Clinical trial NCT01358903: A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Arm A: Safety (Incidence of adverse events related to study drug)
timeFrame: Until disease progression or unacceptable toxicity (approximately 2 years)
measure: Arm A: Maximum tolerated dose of RO5429083
timeFrame: Until disease progression or unacceptable toxicity (approximately 2 years)
measure: Arm A: Tumor Growth Control Rate
timeFrame: Until disease progression or unacceptable toxicity (approximately 2 years)
measure: Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET)
timeFrame: Until disease progression or unacceptable toxicity (approximately 2 years)
measure: Arm A: Pharmacokinetics (serum levels of RO5429083)
timeFrame: Until disease progression or unacceptable toxicity (approximately 2 years)
Secondary outcomes:
measure: Arm A: Recommended dose of RO5429083 for the extension cohort
timeFrame: Until disease progression or unacceptable toxicity (approximately 2 years)
measure: Arm A: Anti-tumor activity of RO5429083
timeFrame: Until disease progression or unacceptable toxicity (approximately 2 years)
measure: Arm B: Target saturation of 89Zr-labelled RO5429083
timeFrame: Until disease progression or unacceptable toxicity (approximately 2 years)
Other outcomes:
Locations:
city: Houston
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Paris
country: France
city: Toulouse
country: France
city: Amsterdam
country: Netherlands
city: Nijmegen
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: