Completed

NCT Number: NCT01907685

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

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.

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Key information

Conditions

Advanced Neoplastic Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AVE8062

Drug

Pharmaceutical form:Solution for infusion

Route of administration: Intravenous

Other names: Ombrabulin

docetaxel

Drug

Pharmaceutical form: solution for infusion

Route of administration: Intravenous

Other names: XRP6976

Primary outcomes

Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame: 3 weeks (cycle 1)

Secondary outcomes

Number of Participants with Adverse Events

Time frame: Up to disease progression or unacceptable toxicity or study discontinuation criteria (median treatment of 4 cycles)
Plasma concentration of AVE8062 and its metabolite

Time frame: Before AVE8062 infusion, immediately prior to the end of AVE8062 infusion, 5, 10, 25, 45 and 60 minutes then 2, 4, 6, 8-10 and 24 hours post AVE8062 infusion (cycle 1)
Plasma concentration of docetaxel

Time frame: Before docetaxel infusion (corresponding to 24 hours post AVE8062 infusion), 15 minutes before the end of docetaxel infusion, 15 and 45 minutes post docetaxel infusion (cycle 1)
Response evaluation criteria in solid tumors (RECIST) defined objective response

Time frame: Up to disease progression or unacceptable toxicity or study discontinuation criteria (median treatment of 4 cycles)
Biomarkers expression profile of each patient in order to identify preliminary correlation with antitumor activity of the combination treatment in patients with available pre-treatment biopsy

Time frame: End of treatment or until disease progression or unacceptable toxicity or study discontinuation criteria

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

An Open Label, Dose Escalation, Safety and Pharmacokinetic Phase 1 Study With AVE8062 Administered as a 30 Minutes Intravenous Infusion Followed by Docetaxel Administered as an 1 Hour Intravenous Infusion 24 Hours-Apart Every 3 Weeks in Patients With Advanced Solid Tumors

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Jul 25, 2013
Registry last updated: Jul 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.