Inovatyon second-line chemotherapy ovarian cancer
| ISRCTN | ISRCTN55984729 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55984729 |
| EudraCT/CTIS number | 2010-022949-17 |
| ClinicalTrials.gov number | NCT01379989 |
| Secondary identifying numbers | 10836 |
- Submission date
- 31/10/2011
- Registration date
- 31/10/2011
- Last edited
- 08/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Sam Ballantyne
Scientific
Scientific
Guy's and St Thomas' Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
| samb@oclinical.com |
Study information
| Study design | Randomised interventional treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | INOVATYON |
| Study objectives | No data are available comparing trabectedin + PLD to a platinum-based regimen. Based on data from OVA-301 and CALYPSO the proposed INOVATYON trial will investigate the role of a non-platinum combination for the treatment of ovarian cancer patients relapsing between six and 12 months after last platinum-based chemotherapy 1. Does the combination of trabectedin and PLD prolong overall survival over carboplatin + PLD? 2. Progression Free Survival, response rate, safety profile, quality of life,Time from randomization to subsequent chemotherapy, response rate and progression free survival after subsequent therapies, overall survival counted from the administration of subsequent chemotherapy Sub study (Italy Only) Pharmacokinetic analyses in plasma and ascites in a subset of patients receiving trabectedin and PLD 1. To demonstrate that the combination of trabectedin (Yondelis®) and pegylated liposomal doxorubicin (PLD) prolongs overall survival (OS) over carboplatin and PLD in patients with relapsed ovarian cancer progressing within 6-12 months after end of last platinum. 2. To evaluate the time from randomization to subsequent chemotherapy and the overall survival counted from the administration of subsequent chemotherapy. 2.1. To evaluate serological response of CA-125 in each arm. 2.2. To compare the quality of life (QoL) in each arm using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30) and the Quality of Life Questionnaire-OV28 (QLQ-OV28). 2.3. To compare safety profile, progression free survival (PFS), objective response rate (ORR), the type and length of remission (response rate and PFS) after subsequent therapies following each of the two combinations. 2.4. Sub-study in selected centers (ITALY ONLY): To perform pharmacokinetic (PK) analyses in both plasma and ascites in a subset of patients receiving trabectedin and PLD |
| Ethics approval(s) | First MREC, 04/10/2011, ref: 11/LO/1261 |
| Health condition(s) or problem(s) studied | Gynaecological cancer, ovarian cancer |
| Intervention | Yondelis & PLD versus Carboplatin & PLD Patients are either given trabectedin (Yondelis®) and pegylated liposomal doxorubicin (PLD) or carboplatin and PLD |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Carboplatin, Pegylated Liposomal Doxorubicin (PLD), Trabectedin (Yondelis®) |
| Primary outcome measure | Demonstrate that the combination of trabectedin (Yondelis®) and pegylated liposomal doxorubicin |
| Secondary outcome measures | 1. CA-125 response 2. To evaluate serological response of CA-125 in each arm 3. Quality of life 4. To compare the quality of life (QoL) in each arm using the European Organization for Research 5. Safety Profile 6. To compare safety profile, progression free survival (PFS), objective response rate (ORR) Sub study (Italy only): 1. To perform pharmacokinetic (PK) analyses in both plasma 2. Time to subsequent chemotherapy 3. To evaluate the time from randomization to subsequent chemotherapy and the overall survival counted |
| Overall study start date | 01/05/2011 |
| Completion date | 01/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 588. 442 events and about 588 patients are needed |
| Total final enrolment | 617 |
| Key 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 by: 8.1. Peripheral blood counts and serum chemistry values: 8.1.1. Hemoglobin ³ 9 g/dl 8.1.2. Absolute neutrophil count (ANC) ³ 1,500/ml 8.1.3. Platelet count ³ 100,000/ml 8.1.4. Estimated glomerular filtration rate > 60 ml/min according to the Cockroft-Gault formula 8.1.5. Creatine phosphokinase (CPK) = 2.5 x ULN 8.2. Hepatic function variables: 8.2.1. Total bilirubinULN 8.2.2. Total alkaline phosphatase 2.5 ULN (consider hepatic isoenzymes 5-nucleotidase if the elevation could be osseous in origin) 8.2.3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be £ 2.5 x ULN 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 |
| Key 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 YorkHeart Association (NYHA) Class II or worse heart failure, 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 14. Patients with known hypersensitivity to Trabectedin and any of its excipients or yellow fever vaccine 15. Patients with concurrent serious or uncontrolled infection 16. Patients in need of yellow fever vaccine while on study chemotherapy |
| Date of first enrolment | 01/05/2011 |
| Date of final enrolment | 01/12/2013 |
Locations
Countries of recruitment
- Denmark
- England
- Finland
- Germany
- Italy
- Spain
- United Kingdom
Study participating centre
Guy's and St Thomas' Hospital
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Mario Negri Gynecological Oncology Group - MaNGO (Italy)
Research organisation
Research organisation
[Istituto di Ricerche Farmacologiche "Mario Negri"]
Via La Masa
Milano
19 - 20156
Italy
| Website | http://www.marionegri.it/mn/en/index.html |
|---|---|
"ROR" |
https://ror.org/01qd3xc93 |
Funders
Funder type
Industry
Pharma Mar (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available later |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | 16/07/2021 | 20/07/2021 | No | Yes | |
| Results article | outcome results | 09/02/2023 | 08/03/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/03/2023: The following changes have been made to the study record:
1. Publication reference added.
2. Acronym added.
3. Total final enrolment added.
20/07/2021: Cancer Research UK lay results summary link added.
21/09/2016: Verifying study status with principal investigator.
