A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01358903

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

10.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: RO5429083 Drug: RO5429083	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: RO5429083 Cohorts receiving multiple escalating doses iv
Experimental: B	Drug: RO5429083 Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression

Arm

Intervention/Treatment

Experimental: A

Drug: RO5429083

Cohorts receiving multiple escalating doses iv

Experimental: B

Drug: RO5429083

Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Houston	Texas	United States	77030
2	Seattle	Washington	United States	98109
3	Paris		France	75231
4	Toulouse		France	31059
5	Amsterdam		Netherlands	1081 HV
6	Nijmegen		Netherlands	6500 HB

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01358903

Other Study ID Numbers:

BP25385
2010-021168-13

First Posted:

May 24, 2011

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Study Results

No Results Posted as of Nov 2, 2016