Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01193595
First received: August 31, 2010
Last updated: June 12, 2013
Last verified: June 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms, Malignant |
Drug: Ombrabulin (AVE8062) Drug: bevacizumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Incidence of Dose Limiting Toxicities (DLTs) that will define the MTD [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall safety profile of the combination [ Time Frame: up to a maximum follow-up of 1 year ] [ Designated as safety issue: Yes ]
- Pharmacokinetic parameters of ombrabulin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters of bevacizumab [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Pharmacodynamic effect (biomarkers) [ Time Frame: cycle 1 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
Pharmaceutical form:Solution for infusion Route of administration: Intravenous Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193595
Locations
| France | |
| Investigational Site Number 250001 | |
| Villejuif Cedex, France, 94805 | |
| Italy | |
| Investigational Site Number 380001 | |
| Milano, Italy, 20133 | |
| Investigational Site Number 380002 | |
| Milano, Italy, 20132 | |
| United Kingdom | |
| Investigational Site Number 826001 | |
| Sutton, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01193595 History of Changes |
| Other Study ID Numbers: | TCD11379, 2009-017797-20 |
| Study First Received: | August 31, 2010 |
| Last Updated: | June 12, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Neoplasms Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013