NCT00545246CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
Study Overview
Brief Summary
The primary objective of this study is to determine the dose of aflibercept to be further studied in combination with docetaxel in Japanese cancer patients.
The secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
aflibercept + docetaxel
Experimental
Intervention: aflibercept (AVE0005) (Drug)
aflibercept + docetaxel
Experimental
Intervention: docetaxel (Drug)
Outcomes
Primary Outcomes
Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
Time Frame: first 3-week cycle
Secondary Outcomes
- pharmacokinetic values(every 3-week cycle)
- safety: physical examination, laboratory safety tests, adverse events(up to 60 days after last treatment)
- objective response rate(every 3-week cycle)
Investigators
Study Sites (2)
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