A Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors

Summary

This study will evaluate the safety and tolerability of R1507 in combination with 12 distinct standard chemotherapy drug regimens and an additional R1507 monotherapy arm in patients with advanced malignant neoplasms.The 12 regimens will be tested in parallel. There are 3 subsets of patients who are eligible for the study: untreated, treated and requiring further treatment, or treated and failed and for whom adding R1507 represents a suitable treatment for their disease. All regimens will first test doses of R1507 which are less than the maximally administered dose, and if tolerated, the dose will be escalated in subsequent patients. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Conditions

• Neoplasms

Interventions

DRUG

RG1507

Starting dose of \>=3mg/kg iv escalating to a maximum dose of \<=16mg/kg iv, depending on dosing schedule in each combination treatment arm

DRUG

RO1507

27mg/kg iv, monotherapy

DRUG

bevacizumab [Avastin]

as prescribed

DRUG

capecitabine [Xeloda]

as prescribed

DRUG

carboplatin

as prescribed

DRUG

cetuximab

as prescribed

DRUG

docetaxel

as prescribed

DRUG

erlotinib [Tarceva]

as prescribed

DRUG

etoposide

as prescribed

DRUG

gemcitabine

as prescribed

DRUG

irinotecan

as prescribed

DRUG

mFOLFOX6

as prescribed

DRUG

paclitaxel

as prescribed

DRUG

pemetrexel

as prescribed

DRUG

sorafenib

as prescribed

DRUG

temozolomide

as prescribed

DRUG

trastuzumab [Herceptin]

as prescribed

Sponsors & Collaborators

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-02-28

Primary Completion

2012-12-31

Completion

2012-12-31

Countries

• United States

Study Locations