A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients
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
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2007
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedOctober 16, 2013
October 1, 2013
4.8 years
October 16, 2007
October 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
first 3-week cycle
Secondary Outcomes (3)
safety: physical examination, laboratory safety tests, adverse events
up to 60 days after last treatment
pharmacokinetic values
every 3-week cycle
objective response rate
every 3-week cycle
Study Arms (1)
aflibercept + docetaxel
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed cancer patients without standard of care
- ECOG performance status 0 or 1
- Adequate organ and bone marrow function
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (2)
Sanofi-Aventis Investigational Site Number 392002
Iruma-gun, Japan
Sanofi-Aventis Investigational Site Number 392001
Sunto-Gun, Japan
Related Publications (1)
Sunakawa Y, Takahashi K, Kawaguchi O, Yamamoto N. Phase I study of aflibercept in combination with docetaxel in Japanese patients with advanced solid malignancies. Invest New Drugs. 2022 Oct;40(5):1032-1041. doi: 10.1007/s10637-022-01267-x. Epub 2022 Jun 30.
PMID: 35771301DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
October 1, 2007
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
October 16, 2013
Record last verified: 2013-10