Clinical trial NCT00719524: AVE8062 in Combination With Platinum-taxane Doublet in Advanced Solid Tumor
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Neoplasms
Antineoplastic Combined Chemotherapy Protocol
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recommended dose of the combination based on Dose Limiting Toxicities observed
timeFrame: Cycle 1
Secondary outcomes:
measure: Overall safety profile
timeFrame: Treatment period
measure: Pharmacokinetic profile
timeFrame: Cycle 1
measure: Anti-tumor activity of the combination
timeFrame: Every 2 cycles
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Investigational Site Number 250001
city: Milano
country: Italy
facility: Investigational Site Number 380001
city: Bellinzona
country: Switzerland
facility: Investigational Site Number 756001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Bahleda 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.