Recurrent Ovarian CancerNIS-OvaYondNCT01869400
An Observational Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
An observational study of Recurrent Ovarian Cancer, run by PharmaMar, Spain at 2 sites in Germany.
Trial summary
Clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined patient groups, which are not representative for the whole patient population. Especially elderly patients and patients with co-morbidities are underrepresented in clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Cancer
- Type of treatment
- Injection or infusion
- How many people
- 83 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2013to Feb 2017
- 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: hospitales and medical practices in Germany
Who may be able to join
- Women age >18, no upper limit
- Patients with relapsed platinum-sensitive ovarian cancer
- Before inclusion in the NIS written informed consent must be given
Who cannot join
- According to summary of product characteristics
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Praxis und Tagesklinik für gynäkologische Onkologie
Ebersberg, Bavaria, 85567
Diakoniekrankenhaus, Gynäkologie und Geburtshilfe
Rotenburg (Wümme), Lower Saxony, 27356
About this study
Official title: An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
Clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined patient groups, which are not representative for the whole patient population.
Especially elderly patients and patients with co-morbidities are underrepresented in clinical trials.
This non-interventional study will examine the efficiency and toxicity of the Yondelis® + PLD combination therapy in a general patient population to evaluate if the data collected in the clinical trials can be assigned to a general patient population.
Read the detailed description
Yondelis® (trabectedin) was approved (in combination with PLD) in the European community in December 2009 for the treatment of platinum-sensitive ovarian cancer relapse. Based on the outcomes of study OVA-301, this non-interventional study will investigate the role of a platinum-free treatment regimen in patients with progressive ovarian cancer relapsing > 6 months after completing previous platinum-based chemotherapy. In particular, this study aims at collecting the "real-life" data with regard to the response and the influence of the mentioned therapy on the "tumor related events", to objectify the value of palliative care.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Yondelis-Pegylated liposomal Doxorubicin | 30 mg/m² PLD i.v. followed by 1.1 mg/m² Yondelis® i.v. 3 h, q3weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability data of the study therapy
Number of patients with adverse events
Measured: during Yondelis-PLD-therapy
Secondary outcomes (6)
"Real life data" - clinical and / or serological (CA 125) response and Stable disease rates
Number of patients with CR, PR, SD as best response
Measured: till one year after last date of Yondelis-PLD-therapy
Treatment duration
Time between first and last cycle of each patient
Measured: during Yondelis-PLD-therapy
Observation of the number of the therapy cycles applied
Number of applied therapy cycles
Measured: during Yondelis-PLD-therapy
Time to next treatment
Date from last Yondelis-PLD-treatment to date of next treatment
Measured: 1 Year after last Yondelis-PLD-Therapy
Progression free survival
Difference between date of first documentation of "PD" and the date of first Yondelis® + PLD application
Measured: till one year after last date of Yondelis-PLD-therapy
Duration of response
Time in months from first assessment of CR or PR until the first date of PD or death.
Measured: till one year after last date of Yondelis-PLD-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar, Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingo Runnebaum, Prof. Dr., Study chair, Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869400
- Sponsor's protocol ID
- OvaYond
- Acronym
- NIS-OvaYond
- Status last verified
- Apr 2018
- First submitted
- 15 May 2013
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01869400
- Acronym / sponsor ID
- NIS-OvaYond / OvaYond
- Conditions
- Recurrent Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- PharmaMar, SpainIndustry (pharma, biotech, devices)
- Study start
- Apr 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 5 Jun 2013 (estimated)
- 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.
Clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined patient groups, which are not representative for the whole patient population.
Especially elderly patients and patients with co-morbidities are underrepresented in clinical trials.
This non-interventional study will examine the efficiency and toxicity of the Yondelis® + PLD combination therapy in a general patient population to evaluate if the data collected in the clinical trials can be assigned to a general patient population.
Detailed description
Yondelis® (trabectedin) was approved (in combination with PLD) in the European community in December 2009 for the treatment of platinum-sensitive ovarian cancer relapse. Based on the outcomes of study OVA-301, this non-interventional study will investigate the role of a platinum-free treatment regimen in patients with progressive ovarian cancer relapsing > 6 months after completing previous platinum-based chemotherapy. In particular, this study aims at collecting the "real-life" data with regard to the response and the influence of the mentioned therapy on the "tumor related events", to objectify the value of palliative care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yondelis-Pegylated liposomal Doxorubicin | – | –30 mg/m² PLD i.v. followed by 1.1 mg/m² Yondelis® i.v. 3 h, q3weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitales and medical practices in Germany
Key inclusion criteria (3 listed)
- Women age >18, no upper limit
- Patients with relapsed platinum-sensitive ovarian cancer
- Before inclusion in the NIS written informed consent must be given
Key exclusion criteria (1 listed)
- According to summary of product characteristics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
safety and tolerability data of the study therapy
Time frame: during Yondelis-PLD-therapy
Number of patients with adverse events
6 secondary outcomes
"Real life data" - clinical and / or serological (CA 125) response and Stable disease rates
Time frame: till one year after last date of Yondelis-PLD-therapy
Treatment duration
Time frame: during Yondelis-PLD-therapy
Observation of the number of the therapy cycles applied
Time frame: during Yondelis-PLD-therapy
Time to next treatment
Time frame: 1 Year after last Yondelis-PLD-Therapy
Progression free survival
Time frame: till one year after last date of Yondelis-PLD-therapy
Duration of response
Time frame: till one year after last date of Yondelis-PLD-therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Ingo Runnebaum, Prof. Dr. study chair
Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Ovarian Cancer, run by PharmaMar, Spain at 2 sites in Germany.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability data of the study therapy (time frame: during Yondelis-PLD-therapy). 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 6 Apr 2018.