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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Starting dose of \>=3mg/kg iv escalating to a maximum dose of \<=16mg/kg iv, depending on dosing schedule in each combination treatment arm
27mg/kg iv, monotherapy
as prescribed
as prescribed
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as prescribed
as prescribed
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Santa Monica, California, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
Chapel Hill, North Carolina, United States
Unnamed facility
Houston, Texas, United States
Adverse events, laboratory parameters, vital signs
Time frame: Throughout study
Trough levels of R1507
Time frame: Throughout study
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