A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients.

The secondary objectives of this study are to assess the safety profile of AVE0005, to determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor effects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients

NCT00545246

Neoplasms

COMPLETED PHASE1

Study of AVE0005 (VEGF Trap) in Locally Advanced or Metastatic Platinum- and Erlotinib- Resistant Non-small-cell-lung Adenocarcinoma

NCT00284141

Pulmonary Diseases Neoplasms, Lung

COMPLETED PHASE2

A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors

NCT01148615

Neoplasm Malignant

COMPLETED PHASE1

Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors

NCT03634982

Solid Tumors

UNKNOWN PHASE1

BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours

NCT01214616

Neoplasms

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aflibercept (AVE0005)

intravenous infusion

Intervention Type DRUG

S-1

oral administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically confirmed cancer patients without standard of care
* ECOG performance status 0, 1, or 2
* Adequate organ and bone marrow function

Exclusion Criteria

* Need for a major surgery or radiation therapy during the study
* History of hypersensitivity to S-1
* Known dihydropyrimidine dehydrogenase deficiency
* Uncontrolled hypertension
* History of brain metastases
* Ascites requiring drainage
* Pregnancy or breastfeeding
* Patients who have previously been treated with AVE0005

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No