A Phase I, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administered Every 3 Weeks in Patients With Advanced Solid Malignancies
Phase 1
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
A Phase I, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administered Every 3 Weeks in Patients With Advanced Solid Malignancies
Inclusion Criteria:
- Histologically confirmed cancer patients without standard of care
- ECOG performance status 0 or 1
- Adequate organ and bone marrow function
Exclusion Criteria:
- Need for a major surgery or radiation therapy during the study
- History of hypersensitivity to docetaxel or polysorbate 80
- Treatment with chemotherapy, hormonal therapy, radiotherapy within 28 days
- Uncontrolled hypertension
- History of brain metastases
- Ascites requiring drainage
- Pregnancy or breastfeeding
- Patients who have previously been treated with aflibercept.
The investigator will evaluate whether there are other reasons why a patient may not
participate.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
Outcome Time Frame:
first 3-week cycle
Safety Issue:
Yes
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
TCD10091
NCT ID:
NCT00545246
Start Date:
October 2007
Completion Date:
July 2012
Related Keywords:
- Neoplasms
- VEGF Trap
- Neoplasms
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