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

NCT01332656 | Completed Phase 2

• 3 other identifiers: EFC102602010-024631-16U1111-1118-5437
• Study Type: interventional
• Target: 154
• Locations: 10 countries
• Sites: 38

Brief Summary

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

Conditions

Ovarian Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  approximately 24 months

Secondary Outcomes (2)

• Overall Survival (OS)

  approximately 24 months

• Objective Response Rate (RR)

  approximately 24 months

Study Arms (2)

Arm A

EXPERIMENTAL

Ombrabulin, Paclitaxel and Carboplatin

Drug: Ombrabulin (AVE8062); Drug: Paclitaxel; Drug: Carboplatin

Arm B

PLACEBO COMPARATOR

Placebo, Paclitaxel and Carboplatin

Drug: Placebo; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Ombrabulin (AVE8062) DRUG

Pharmaceutical form:solution Route of administration: intravenous

Arm A

Placebo DRUG

Pharmaceutical form:solution Route of administration: intravenous

Arm B

Paclitaxel DRUG

Pharmaceutical form:solution Route of administration: intravenous

Arm A; Arm B

Carboplatin DRUG

Pharmaceutical form:solution Route of administration: intravenous

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• At least 18 years of age.
• Histological and/or cytological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma.
• Completion of maximum one previous line of chemotherapy containing a platinum agent. Neoadjuvant/adjuvant treatment that include a surgical procedure will be considered as one line if platinum-based.
• Documented sensitivity to a platinum based chemotherapy regimen. "Platinum-sensitivity" is defined by a relapse more than 6 months after last dose of platinum-based chemotherapy.
• Measurable progressive disease: Measurable disease (as defined by RECIST 1.1) is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be at least 10mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be \>15 mm in short axis when measured by CT or MRI. In case of a single measurable lesion, this should not be previously irradiated.
• ECOG performance status ≤2
• Life expectancy more than 12 weeks

You may not qualify if:

• History of uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis.
• History of another neoplasm. Adequately treated basal cell or squamous skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for \>5 years are allowed.
• Participation in another clinical trial and any concurrent treatment with any investigational drug or anti-tumor therapy or radiotherapy within 21 days prior to randomization (or 28 days for those therapies with a schedule of administration every 4 weeks and except for nitrosoureas, mitomycin which may not be used up to 6 weeks prior to the first cycle provided that patients do not have residual signs of any toxicity). No wash-out is required for hormonotherapy which has to be discontinued before the first cycle.
• Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results.
• Pregnancy or breast-feeding. Positive serum or urine pregnancy test prior to randomization.
• Patient with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" will be based on the investigator's judgment. Effective method of contraception should also be adapted to local regulations.
• Inadequate organ function including: neutrophils \<1.5 x 10\^9/L; platelets \<100 x 10\^9/L; creatinine ≥ 1.5 ULN. If creatinine ≥ ULN, the calculated creatinine clearance should be ≥ 60 ml/min (as per Cockcroft Formula). Total bilirubin not within normal limit and ALT/AST/AP \>2.5 times the upper normal limits of the institutional norms. An increase of AP up to grade 2 would be accepted only if this increase is related to the presence of bone metastases. Bone specific isoenzyme AP should be evaluated.
• Urine protein-creatinin ratio (UPCR) \>1 (urinanalysis on morning spot urine) or proteinuria \>500 mg/24h
• Pre-existing peripheral neuropathy \> grade 1 according to the NCI CTCAE V.4.03
• Pre-existing hearing impairment \> grade 1
• Known hypersensitivity due to taxanes and /or polysorbate 80 or any other compound/excipients of the study drug combination
• Discontinuation of previous treatment with paclitaxel and/or carboplatin for toxicity reason
• Other serious illness or medical conditions such as (but not restricted):
• Active infection
• Superior vena cava syndrome

Sponsors & Collaborators

• Sanofi: lead

Study Sites (38)

Investigational Site Number 840007

Burbank, California, 91505, United States

Location

Investigational Site Number 840001

New Haven, Connecticut, 06510, United States

Location

Investigational Site Number 840202

Fort Meyers, Florida, 33919, United States

Location

Investigational Site Number 840009

Atlanta, Georgia, 30342, United States

Location

Investigational Site Number 840002

Boston, Massachusetts, 02114, United States

Location

Investigational Site Number 056002

Haine-Saint-Paul, 7100, Belgium

Location

Investigational Site Number 056005

Kortrijk, 8500, Belgium

Location

Investigational Site Number 056001

Leuven, 3000, Belgium

Location

Investigational Site Number 056003

Namur, 5000, Belgium

Location

Investigational Site Number 203003

Nový Jičín, 74101, Czechia

Location

Investigational Site Number 203002

Olomouc, 77520, Czechia

Location

Investigational Site Number 203001

Prague, 12808, Czechia

Location

Investigational Site Number 203004

Zlín, 76275, Czechia

Location

Investigational Site Number 250006

Bordeaux, 33076, France

Location

Investigational Site Number 250004

Caen, 14076, France

Location

Investigational Site Number 250001

Lyon, 69373, France

Location

Investigational Site Number 250002

Paris, 75181, France

Location

Investigational Site Number 250003

Villejuif, 94805, France

Location

Investigational Site Number 276001

München, 81737, Germany

Location

Investigational Site Number 380004

Genova, 16132, Italy

Location

Investigational Site Number 380003

Milan, 20141, Italy

Location

Investigational Site Number 380001

Roma, 00168, Italy

Location

Investigational Site Number 616002

Krakow, 31-115, Poland

Location

Investigational Site Number 616004

Poznan, 60-569, Poland

Location

Investigational Site Number 616003

Rybnik, 44-200, Poland

Location

Investigational Site Number 616005

Warsaw, 02-061, Poland

Location

Investigational Site Number 616001

Warsaw, 02-781, Poland

Location

Investigational Site Number 643002

Moscow, 115478, Russia

Location

Investigational Site Number 643003

Moscow, 115478, Russia

Location

Investigational Site Number 643001

Moscow, 129128, Russia

Location

Investigational Site Number 643004

Saint Petersburg, 194291, Russia

Location

Investigational Site Number 724002

Barcelona, 08035, Spain

Location

Investigational Site Number 724003

Madrid, 28040, Spain

Location

Investigational Site Number 724001

Madrid, 28046, Spain

Location

Investigational Site Number 804003

Dnipropetrovsk, 49102, Ukraine

Location

Investigational Site Number 804005

Donetsk, 83092, Ukraine

Location

Investigational Site Number 804004

Kharkiv, 61070, Ukraine

Location

Investigational Site Number 804002

Lviv, 70031, Ukraine

Location

MeSH Terms

Interventions

AC 7700; Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 21, 2015

Record last verified: 2015-11

Locations

ES (3); IT (3); US (5); RU (4); FR (5); CZ (4); DE (1); UA (4); PL (5); BE (4)