NCT01148758

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2010

Shorter than P25 for phase_1

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

May 5, 2010

Last Update Submit

November 1, 2016

Conditions

Colorectal Cancer, Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI

    up to 19.5 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: RO5323441

Interventions

RO5323441DRUG

cohorts receiving multiple doses iv

Single Arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Barcelona, Barcelona, 08035, Spain

Location

Unknown Facility

Manchester, M20 4QL, United Kingdom

Location

MeSH Terms

Conditions

Colorectal NeoplasmsOvarian Neoplasms

Interventions

TB-403

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2010

First Posted

June 22, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

GB(1)ES(1)BE(1)