A Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00811993

Purpose

This study will evaluate the safety and tolerability of R1507 in combination with 12 distinct standard chemotherapy drug regimens 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.

Condition	Intervention	Phase
Neoplasms	Drug: R1507 Drug: gemcitabine Drug: erlotinib [Tarceva] Drug: paclitaxel Drug: bevacizumab [Avastin] Drug: carboplatin Drug: etoposide Drug: mFOLFOX6 Drug: capecitabine [Xeloda] Drug: trastuzumab [Herceptin] Drug: sorafenib Drug: irinotecan Drug: cetuximab Drug: temozolomide Drug: docetaxel Drug: pemetrexel	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	Phase Ib Study To Evaluate The Safety Of Combining IGF-1R Antagonist R1507 With Multiple Standard Chemotherapy Drug Treatments In Patients With Advanced Malignancies

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Adverse events, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Trough levels of R1507 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	January 2009
Estimated Study Completion Date:	November 2010

Arms	Assigned Interventions
1: Experimental	Drug: R1507 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: gemcitabine as prescribed Drug: erlotinib [Tarceva] as prescribed
2: Experimental	Drug: R1507 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: paclitaxel as prescribed Drug: bevacizumab [Avastin] as prescribed
3: Experimental	Drug: R1507 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: carboplatin as prescribed Drug: etoposide as prescribed
4: Experimental	Drug: R1507 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: bevacizumab [Avastin] as prescribed Drug: mFOLFOX6 as prescribed
5: Experimental	Drug: R1507 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: capecitabine [Xeloda] as prescribed Drug: trastuzumab [Herceptin] as prescribed
6: Experimental	Drug: R1507 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: sorafenib as prescribed
7: Experimental	Drug: R1507 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: erlotinib [Tarceva] as prescribed Drug: bevacizumab [Avastin] as prescribed
8: Experimental	Drug: R1507 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: irinotecan as prescribed Drug: cetuximab as prescribed
9: Experimental	Drug: R1507 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: paclitaxel as prescribed Drug: bevacizumab [Avastin] as prescribed Drug: carboplatin as prescribed
10: Experimental	Drug: R1507 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: temozolomide as prescribed
11: Experimental	Drug: R1507 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: bevacizumab [Avastin] as prescribed Drug: docetaxel as prescribed
12: Experimental	Drug: R1507 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: pemetrexel as prescribed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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;
other exclusion criteria are related to specific treatment regimens.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811993

Contacts

Contact: Please reference Study ID Number: NO22068	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

United States, Arizona
	Recruiting
TUCSON, Arizona, United States, 85724
United States, California
	Recruiting
SANTA MONICA, California, United States, 90404
	Recruiting
SAN FRANCISCO, California, United States, 94143
United States, District of Columbia
	Recruiting
WASHINGTON, District of Columbia, United States, 20007-2197
United States, Illinois
	Recruiting
CHICAGO, Illinois, United States, 60637
United States, Minnesota
	Recruiting
ROCHESTER, Minnesota, United States, 55905
United States, North Carolina
	Recruiting
CHAPEL HILL, North Carolina, United States, 27599
United States, Texas
	Recruiting
HOUSTON, Texas, United States, 77030

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NO22068
Study First Received:	December 18, 2008
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00811993 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Immunologic Factors
Irinotecan
Bevacizumab
Etoposide phosphate
Docetaxel
Trastuzumab
Gemcitabine
Etoposide
Alkylating Agents
Erlotinib
Capecitabine

Cetuximab
Carboplatin
Antimitotic Agents
Angiogenesis Inhibitors
Temozolomide
Antiviral Agents
Immunosuppressive Agents
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Alkylating
Sorafenib
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Irinotecan
Physiological Effects of Drugs
Bevacizumab
Therapeutic Uses
Trastuzumab
Growth Inhibitors
Angiogenesis Modulating Agents
Gemcitabine
Alkylating Agents

Capecitabine
Growth Substances
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Angiogenesis Inhibitors
Temozolomide
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators

ClinicalTrials.gov processed this record on September 03, 2009