Trial information
A Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors
Status: Recruiting
Protocol number: NO22068
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
Brief summary: 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.
Target sample size is
240
.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety study
Condition: Neoplasms
Intervention type: Drug
Intervention name: R1507
Primary outcome: 1
.
Adverse events, laboratory parameters, vital signs
Time frame:
Throughout study
Key secondary outcomes: 1. Trough levels of R1507 Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2009
Trial registration date: 12/18/2008
Date last updated: 8/4/2009
Link to trial result
This trial is being conducted at the following locations:
United States
- Tucson , AZ
- San Francisco, CA
- Santa Monica, CA
- Washington, DC
- Chicago, IL
- Rochester, MN
- Chapel Hill, NC
- Houston, TX
