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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00719524

Enrollment

Registered

2008-07-21

Start date

2008-07-31

Completion date

2013-02-28

Last updated

2013-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Neoplasms, Antineoplastic Combined Chemotherapy Protocol

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.

Interventions

DRUGOMBRABULIN (AVE8062)

Dose escalation study with combination chemotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Recommended dose of the combination based on Dose Limiting Toxicities observed	Cycle 1

Secondary

Measure	Time frame
Overall safety profile	Treatment period
Pharmacokinetic profile	Cycle 1
Anti-tumor activity of the combination	Every 2 cycles

Countries

France, Italy, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026