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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Advanced Neoplastic Disease

Treatments: Drug: Docetaxel; Drug: AVE8062

Study type: Interventional

Funder types: Industry

Identifiers

NCT01907685

TCD6295

2005-005027-34 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

58 participants in 1 patient group

AVE8062 / Docetaxel

Experimental group

Description:

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

Treatment:

Drug: AVE8062

Drug: Docetaxel