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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01148758
First received: May 5, 2010
Last updated: November 15, 2011
Last verified: November 2011
History of Changes
  Purpose

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 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:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148758

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

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01148758     History of Changes
Other Study ID Numbers: BP22909, 2009-016014-25
Study First Received: May 5, 2010
Last Updated: November 15, 2011
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Colorectal Neoplasms
Ovarian Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
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

ClinicalTrials.gov processed this record on May 16, 2013