Ovarian NeoplasmsPhase 2NCT01121406
BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer
A Phase 2 study testing Paclitaxel, Gemcitabine and Topotecan in people with Ovarian Neoplasms, run by Boehringer Ingelheim at 31 sites in 5 countries.
Trial summary
This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Paclitaxel, Gemcitabine and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 31 sitesin 5 countries
- Study dates
- Apr 2010to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Confirmed recurrent epithelial ovarian carcinoma, peritoneal carcinoma or fallopian tube carcinoma.
- Platinum resistant or platinum refractory disease.
- Eastern Collaborative Oncology Group performance status < = 2.
- Life expectancy > = 3 months.
- At least one measurable lesion (Response Evaluation Criteria In Solid Tumours version 1.1).
- Adequate hepatic, renal and bone marrow functions.
- signed written informed consent prior to admission to the study.
Who cannot join
- Contre-indications for cytotoxic treatment according to the Summary of Product Characteristics (Arm B).
- Clinical evidence of active brain metastasis or leptomeningeal involvement.
- Other malignancy currently requiring active therapy.
- QTc prolongation according to Fridericia formula deemed clinically relevant by the investigator (e.g., congenital long QT syndrome, QTc according to Fridericia formula > 470 ms).
- Hypersensitivity to one of the trial drugs or the excipients.
- Serious illness or concomitant non- oncological disease.
- Systemic anticancer therapy within 4 weeks before the start of the study.
- Evidence of ileus sor sub ileus.
Trial locations and contacts
31 sites in 5 countries.
31 sites in 5 countries
France15 sites
1230.18.3321A Boehringer Ingelheim Investigational Site
Angers
1230.18.3307A Boehringer Ingelheim Investigational Site
Bordeaux
1230.18.3301A Boehringer Ingelheim Investigational Site
Caen
1230.18.3322A Boehringer Ingelheim Investigational Site
Lille
1230.18.3313A Boehringer Ingelheim Investigational Site
Lyon
1230.18.3312A Boehringer Ingelheim Investigational Site
Nantes
1230.18.3308A Boehringer Ingelheim Investigational Site
Nice
1230.18.3302A Boehringer Ingelheim Investigational Site
Paris
1230.18.3314A Boehringer Ingelheim Investigational Site
Paris
1230.18.3309A Boehringer Ingelheim Investigational Site
Pierre-Bénite
1230.18.3305A Boehringer Ingelheim Investigational Site
Reims
1230.18.3320A Boehringer Ingelheim Investigational Site
Saint-Brieuc
1230.18.3311A Boehringer Ingelheim Investigational Site
Strasbourg
1230.18.3310A Boehringer Ingelheim Investigational Site
Toulouse
1230.18.3315A Boehringer Ingelheim Investigational Site
Vandœuvre-lès-Nancy
Spain7 sites
1230.18.34006 Boehringer Ingelheim Investigational Site
Badalona
1230.18.34001 Boehringer Ingelheim Investigational Site
Barcelona
1230.18.34005 Boehringer Ingelheim Investigational Site
Barcelona
1230.18.34007 Boehringer Ingelheim Investigational Site
Girona
1230.18.34004 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1230.18.34002 Boehringer Ingelheim Investigational Site
Madrid
1230.18.34003 Boehringer Ingelheim Investigational Site
Madrid
Belgium4 sites
1230.18.32003 Boehringer Ingelheim Investigational Site
Brussels
1230.18.32004 Boehringer Ingelheim Investigational Site
Edegem
1230.18.32002 Boehringer Ingelheim Investigational Site
Ghent
1230.18.32001 Boehringer Ingelheim Investigational Site
Leuven
Sweden3 sites
1230.18.46005 Boehringer Ingelheim Investigational Site
Linköping
1230.18.46001 Boehringer Ingelheim Investigational Site
Stockholm
1230.18.46003 Boehringer Ingelheim Investigational Site
Uppsala
Slovakia2 sites
1230.18.42101 Boehringer Ingelheim Investigational Site
Bratislava
1230.18.42103 Boehringer Ingelheim Investigational Site
Poprad
About this study
Official title: Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy
This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer.
