Changes
Other Study ID Numbers: BP22909
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Ovarian Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs