Clinical trial · Interventional
AVE8062 in Combination With Platinum-taxane Doublet in Advanced Solid Tumor
An Open-label, Non-randomized, Dose Evaluation, Safety and Pharmacokinetics Phase I Study of AVE8062 in Combination With Platinum Salts (Cisplatin or Carboplatin) and Taxanes (Docetaxel or Paclitaxel), 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)
The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OMBRABULIN (AVE8062) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: OMBRABULIN (AVE8062)
Primary outcomes (1)
- measure
- Recommended dose of the combination based on Dose Limiting Toxicities observed
- timeFrame
- Cycle 1
Secondary outcomes (3)
- measure
- Overall safety profile
- timeFrame
- Treatment period
- measure
- Pharmacokinetic profile
- timeFrame
- Cycle 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced neoplastic disease (i.e. metastatic or locally advanced disease) for which platinum-taxane doublet regimens are approved or constitutes the mainstay of care such as non small cell lung cancer, epithelial ovary cancer, gastric cancer, transitional cell and bladder cancer and head and neck cancer. * Eastern cooperative oncology group (ECOG) performance status of 0 to 1. Exclusion Criteria: * Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy (excluding radiotherapy with palliative intent on non-target lesions), targeted therapy, gene therapy, or patients planning to receive these treatments during the study. * Absence of histologically or cytologically proven cancer at the first diagnosis. * Negative serum/urinary pregnancy test * Washout period of 3 weeks for prior anti-tumor therapy or any investigational treatment The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (1)
- DERIVEDBahleda R, Sessa C, Del Conte G, Gianni L, Capri G, Varga A, Oprea C, Daglish B, Hospitel M, Soria JC. Phase I clinical and pharmacokinetic study of ombrabulin (AVE8062) combined with cisplatin/docetaxel or carboplatin/paclitaxel in patients with advanced solid tumors. Invest New Drugs. 2014 Dec;32(6):1188-96. doi: 10.1007/s10637-014-0119-0. Epub 2014 Jun 6. PMID 24898305