100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.
Read more
Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.
Others endpoints: biomarkers and pharmacogenetics analysis (optional)
- Conditions
- Ovarian Neoplasms
- Being tested
- Paclitaxel, Gemcitabine, Topotecan, Pegylated liposomal doxorubicin (PLD), BI 6727
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Patients receive paclitaxel in a 4 week schedule
GemcitabineDrug
Patients receive gemcitabine in a 3 week schedule
TopotecanDrug
Patients receive topotecan in 3 or 4 week schedule
Pegylated liposomal doxorubicin (PLD)Drug
Patients receive PLD in a 4 week schedule
BI 6727Drug
Patients receive BI 6727 infusion every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| BI 6727 | Experimental | Patients receive BI 6727 infusion every 3 weeks Receives: Drug: BI 6727 |
| Cytotoxic | Active comparator | At the investigator discretion, patient will receive one of the following cytotoxics: topotecan, paclitaxel, gemcitabine or liposomal doxorubicin Receives: Drug: Paclitaxel; Drug: Gemcitabine; Drug: Topotecan; Drug: Pegylated liposomal doxorubicin (PLD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).
Measured: Week 24
Secondary outcomes (26)
Progression Free Survival (PFS)
Progression-free survival of a patient was based on the investigator's assessment; it was defined as the number of days from the date of randomisation until the date of either disease progression or death from any cause, whichever occurred first.
Definition of disease progression according to RECIST version 1.1; Patients with measurable tumour lesions at baseline, Target-lesions: at least a 20% increase in the sum of diameters of target lesions, the sum of diameters must also demonstrate an absolute increase of at least 5 mm,taking as reference the smallest sum on study, or appearance of 1 or more new lesions.
Non-target lesions: unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions Patients with non-measurable tumour lesions at baseline, Non-target lesions: requires unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions
Measured: From randomization until disease progression, death or study discontinuation; Up to 213 weeks
Overall Survival (OS)
OS is defined as time from randomisation to death irrespective of the cause of the death.
Measured: From randomization until death or study discontinuation; Up to 213 weeks
Best Overall Response
Best overall response (BOR) is defined as the best response recorded at any time from the date of randomisation until the end of treatment.
Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.
Measured: time from the date of randomisation until study completion/discontinuation; Up to 213 weeks
Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria
Patients were to have a pre-treatment CA-125 of at least twice the upper limit of normal to be considered for CA-125 response. Patients were not evaluable by CA-125 if they had received mouse antibodies or if they had undergone medical and/or surgical interference with their peritoneum or pleura during the previous 28 days. In eligible patients, a CA-125 response was defined as the moment the CA- 25 was reduced by 50%, with this being confirmed with a consecutive CA-125 assessment not earlier than 28 days after the previous one.
Biological response rate based on serum CA-125 levels was assessed according to the guidelines by the Gynaecologic Cancer Intergroup. Monitoring of blood levels of the tumour marker CA-125 was performed at screening and every 6 weeks thereafter.
Measured: At screening and every 6 weeks thereafter (Up to 213 weeks)
Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria
Biological PFS including assessment of CA-125 levels was defined as the time from randomisation until the first occurrence of progressive disease according to CA-125, progressive disease according to radiological evidence, or death.
Also according to the below criterias,
- In patients with radiological measurable disease, disease progression during study treatment could not be declared on the basis of CA-125 alone.
- Patients with elevated CA-125 pre-treatment and normalization of CA-125 had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart or
- Patients with elevated CA-125 pre-treatment, which never normalized, had to show evidence of CA-125 ≥ to two times the nadir value on two occasions at least one week apart or
- Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart.
Measured: At screening and every 6 weeks thereafter (Up to 213 weeks )
Time to Deterioration in Global Health Status/Quality of Life (QOL)
Time to deterioration in global health status/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.
