Clinical trial · Interventional
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Neoplastic Disease | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AVE8062 | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AVE8062 / Docetaxel
- 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
- interventionNames
- Drug: AVE8062
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Number of Participants With Dose Limiting Toxicities (DLTs)
- timeFrame
- 3 weeks (cycle 1)
Secondary outcomes (5)
- measure
- Number of Participants with Adverse Events
- timeFrame
- Up to disease progression or unacceptable toxicity or study discontinuation criteria (median treatment of 4 cycles)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDEskens 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. PMID 24714750