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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Terminated

CT.gov ID

NCT00811993

Collaborator

(none)

104

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: RG1507 Drug: RO1507 Drug: bevacizumab [Avastin] Drug: capecitabine [Xeloda] Drug: carboplatin Drug: cetuximab Drug: docetaxel Drug: erlotinib [Tarceva] Drug: etoposide Drug: gemcitabine Drug: irinotecan Drug: mFOLFOX6 Drug: paclitaxel Drug: pemetrexel Drug: sorafenib Drug: temozolomide Drug: trastuzumab [Herceptin]	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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: erlotinib [Tarceva] as prescribed Drug: gemcitabine as prescribed
Experimental: 10	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: temozolomide as prescribed
Experimental: 11	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: bevacizumab [Avastin] as prescribed Drug: docetaxel as prescribed
Experimental: 12	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: pemetrexel as prescribed
Experimental: 13	Drug: RO1507 27mg/kg iv, monotherapy
Experimental: 2	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: bevacizumab [Avastin] as prescribed Drug: paclitaxel as prescribed
Experimental: 3	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: carboplatin as prescribed Drug: etoposide as prescribed
Experimental: 4	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: bevacizumab [Avastin] as prescribed Drug: mFOLFOX6 as prescribed
Experimental: 5	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: capecitabine [Xeloda] as prescribed Drug: trastuzumab [Herceptin] as prescribed
Experimental: 6	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: sorafenib as prescribed
Experimental: 7	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: bevacizumab [Avastin] as prescribed Drug: erlotinib [Tarceva] as prescribed
Experimental: 8	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: cetuximab as prescribed Drug: irinotecan as prescribed
Experimental: 9	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: bevacizumab [Avastin] as prescribed Drug: carboplatin as prescribed Drug: paclitaxel as prescribed

Outcome Measures

Primary Outcome Measures

Adverse events, laboratory parameters, vital signs [Throughout study]

Secondary Outcome Measures

Trough levels of R1507 [Throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Tucson	Arizona	United States	85724
2	San Francisco	California	United States	94115
3	Santa Monica	California	United States	90025
4	Washington	District of Columbia	United States	20007
5	Chicago	Illinois	United States	60637
6	Rochester	Minnesota	United States	55905
7	Chapel Hill	North Carolina	United States	27514
8	Houston	Texas	United States	77030