Measured: Every 6 weeks (Up to 213 weeks )
Time to Deterioration in Fatigue/Quality of Life (QOL)
Time to deterioration in fatigue/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.
Measured: Every 6 weeks (Up to 213 weeks )
Time to Deterioration in Pain/ Quality of Life (QOL)
Time to deterioration in pain/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.
Measured: Every 6 weeks (Up to 213 weeks )
Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL)
Time to deterioration in abdominal bloating/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.
Measured: Every 6 weeks (Up to 213 weeks )
Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL)
Three most troublesome disease specific symptoms, defined by the patient at baseline.
Patients that have defined more than 3 most troublesome symptoms have not been taken into account in the analysis.
Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.
The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.
Measured: Every 6 weeks (Up to 213 weeks)
Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Incidence and intensity of adverse events according to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: From first treatment administration to 21 days after the last drug administration (Up to 1403 days)
Clinically Relevant Changes in Laboratory and ECG Data
Clinically relevant changes in laboratory and ECG data
Measured: From first treatment administration to 21 days after the last drug administration (Up to 1403 days)
AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS
AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for BI 6727 BS
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS
AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for CD 10899 BS (metabolite of Volasertib BI 6727)
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS
AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for BI 6727 BS
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS
AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for CD 10899 BS (metabolite of Volasertib BI 6727)
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma
Cmax; maximum measured concentration of BI 6727 BS in plasma
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma
Cmax; maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma
tmax; time from dosing to maximum measured concentration of BI 6727 BS in plasma
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma
tmax; time from dosing to maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
t1/2; Terminal Half-life of BI 6727 BS in Plasma
t1/2; Terminal half-life of BI 6727 BS in plasma
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
t1/2; Terminal Half-life of CD 10899 BS in Plasma
t1/2; Terminal half-life of CD 10899 BS in plasma
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
MRT; Mean Residence Time of BI 6727 BS in the Body
MRT; Mean residence time of BI 6727 BS in the body
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration
CL; total clearance of BI 6727 BS in plasma after intravenous administration
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS
Vss;apparent volume of distribution at steady state following intravenous administration for BI 6727 BS
Measured: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Biomarkers and Pharmacogenetics Analysis (Optional)
This endpoint has not been statistically analysed in the study report
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121406
- Sponsor's protocol ID
- 1230.18
- Other IDs
- 2009-015770-35, 2009
- Status last verified
- Jul 2015
- First submitted
- 13 Apr 2010
- Last updated
- 13 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
PubMed 37407274Pujade-Lauraine E, Selle F, Weber B, Ray-Coquard IL, Vergote I, Sufliarsky J, Del Campo JM, Lortholary A, Lesoin A, Follana P, Freyer G, Pardo B, Vidal L, Tholander B, Gladieff L, Sassi M, Garin-Chesa P, Nazabadioko S, Marzin K, Pilz K, Joly F. Volasertib Versus Chemotherapy in Platinum-Resistant or -Refractory Ovarian Cancer: A Randomized Phase II Groupe des Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire Study. J Clin Oncol. 2016 Mar 1;34(7):706-13. doi: 10.1200/JCO.2015.62.1474. Epub 2016 Jan 11.
PubMed 26755507
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy
- ClinicalTrials.gov ID
- NCT01121406
- Acronym / sponsor ID
- 1230.18
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Posted 13 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer.
100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1.
Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727.
Others endpoints: biomarkers and pharmacogenetics analysis (optional)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 6727 | Experimental | Drug: BI 6727Patients receive BI 6727 infusion every 3 weeks |
| Cytotoxic | Active comparator | Drug: Paclitaxel, Drug: Gemcitabine, Drug: Topotecan, Drug: Pegylated liposomal doxorubicin (PLD)At the investigator discretion, patient will receive one of the following cytotoxics: topotecan, paclitaxel, gemcitabine or liposomal doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed recurrent epithelial ovarian carcinoma, peritoneal carcinoma or fallopian tube carcinoma.
- Platinum resistant or platinum refractory disease.
