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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01332656
First received: April 7, 2011
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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

Condition Intervention Phase
Ovarian Cancer Recurrent
Drug: Ombrabulin (AVE8062)
Drug: Placebo
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Objective Response Rate (RR) [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Ombrabulin, Paclitaxel and Carboplatin
Drug: Ombrabulin (AVE8062)

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Paclitaxel

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Carboplatin

Pharmaceutical form:solution

Route of administration: intravenous

Placebo Comparator: Arm B
Placebo, Paclitaxel and Carboplatin
Drug: Placebo

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Paclitaxel

Pharmaceutical form:solution

Route of administration: intravenous

Drug: Carboplatin

Pharmaceutical form:solution

Route of administration: intravenous


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Signed informed consent.
  2. At least 18 years of age.
  3. Histological and/or cytological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma.
  4. 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.
  5. 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.
  6. 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.
  7. ECOG performance status ≤2
  8. Life expectancy more than 12 weeks

Exclusion criteria:

  1. History of uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis.
  2. 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.
  3. 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.
  4. 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.
  5. Pregnancy or breast-feeding. Positive serum or urine pregnancy test prior to randomization.
  6. 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.
  7. 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.
  8. Urine protein-creatinin ratio (UPCR) >1 (urinanalysis on morning spot urine) or proteinuria >500 mg/24h
  9. Pre-existing peripheral neuropathy > grade 1 according to the NCI CTCAE V.4.03
  10. Pre-existing hearing impairment > grade 1
  11. Known hypersensitivity due to taxanes and /or polysorbate 80 or any other compound/excipients of the study drug combination
  12. Discontinuation of previous treatment with paclitaxel and/or carboplatin for toxicity reason
  13. Other serious illness or medical conditions such as (but not restricted):

    • Active infection
    • Superior vena cava syndrome
    • Pericardial effusion requiring intervention (drainage)
  14. Documented medical history of myocardial infarction, documented angina pectoris, arrhythmia especially severe conduction disorder such as second or third-degree atrioventricular block, stroke, or history of arterial or venous thrombo-embolism within the past 6 months still requiring anticoagulants.
  15. Cardiac Troponin at levels that exceed the normal ranges values defined by the laboratory
  16. Uncontrolled hypertension within 3 months prior to study treatment or patient with organ damage related to hypertension.
  17. Patient with LVEF value lower than institution inferior normal limit, evaluated by echocardiography or angiocardiography
  18. 12-lead ECG:

    • Infarction Q-wave,
    • ST segment depression or elevation ≥1 mm in at least 2 contiguous leads
    • QT/QTc-Time > 450ms

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332656

  Show 48 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01332656     History of Changes
Other Study ID Numbers: EFC10260, 2010-024631-16, U1111-1118-5437
Study First Received: April 7, 2011
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 23, 2014