Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01193595
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):

August 31, 2010
September 2, 2010
December 3, 2014
September 2010
October 2014   (Final data collection date for primary outcome measure)
Incidence of Dose Limiting Toxicities (DLTs) that will define the MTD [ Time Frame: 3 weeks ]
Same as current
Complete list of historical versions of study NCT01193595 on Archive Site
  • Overall safety profile of the combination [ Time Frame: up to a maximum follow-up of 1 year ]
  • Pharmacokinetic parameters of ombrabulin [ Time Frame: 6 weeks ]
  • Pharmacokinetic parameters of bevacizumab [ Time Frame: 6 weeks ]
  • Preliminary evidence of antitumor activity according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: up to a maximum follow-up of 1 year ]
  • Pharmacodynamic effect (biomarkers) [ Time Frame: cycle 1 ]
Same as current
Not Provided
Not Provided
Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors
An Open-label, Non-randomized, Dose Escalation, Safety and Pharmacokinetic Phase I Study of Ombrabulin (AVE8062) in Combination With Bevacizumab Administered by Intravenous Infusion Every 3 Weeks in Patients With Advanced Solid Tumors.

Primary Objective:

- To determine the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of ombrabulin in combination with best tolerated dose of bevacizumab based on the incidence of related Dose Limiting Toxicities (DLTs).

Secondary Objectives:

  • To assess the overall safety profile of the combination
  • To characterize the pharmacokinetic (PK) profile of both ombrabulin and bevacizumab when given in combination
  • To evaluate preliminary evidence of anti-tumor activity
  • To assess the pharmacodynamic effect using (Dynamic Contrast Enhanced Ultra-Sound) DCE-US, measuring biomarkers
The duration of the study for each patient will include an up to 28-day screening phase, 21-day study treatment cycles, an end of treatment visit with a follow-up period. Each patient will participate in only one dose group and will receive AVE8062 with bevacizumab every 3 weeks until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision.
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms, Malignant
  • Drug: Ombrabulin (AVE8062)

    Pharmaceutical form:Solution for infusion

    Route of administration: Intravenous

  • Drug: bevacizumab

    Pharmaceutical form:Solution for infusion

    Route of administration: Intravenous

Experimental: AVE8062/ bevacizumab
The combination of ombrabulin and bevacizumab will be administered every 3 weeks according to the following schedule: One day 1, ombrabulin will be administered as a 30 minutes intravenous (i.v) infusion. Bevacizumab will be administered as a 30-90 minutes i.v. infusion 24 hours after the end of ombrabulin infusion on day 2.
  • Drug: Ombrabulin (AVE8062)
  • Drug: bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Histologically or cytologically proven solid malignant tumor at the first diagnosis with the exception of squamous non small cell lung cancer (NSCLC).
  • Advanced neoplastic disease (i.e. metastatic or locally unresectable advanced disease)
  • Presence of one measurable lesion at baseline in the MTD expanded cohort

Exclusion criteria:

  • ECOG (Eastern cooperativeOncology Group) performance status > 1
  • Concurrent treatment with any other anticancer therapy
  • Pericardial effusion requiring intervention (drainage)
  • History of brain metastasis, spinal cord compression or carcinomatous meningitis or new evidence of brain metastasis on screening Computed tomography (CT) or Magnetic resonance imaging (MRI) scan
  • Diagnosis of squamous Non Squamous Cell Lung Cancer (NSCLC) or with mixed cell type with predominant squamocellular histology
  • Hormone sensitive prostate cancer
  • Abdominal Radiotherapy
  • Major surgery within the last month of study enrollment or surgical wound not fully healed before study enrollment
  • High cumulative doses of anthracycline
  • Inadequate organ function
  • Inadequate hematology function or poor bone marrow reserve
  • Any of the following within 6 months prior to study enrollment: peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease and diverticulitis
  • Any history or underlying cardiac condition that may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   United Kingdom
2009-017797-20 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP