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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.


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms, Malignant

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Trial Information

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.


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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose Limiting Toxicities (DLTs) that will define the MTD

Outcome Time Frame:

3 weeks

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TCD11379

NCT ID:

NCT01193595

Start Date:

September 2010

Completion Date:

October 2013

Related Keywords:

  • Neoplasms, Malignant
  • Neoplasms

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