Ovarian CancerRenaissanceNCT03446495
An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer
An observational study of Ovarian Cancer, run by Suriya Yessentayeva at 10 sites in Kazakhstan.
Trial summary
This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Trabectedin + PLD
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 10 sitesKazakhstan
- Study dates
- 28 Mar 2017to 20 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with relapsed ovarian cancer
Who may be able to join
- Age>18
- Histologically proven epithelial ovarian cancer
- ECOG 0-1
- Partially platinum sensitive relapsed ovarian cancer: platinum-free interval 6 -12 months
- With 1-2 or more cycles on trabectedin treatment at the recommended dose of 1.1mg/m2 q3w 3hr infusion in combination of PLD at 30mg/ml with appropriate pre-medication
- Prior treatment with 1 or more chemotherapy regimen
Who cannot join
- Platinum resistant disease: PFI < 6 months (progression within six months after first-line platinum-based chemotherapy)
- Unwilling or unable to have a central venous catheter
- Patients with hepatic impairment (Patients with elevated bilirubin)
- Patients with renal impairment (Patients with serum creatinine >1.5 mg/dL)
- Patients with hematologic impairment (baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3)
- Patients with serious impaired cardiac function (patients with cardiac disease and with reduction of the QRS complex)
- AIDS-related Kaposi's sarcoma
- Lactation or pregnancy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Kazakhstan10 sites, 10 recruiting
- Recruiting
Almaty oncological center
Almaty
Rinat Baituganov, PhD, +7 (727) 382 61 60, almaty.onco@mail.ru
Rinat Baituganov, PhD
- Recruiting
Almaty regional oncological dispensary
Almaty
Sayakhat Olzhaev, PhD, +77273993881, arod_priem@mail.ru
Sayakhat Olzhaev, PhD
- Recruiting
Kazakh institute of oncology and radiology
Almaty
Dilara Kaidarova, Academician, + 7 727 292 00 61, admin@ncc.org.kz
Dilara Kaidarova, academician
- Recruiting
Kazakh institute of oncology and radiology
Almaty
Oxana Shatkovskaya, PhD, +77014147124, 1972arty@mail.ru
Oxana Shatkovskaya, PhD
- Recruiting
Astana Oncology Center
Astana
Mukhtar Tuleutaev, PhD, +77172560073
Mukhtar Tuleutaev, PhD
- Recruiting
Kyzylorda regional Oncological center
Kyzylorda
Saken Sergaziyev, PhD, +77242235468, onkolog_kzo@mail.ru
Saken Sergaziyev, PhD
- Recruiting
West Kazakhstan regional oncology dispensary
Oral
Esengeldy Rabaev, PhD
Esengeldy Rabaev, PhD
- Recruiting
North Kazakhstan Regional Oncology Center
Petropavl
Ermek Abdrimov, PhD, +77152463201, sko.ood@mail.ru
Ermek Abdrimov, PhD
- Recruiting
South Kazakhstan regional oncologic dispensary
Shymkent
Dauranbek Arybzhanov, PhD, +77252221904, onco-shm@mail.ru
Dauranbek Arybzhanov, ЗрВ
- Recruiting
East Kazakhstan Regional Oncology Dispensary
Ust-Kamenogorsk
Gulmira Sagidullina, PhD, +77112705976, vkood_poliklinika@mail.ru
Gulmira Sagidullina, PhD
About this study
Official title: A Non-interventional, Multicenter Study of the Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer
This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan.
- Conditions
- Ovarian Cancer
- Being tested
- Trabectedin + PLD
- Keywords
- ovarian cancer, trabectedin, recurrent ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabectedin + PLDDrug
Combination of Trabectedin + PLD: PLD 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Trabectedin + PLD | Trabectedin + PLD according to SmPC Receives: Drug: Trabectedin + PLD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST V 1.1).
Measured: Patient will be followed during 37 weeks
Secondary outcomes (2)
Progression-Free Survival (PFS)
PFS is defined as the time from the 1st treatment cycle until objective tumor progression or death
Measured: Patient will be followed during 37 weeks
Safety according to CTCAE v4.0
To assess patient safety and the tolerance of trabectedin + PLD
Measured: Patient will be followed during 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start28 Mar 2017
- Primary completion20 Mar 2019 (estimated)
- Study completion20 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suriya Yessentayeva
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor-investigator, Suriya Yessentayeva, Scientific Medical Society, Kazakhstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446495
- Sponsor's protocol ID
- R279741OVC4001
- Acronym
- Renaissance
- Status last verified
- Feb 2018
- First submitted
- 13 Feb 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Multicenter Study of the Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03446495
- Acronym / sponsor ID
- Renaissance / R279741OVC4001
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, trabectedin, recurrent ovarian cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suriya YessentayevaUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 20 Mar 2019 (estimated)
- Study completion
- 20 May 2019 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trabectedin + PLD | – | Drug: Trabectedin + PLDTrabectedin + PLD according to SmPC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with relapsed ovarian cancer
Key inclusion criteria (6 listed)
- Age>18
- Histologically proven epithelial ovarian cancer
- ECOG 0-1
- Partially platinum sensitive relapsed ovarian cancer: platinum-free interval 6 -12 months
- With 1-2 or more cycles on trabectedin treatment at the recommended dose of 1.1mg/m2 q3w 3hr infusion in combination of PLD at 30mg/ml with appropriate pre-medication
Key exclusion criteria (8 listed)
- Platinum resistant disease: PFI < 6 months (progression within six months after first-line platinum-based chemotherapy)
- Unwilling or unable to have a central venous catheter
- Patients with hepatic impairment (Patients with elevated bilirubin)
- Patients with renal impairment (Patients with serum creatinine >1.5 mg/dL)
- Patients with hematologic impairment (baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trabectedin + PLDCombination of Trabectedin + PLD: PLD 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks. | Drug | Trabectedin + PLD |
Primary outcome
Objective Response Rate (ORR)
Time frame: Patient will be followed during 37 weeks
ORR will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST V 1.1).
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Patient will be followed during 37 weeks
Safety according to CTCAE v4.0
Time frame: Patient will be followed during 37 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Suriya Yessentayeva at 10 sites in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suriya Yessentaeva, PhD (+77077942910, surya_esentay@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Patient will be followed during 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.