Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid Tumors

NCT ID: NCT01907685

Last Updated: 2013-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2011-02-28

Brief Summary

Primary Objective:

To determine the dose limiting toxicity (DLT), the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of AVE8062 and docetaxel in combination administered sequentially on D1 & D2 respectively every 3 weeks in patients with advanced solid tumors.

Secondary Objectives:

• To define the overall safety profile of the combination.
• To characterize the pharmacokinetic (PK) profile of AVE8062 and docetaxel when administered in combination.
• To evaluate anti-tumor activity of the combination.
• To evaluate potential predictive biomarkers.

The study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. The objective to analyse a set of biological biomarkers in order to identify a potential predictive signature of efficacy for AVE8062 in combination with docetaxel.

Detailed Description

The duration of study for each patient will include 4-week screening phase prior to first inclusion of study drug, 21-day study treatment cycles, end of treatment visit and follow-up phase. Each patient will be treated until disease progression, unacceptable toxicity or other study discontinuation criteria.

Conditions

Advanced Neoplastic Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AVE8062 / Docetaxel

AVE8062 30-minute IV, 11.5 to 42 mg/m2, followed by Docetaxel, 1-hour IV, 75 and 100 mg/m2 in 3-week cycles until disease progression or unacceptable toxicity or study discontinuation criteria

Group Type: EXPERIMENTAL

AVE8062

Intervention Type: DRUG

Pharmaceutical form:Solution for infusion

Route of administration: Intravenous

Docetaxel

Intervention Type: DRUG

Pharmaceutical form: solution for infusion

Route of administration: Intravenous

Interventions

AVE8062

Pharmaceutical form:Solution for infusion

Route of administration: Intravenous

Intervention Type: DRUG

Docetaxel

Pharmaceutical form: solution for infusion

Route of administration: Intravenous

Intervention Type: DRUG

Other Intervention Names

Ombrabulin; XRP6976

Eligibility Criteria

Inclusion Criteria

• Advanced neoplastic disease (i.e metastatic or locally advanced disease) for which docetaxel-based regimen therapy is indicated such as breast, non-small cell lung and prostate cancer.
• ECOG performance status of 0 to 1.

Exclusion Criteria

• Concurrent treatment with any other anticancer therapy.
• Patient with locally advanced or metastatic breast cancer who never received adjuvant chemotherapy.
• Brain metastases and carcinomatous leptomeningitis.
• Prior intensive chemotherapy with autologous stem cell rescue.
• Patients who received a high cumulative dose of anthracycline (i.e doxorubicin > 400mg/m2 or epirubicin >750 mg/m2).
• Impaired cardiovascular function.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

References

Eskens FA, Tresca P, Tosi D, Van Doorn L, Fontaine H, Van der Gaast A, Veyrat-Follet C, Oprea C, Hospitel M, Dieras V. A phase I pharmacokinetic study of the vascular disrupting agent ombrabulin (AVE8062) and docetaxel in advanced solid tumours. Br J Cancer. 2014 Apr 29;110(9):2170-7. doi: 10.1038/bjc.2014.137. Epub 2014 Apr 8.

Reference Type: DERIVED

PMID: 24714750 (View on PubMed)

Other Identifiers

2005-005027-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TCD6295

Identifier Type: -

Identifier Source: org_study_id