NCT01358903

Brief Summary

This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2011

Typical duration for phase_1

Geographic Reach
3 countries

6 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

First Submitted

Initial submission to the registry

May 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

May 18, 2011

Last Update Submit

November 1, 2016

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (5)

  • Arm A: Safety (Incidence of adverse events related to study drug)

    Until disease progression or unacceptable toxicity (approximately 2 years)

  • Arm A: Maximum tolerated dose of RO5429083

    Until disease progression or unacceptable toxicity (approximately 2 years)

  • Arm A: Tumor Growth Control Rate

    Until disease progression or unacceptable toxicity (approximately 2 years)

  • Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET)

    Until disease progression or unacceptable toxicity (approximately 2 years)

  • Arm A: Pharmacokinetics (serum levels of RO5429083)

    Until disease progression or unacceptable toxicity (approximately 2 years)

Secondary Outcomes (3)

  • Arm A: Recommended dose of RO5429083 for the extension cohort

    Until disease progression or unacceptable toxicity (approximately 2 years)

  • Arm A: Anti-tumor activity of RO5429083

    Until disease progression or unacceptable toxicity (approximately 2 years)

  • Arm B: Target saturation of 89Zr-labelled RO5429083

    Until disease progression or unacceptable toxicity (approximately 2 years)

Study Arms (2)

A

EXPERIMENTAL
Drug: RO5429083

B

EXPERIMENTAL
Drug: RO5429083

Interventions

RO5429083DRUG

Cohorts receiving multiple escalating doses iv

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Metastatic and/or locally advanced malignant CD44-expressing solid tumors
  • Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy
  • Life expectancy of over 12 weeks

You may not qualify if:

  • Concurrent therapy with any other investigational drug
  • Known or suspected CNS metastases including leptomeningeal metastases
  • Active bleeding, bleeding diathesis or history of coagulation disorder
  • Uncontrolled diabetes mellitus
  • Active or uncontrolled infections
  • Patients with HIV infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Seattle, Washington, 98109, United States

Location

Unknown Facility

Paris, 75231, France

Location

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Amsterdam, 1081 HV, Netherlands

Location

Unknown Facility

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 24, 2011

Study Start

June 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

NL(2)FR(2)US(2)