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

NCT ID: NCT00811993

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

erlotinib [Tarceva]

Intervention Type DRUG

as prescribed

gemcitabine

Intervention Type DRUG

as prescribed

10

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

temozolomide

Intervention Type DRUG

as prescribed

11

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

bevacizumab [Avastin]

Intervention Type DRUG

as prescribed

docetaxel

Intervention Type DRUG

as prescribed

12

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

pemetrexel

Intervention Type DRUG

as prescribed

13

Group Type EXPERIMENTAL

RO1507

Intervention Type DRUG

27mg/kg iv, monotherapy

2

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

bevacizumab [Avastin]

Intervention Type DRUG

as prescribed

paclitaxel

Intervention Type DRUG

as prescribed

3

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

as prescribed

etoposide

Intervention Type DRUG

as prescribed

4

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

bevacizumab [Avastin]

Intervention Type DRUG

as prescribed

mFOLFOX6

Intervention Type DRUG

as prescribed

5

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

capecitabine [Xeloda]

Intervention Type DRUG

as prescribed

trastuzumab [Herceptin]

Intervention Type DRUG

as prescribed

6

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

sorafenib

Intervention Type DRUG

as prescribed

7

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

bevacizumab [Avastin]

Intervention Type DRUG

as prescribed

erlotinib [Tarceva]

Intervention Type DRUG

as prescribed

8

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

cetuximab

Intervention Type DRUG

as prescribed

irinotecan

Intervention Type DRUG

as prescribed

9

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

bevacizumab [Avastin]

Intervention Type DRUG

as prescribed

carboplatin

Intervention Type DRUG

as prescribed

paclitaxel

Intervention Type DRUG

as prescribed

Interventions

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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

Intervention Type DRUG

RO1507

27mg/kg iv, monotherapy

Intervention Type DRUG

bevacizumab [Avastin]

as prescribed

Intervention Type DRUG

capecitabine [Xeloda]

as prescribed

Intervention Type DRUG

carboplatin

as prescribed

Intervention Type DRUG

cetuximab

as prescribed

Intervention Type DRUG

docetaxel

as prescribed

Intervention Type DRUG

erlotinib [Tarceva]

as prescribed

Intervention Type DRUG

etoposide

as prescribed

Intervention Type DRUG

gemcitabine

as prescribed

Intervention Type DRUG

irinotecan

as prescribed

Intervention Type DRUG

mFOLFOX6

as prescribed

Intervention Type DRUG

paclitaxel

as prescribed

Intervention Type DRUG

pemetrexel

as prescribed

Intervention Type DRUG

sorafenib

as prescribed

Intervention Type DRUG

temozolomide

as prescribed

Intervention Type DRUG

trastuzumab [Herceptin]

as prescribed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* malignant neoplasms;
* failed prior standard curative therapy;
* ECOG performance Status of 0 or 1;
* adequate bone marrow, hepatic and renal function;
* life expectancy greater than 8 weeks.

Exclusion Criteria

* chemotherapy within 2 weeks of start of therapy;
* prior irradiation within 4 weeks prior to start of therapy;
* prior treatment with agents targeting IGF-IR inhibition, or other investigational agents;
* major surgery or significant traumatic injury within 2 weeks prior to study start;
* patients receiving concurrent antibody or immunotherapy;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Tucson, Arizona, United States

Site Status

San Francisco, California, United States

Site Status

Santa Monica, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Chicago, Illinois, United States

Site Status

Rochester, Minnesota, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NO22068

Identifier Type: -

Identifier Source: org_study_id