Neoplasms
Conditions
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.
Interventions
DRUGRG1507
Starting dose of \>=3mg/kg iv escalating to a maximum dose of \<=16mg/kg iv, depending on dosing schedule in each combination treatment arm
DRUGRO1507
27mg/kg iv, monotherapy
DRUGbevacizumab [Avastin]
as prescribed
DRUGcapecitabine [Xeloda]
as prescribed
DRUGcarboplatin
as prescribed
DRUGcetuximab
as prescribed
DRUGdocetaxel
as prescribed
DRUGerlotinib [Tarceva]
as prescribed
DRUGetoposide
as prescribed
DRUGgemcitabine
as prescribed
DRUGirinotecan
as prescribed
DRUGmFOLFOX6
as prescribed
DRUGpaclitaxel
as prescribed
DRUGpemetrexel
as prescribed
DRUGsorafenib
as prescribed
DRUGtemozolomide
as prescribed
as prescribed
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, laboratory parameters, vital signs | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Trough levels of R1507 | Throughout study |
Countries
United States
Outcome results
None listed