Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks

Pharmaceutical form:solution

Route of administration: intravenous

Ombrabulin (AVE8062)

Clinical Sciences & Operations

The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors.

Secondary Objectives:

* To assess the overall safety profiles of the combination therapy
* To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, paclitaxel, and carboplatin when used in combination
* To document the objective tumor response

The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period.

A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors

An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Paclitaxel and Carboplatin Every 3 Weeks in Patients With Advanced Solid Tumors

Sanofi

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

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.

Pharmaceutical form:Solution for infusion

Route of administration: Intravenous

bevacizumab

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.

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.

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Carcinoma

Disease Attributes

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Placebo

Primary Objective:

- To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin.

Secondary Objectives:

* To compare the overall survival (OS) between the 2 treatment arms
* To compare the objective response rate (RR) between the 2 treatment arms

Treatment will continue until disease progression or unacceptable toxicity or consent withdrawal. A minimum of 6 cycles of the combined therapies should be administered, unless progression occurs before or safety reasons cause the discontinuation of one or two drugs of the combination therapies. In case of no progression, it will be investigator's decision to continue or not the study treatment after 6 cycles according to his clinical practice.

Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel

A Phase 2, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel

Cisplatin

Single, 30 minute, intravenous infusion of 25 mg/m² of \[14C\]-AVE8062 containing 1.85 MBq (50µCi) at the first cycle, followed by subsequent administrations with non-radiolabelled AVE8062 in combination with cisplatin every 3 weeks, according to the investigator's judgment.

Pharmaceutical form:concentrate solution

Route of administration: intravenous infusion

Primary Objectives:

* To determine the excretion balance and systemic exposure of radioactivity after intravenous infusion of \[14C\]-AVE8062 to humans
* To determine the pharmacokinetics of AVE8062 and RPR258063 and their contribution to overall exposure
* To collect samples to determine the metabolic pathways of AVE8062 and identify the chemical structures of the main metabolites

Secondary Objective:

* To assess the safety profile of the drug

The duration of the study for each patient will include approximately 4 weeks of a screening phase prior to first infusion of study drug, 21-day study treatment cycles and end of treatment visit. The patient can continue treatment until disease progression, unacceptable toxicity, or the patient's refusal of further treatment.

A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor

A Phase I, Open Label Study Investigating the Disposition of 25 mg/m² [14C]-AVE8062 (1.85 MBq, 50 µCi) Administered at Cycle 1 as a 30-minute Intravenous Infusion to Patients With Advanced Solid Tumors

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Ifosfamide

Isophosphamide mustard

Combretastatin

I.V. infusion followed by administration of cisplatin

OMBRABULIN (AVE8062)

The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms

The secondary objectives of the study are :

* To compare the overall survival in the 2 treatment arms
* To compare the objective response rate in the 2 treatment arms
* To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
* To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.

A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies

A Multinational, Randomized, Double-blind Placebo Controlled Study of AVE8062 (25 mg/m2) Administered Every 3 Weeks in Patients With Advanced-stage Soft Tissue Sarcoma, Treated With Cisplatin (75 mg) After Failure of Anthracycline and Ifosfamide Chemotherapies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors	NCT01293630	Advanced Solid ...	Ombrabulin (AVE... Paclitaxel Carboplatin	20 Years - 75 Years	Sanofi
Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors	NCT01193595	Neoplasms, Mali...	Ombrabulin (AVE... bevacizumab	18 Years -	Sanofi
Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel	NCT01332656	Ovarian Cancer ...	Ombrabulin (AVE... Placebo Paclitaxel Carboplatin	18 Years -	Sanofi
Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors	NCT01193595	Neoplasms, Mali...	Ombrabulin (AVE... bevacizumab	18 Years -	Sanofi
A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors	NCT01293630	Advanced Solid ...	Ombrabulin (AVE... Paclitaxel Carboplatin	20 Years - 75 Years	Sanofi
A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor	NCT01063946	Neoplasms, Mali...	Ombrabulin (AVE...	18 Years -	Sanofi
A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies	NCT00699517	Sarcoma	OMBRABULIN (AVE... Placebo	18 Years -	Sanofi
A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies	NCT00699517	Sarcoma	OMBRABULIN (AVE... Placebo	18 Years -	Sanofi
A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor	NCT01063946	Neoplasms, Mali...	Ombrabulin (AVE...	18 Years -	Sanofi
A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor	NCT01063946	Neoplasms, Mali...	Ombrabulin (AVE...	18 Years -	Sanofi

Spots Global Cancer Trial Database for ombrabulin (ave8062)