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INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer (INOVATYON)

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ClinicalTrials.gov Identifier: NCT01379989
Recruitment Status : Active, not recruiting
First Posted : June 23, 2011
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
PharmaMar
Averion International Corporation
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Tracking Information
First Submitted Date  ICMJE June 1, 2011
First Posted Date  ICMJE June 23, 2011
Last Update Posted Date May 14, 2019
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2011)
Overall survival (OS) [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled ]
This is an event driven study. The study will continue until 442 events have occurred.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • Progression Free Survival (PFS) [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    PFS will be measured from the date of randomization to the date of documented PD or death (regardless of cause of death).
  • Objective RR [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    Objective RR will be the best response obtained in any evaluation according to RECIST 1.1
  • CA-125 serological response [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    CA-125 serological response will be the best response obtained in each arm
  • Duration of Response [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    Duration of response: will be calculated from the date of first documentation of response (CR or partial response [PR], whichever occurs first) to the date of documented PD or death.
  • Time to subsequent chemotherapy administration [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    The time from randomization to subsequent chemotherapy counted from the administration of subsequent chemotherapy will be evaluated as an exploratory analysis.
  • OS for Subsequent chemotherapies [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    the overall survival counted from the administration of subsequent chemotherapy until death
  • PFS for the Subsequent Chemotherapies [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    the progression free survival counted from the administration of subsequent chemotherapy untill disease progression or death whichever occurs first
  • Frequency of serious adverse events (SAEs) [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    Number of SAEs for each randomization arm
  • QoL according to the EORTC QLQ-C30 and QLQ-OV28 [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    Two PRO instruments will be administered in this study: the EORTC QLQ-C30 and QLQ-OV28.PRO instruments will be completed by the patient at screening (before randomization) and within four weeks after the 6th cycle or at the time of progression, whichever occurs first.
  • Best response to each Subsequent chemotherapy line [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    The best response obtained to each Subsequent chemotherapy line calculated as frequency of patients with CR, PR, SD or PD.
  • Frequency of toxicities, graded according to the NCI-CTAE version 4.0 [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    Clinical and laboratory toxicities
  • Frequency of toxicities leading to dose delays [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    Clinical and laboratory toxicities
  • Frequency of toxicities leading to dose modifications [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    Clinical and laboratory toxicities
  • Frequency of toxicities leading to treatment discontinuation [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    Clinical and laboratory toxicities
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2011)
  • Progression Free Survival (PFS) [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    PFS will be measured from the date of randomization to the date of documented PD or death (regardless of cause of death).
  • Objective RR [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    Objective RR will be the best response obtained in any evaluation according to RECIST 1.1
  • CA-125 serological response [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    CA-125 serological response will be the best response obtained in each arm
  • Duration of Response [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    Duration of response: will be calculated from the date of first documentation of response (CR or partial response [PR], whichever occurs first) to the date of documented PD or death.
  • Time to subsequent chemotherapy administration [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    The time from randomization to subsequent chemotherapy counted from the administration of subsequent chemotherapy will be evaluated as an exploratory analysis.
  • OS for Subsequent chemotherapies [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
  • PFS for the Subsequent Chemotherapies [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
  • Frequency of serious adverse events (SAEs) [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
  • QoL according to the EORTC QLQ-C30 and QLQ-OV28 [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
    Two PRO instruments will be administered in this study: the EORTC QLQ-C30 and QLQ-OV28.PRO instruments will be completed by the patient at screening (before randomization) and within four weeks after the 6th cycle or at the time of progression, whichever occurs first.
  • Best response to every Subsequent chemotherapy [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
  • Frequency of toxicities, graded according to the NCI-CTAE version 4.0 [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
  • Frequency of toxicities leading to dose delays [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
  • Frequency of toxicities leading to dose modifications [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
  • Frequency of toxicities leading to treatment discontinuation [ Time Frame: This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled, at the same time points of the Primary Endpoint ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer
Official Title  ICMJE Phase III International, Randomized Study of Trabectedin Plus Pegylated Liposomal Doxorubicin (PLD) Versus Carboplatin Plus PLD in Patients With Ovarian Cancer Progressing Within 6-12 Months of Last Platinum
Brief Summary The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients.
Detailed Description

Patients will be randomised to:

Arm A: PLD 30 mg/m2 and carboplatin AUC 5; Arm B: PLD 30 mg/m2 and trabectedin 1.1 mg/m2. Patients' characteristics: patients over 18 years of age with advanced, progressive ovarian cancer 6-12 months after completion of first line or second line treatment with platinum-based chemotherapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Carboplatin
    Carboplatin AUC 5
    Other Name: Carboplatin generic
  • Drug: Pegylated Lipoxomal Doxorubicin (PLD)
    PLD 30 mg/m² i.v.
    Other Name: Caelyx
  • Drug: Trabectedin
    trabectedin 1.1 mg/m2 3-hour i.v. infusion on Day 1 every 3 weeks. The use of central venous access is strongly recommended.
    Other Name: Yondelis
Study Arms  ICMJE
  • Active Comparator: Carboplatin plus PLD
    Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/ m2 followed by carboplatin AUC 5.
    Interventions:
    • Drug: Carboplatin
    • Drug: Pegylated Lipoxomal Doxorubicin (PLD)
  • Experimental: Trabectedin plus PLD
    Pegylated Lipoxomal Doxorubicin (PLD) 30 mg/m2 infusion followed by trabectedin 1.1 mg/m2 infusion.
    Interventions:
    • Drug: Pegylated Lipoxomal Doxorubicin (PLD)
    • Drug: Trabectedin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2011)
588
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female, aged ≥ 18 years
  2. Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer
  3. Progression free interval between six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinum-based chemotherapy until the date of progression confirmation through radiologic imagery). Patients may have received up to two platinum-based chemotherapy lines, of which at least one must have contained a taxane
  4. Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MRI), computed tomography (CT) scan, or PET/CT scan at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions.
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  6. Estimated life expectancy ≥ 12 weeks
  7. Patients must be accessible for treatment and follow-up
  8. Adequate organ function within 14 days prior to first cycle as evidenced
  9. Patients must be able to receive dexamethasone or its equivalent, which is required if randomly assigned to treatment with trabectedin plus PLD
  10. Informed consent of the patient

Exclusion Criteria:

  1. Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
  2. Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months or > 12 months from the last dose of platinum
  3. Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
  4. Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0
  5. Myocardial infarct within six months before enrolment, New York Association (NYHA) Class II or worse heart failure (Appendix 1. The New York Heart Association), uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  6. History of liver disease
  7. Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
  8. Breastfeeding women and women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile)
  9. Prior exposure to trabectedin
  10. Prior resistance to anthracyclines or PLD defined as a progression during anthracycline-based chemotherapy or a recurrence within 6 months from its ending
  11. Prior severe PLD related toxicity
  12. Prior exposure to cumulative doses of doxorubicin >400mg/m2 or epirubicin >720mg/m2
  13. Treatment with any investigational product within 30 days prior to inclusion in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   Finland,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01379989
Other Study ID Numbers  ICMJE ET-D-009-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mario Negri Institute for Pharmacological Research
Study Sponsor  ICMJE Mario Negri Institute for Pharmacological Research
Collaborators  ICMJE
  • PharmaMar
  • Averion International Corporation
Investigators  ICMJE
Principal Investigator: Nicoletta Colombo, MD European Institute of Oncology (I.E.O), Milan, Italy
PRS Account Mario Negri Institute for Pharmacological Research
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP