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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358903
• Other study ID #: BP25385
• Secondary ID: 2010-021168-13
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2011
• Last updated: November 1, 2016
• Start date: June 2011
• Est. completion date: March 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• RO5429083
Cohorts receiving multiple escalating doses iv
• RO5429083
Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm A: Safety (Incidence of adverse events related to study drug)		Until disease progression or unacceptable toxicity (approximately 2 years)	No
Primary	Arm A: Maximum tolerated dose of RO5429083		Until disease progression or unacceptable toxicity (approximately 2 years)	No
Primary	Arm A: Tumor Growth Control Rate		Until disease progression or unacceptable toxicity (approximately 2 years)	No
Primary	Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET)		Until disease progression or unacceptable toxicity (approximately 2 years)	No
Primary	Arm A: Pharmacokinetics (serum levels of RO5429083)		Until disease progression or unacceptable toxicity (approximately 2 years)	No
Secondary	Arm A: Recommended dose of RO5429083 for the extension cohort		Until disease progression or unacceptable toxicity (approximately 2 years)	No
Secondary	Arm A: Anti-tumor activity of RO5429083		Until disease progression or unacceptable toxicity (approximately 2 years)	No
Secondary	Arm B: Target saturation of 89Zr-labelled RO5429083		Until disease progression or unacceptable toxicity (approximately 2 years)	No