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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.


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose of the combination based on Dose Limiting Toxicities observed

Outcome Time Frame:

Cycle 1

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Italy: Ethics Committee

Study ID:

TCD10620

NCT ID:

NCT00719524

Start Date:

July 2008

Completion Date:

February 2013

Related Keywords:

  • Neoplasms
  • Neoplasms
  • Antineoplastic Combined Chemotherapy Protocol
  • Neoplasms

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