- Eastern Collaborative Oncology Group performance status < = 2.
- Life expectancy > = 3 months.
- At least one measurable lesion (Response Evaluation Criteria In Solid Tumours version 1.1).
Key exclusion criteria (8 listed)
- Contre-indications for cytotoxic treatment according to the Summary of Product Characteristics (Arm B).
- Clinical evidence of active brain metastasis or leptomeningeal involvement.
- Other malignancy currently requiring active therapy.
- QTc prolongation according to Fridericia formula deemed clinically relevant by the investigator (e.g., congenital long QT syndrome, QTc according to Fridericia formula > 470 ms).
- Hypersensitivity to one of the trial drugs or the excipients.
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 |
|---|---|---|
| PaclitaxelPatients receive paclitaxel in a 4 week schedule | Drug | Cytotoxic |
| GemcitabinePatients receive gemcitabine in a 3 week schedule | Drug | Cytotoxic |
| TopotecanPatients receive topotecan in 3 or 4 week schedule | Drug | Cytotoxic |
| Pegylated liposomal doxorubicin (PLD)Patients receive PLD in a 4 week schedule | Drug | Cytotoxic |
| BI 6727Patients receive BI 6727 infusion every 3 weeks | Drug | BI 6727 |
Primary outcome
Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1
Time frame: Week 24
DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).
26 secondary outcomes
Progression Free Survival (PFS)
Time frame: From randomization until disease progression, death or study discontinuation; Up to 213 weeks
Overall Survival (OS)
Time frame: From randomization until death or study discontinuation; Up to 213 weeks
Best Overall Response
Time frame: time from the date of randomisation until study completion/discontinuation; Up to 213 weeks
Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria
Time frame: At screening and every 6 weeks thereafter (Up to 213 weeks)
Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria
Time frame: At screening and every 6 weeks thereafter (Up to 213 weeks )
Time to Deterioration in Global Health Status/Quality of Life (QOL)
Time frame: Every 6 weeks (Up to 213 weeks )
Time to Deterioration in Fatigue/Quality of Life (QOL)
Time frame: Every 6 weeks (Up to 213 weeks )
Time to Deterioration in Pain/ Quality of Life (QOL)
Time frame: Every 6 weeks (Up to 213 weeks )
Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL)
Time frame: Every 6 weeks (Up to 213 weeks )
Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL)
Time frame: Every 6 weeks (Up to 213 weeks)
Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time frame: From first treatment administration to 21 days after the last drug administration (Up to 1403 days)
Clinically Relevant Changes in Laboratory and ECG Data
Time frame: From first treatment administration to 21 days after the last drug administration (Up to 1403 days)
AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
t1/2; Terminal Half-life of BI 6727 BS in Plasma
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
t1/2; Terminal Half-life of CD 10899 BS in Plasma
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
MRT; Mean Residence Time of BI 6727 BS in the Body
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS
Time frame: -0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration
Biomarkers and Pharmacogenetics Analysis (Optional)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37407274Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
- Derived from this study: PubMed 26755507Pujade-Lauraine E, Selle F, Weber B, Ray-Coquard IL, Vergote I, Sufliarsky J, Del Campo JM, Lortholary A, Lesoin A, Follana P, Freyer G, Pardo B, Vidal L, Tholander B, Gladieff L, Sassi M, Garin-Chesa P, Nazabadioko S, Marzin K, Pilz K, Joly F. Volasertib Versus Chemotherapy in Platinum-Resistant or -Refractory Ovarian Cancer: A Randomized Phase II Groupe des Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire Study. J Clin Oncol. 2016 Mar 1;34(7):706-13. doi: 10.1200/JCO.2015.62.1474. Epub 2016 Jan 11.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Gemcitabine and Topotecan in people with Ovarian Neoplasms, run by Boehringer Ingelheim at 31 sites in 5 countries.
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 7 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: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Spain, Belgium, Sweden, Slovakia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01121406, which also lists 2 linked publications.
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 13 Aug 2015.