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NCT Number: NCT01148758

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

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.

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Key information

Conditions

Colorectal Cancer, Ovarian Cancer Adnexal Diseases Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Rectal Diseases Urogenital Diseases Urogenital Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5323441

Drug

cohorts receiving multiple doses iv

Primary outcomes

  1. RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI

    Time frame: up to 19.5 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Open-label, Exploratory, Pharmacodynamic (PD) Dose-finding Study of Intravenous RO5323441 in Patients With Metastatic Treatment-refractory Colorectal and Ovarian Cancer

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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