NCT00719524

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_1

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

4.6 years

First QC Date

July 17, 2008

Last Update Submit

March 8, 2013

Conditions

Neoplasms

Keywords

NeoplasmsAntineoplastic Combined Chemotherapy Protocol

Outcome Measures

Primary Outcomes (1)

  • Recommended dose of the combination based on Dose Limiting Toxicities observed

    Cycle 1

Secondary Outcomes (3)

  • Overall safety profile

    Treatment period

  • Pharmacokinetic profile

    Cycle 1

  • Anti-tumor activity of the combination

    Every 2 cycles

Study Arms (1)

1

EXPERIMENTAL
Drug: OMBRABULIN (AVE8062)

Interventions

OMBRABULIN (AVE8062)DRUG

Dose escalation study with combination chemotherapy

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Investigational Site Number 250001

Villejuif, 94805, France

Location

Investigational Site Number 380001

Milan, 20133, Italy

Location

Investigational Site Number 756001

Bellinzona, 6500, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 24898305DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

AC 7700

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

July 1, 2008

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 11, 2013

Record last verified: 2013-03

Locations

FR(1)IT(1)CH(1)