Ovarian NeoplasmsPhase 2NCT00710762

A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer

A Phase 2 study testing BIBF1120 in people with Ovarian Neoplasms, run by Boehringer Ingelheim at 11 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to estimate the Progression Free Survival Rates (PFS) of patients with relapsed ovarian cancer after 9 months of continuous treatment with either BIBF 1120 or matching placebo. 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?: BIBF1120
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 11 sitesUnited Kingdom
Study dates: Mar 2006to Mar 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

Female patients with histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma or primary peritoneal cancer of serous type with recurrent disease and who responded to 2nd, 3rd or 4th line chemotherapy. Response is defined as either a confirmed decline in CA125 of at least 50% from the pre-treatment value or an Objective Response, i.e. a Partial Response (PR) or Complete Response (CR) according to the RECIST criteria in patients with measurable disease.
Treatment-free interval of < 12 months since commencing prior treatment regimen for relapsed ovarian cancer.
Full recovery from all therapy related toxicities of previous chemotherapy and or radiotherapy or recovery in as much as no further improvement may be expected by the investigator.
Age > 18 years.
Life expectancy of at least 3 months.
ECOG Performance Score < 2.

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Adequate hepatic function: total bilirubin 26µmol/L, ALT and/or AST 1.5x upper limit of normal (ULN). INR, Prothrombin time (PT) and partial thromboplastin time (PTT): maximum 50% deviation from normal limits.
Adequate renal function: serum creatinine 1.5 x ULN.
Absolute neutrophil count (ANC) >1.5 x 109l, Platelets > 100 x 109/l, Haemoglobin > 9.0 g/dl.
Written informed consent consistent with ICH-GCP guidelines.
Minimum time elapsed since last chemotherapy (including hormonal treatment other than Hormone Replacement Therapy [HRT]) or immunotherapy and the first administration of BIBF 1120 must be more than 4 but less than 8 weeks.

Who cannot join

Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
Major injuries and/or surgery within past 4 weeks with incomplete wound healing or bone fracture and planned surgical procedures during the study period.
Hypersensitivity to BIBF 1120 or the excipients of the study drug.
Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure > NYHA II).
History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
Patients who require full-dose anticoagulation.

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Gastrointestinal disorders or abnormalities that would inhibit absorption of the study drug.
Brain metastases or leptomeningeal disease.
Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial.
Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug.
Patients unable to comply with the protocol.
Active alcohol or drug abuse.
Other documented malignancy with the exception of non-melanomatous skin cancer within the past 5 years.
Patients who are not clinically sterile.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United Kingdom11 sites

1199.9.4413 Boehringer Ingelheim Investigational Site
Burton-on-Trent
1199.9.4412 Boehringer Ingelheim Investigational Site
Cambridge
1199.9.4407 Boehringer Ingelheim Investigational Site
Creigiau, Cardiff
1199.9.4410 St James's University Hospital
Leeds
1199.9.4401 Boehringer Ingelheim Investigational Site
London
1199.9.4404 Boehringer Ingelheim Investigational Site
London
1199.9.4409 Boehringer Ingelheim Investigational Site
London
1199.9.4411 Boehringer Ingelheim Investigational Site
London
1199.9.4406 Boehringer Ingelheim Investigational Site
Manchester
1199.9.4402 Boehringer Ingelheim Investigational Site
Northwood
1199.9.4405 Boehringer Ingelheim Investigational Site
Sutton

Other trials in United Kingdom

About this study

Conditions: Ovarian Neoplasms
Being tested: BIBF1120, Placebo
Medical subject headings: Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIBF1120Drug
PlaceboDrug

Study groups in NCT00710762
Study group	Role	What they receive
BIBF1120	Experimental	Not described Receives: Drug: BIBF1120
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

PFS Rate at 36 Weeks (After 9 Months)
The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.
Measured: 36 weeks (after 9 months)

Secondary outcomes (5)

PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)
The rate (probability) of being progression free at Week 12 and Week 24. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.
Measured: 12 weeks (after 3 months) and 24 weeks ( after 6 months)
Time to Tumour Progression
Time to Tumour Progression according to RECIST version 1.0 , CA-125 (ovarian tumour marker) levels and RECIST + CA-125 levels.
For CA-125, progressive disease was defined on the basis of progressive serial elevations of CA-125 according to the following criteria:
Patients with elevated CA-125 pre-treatment and normalisation of CA-125 had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. or Patients with elevated CA-125 pre-treatment that never normalised had to show evidence of CA-125 levels ≥2 x the nadir value on 2 occasions at least 1 week apart. or Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart.
Composite (RECIST+CA-125) endpoint is the RECIST progressive disease (PD) if it occurred or the CA-125 PD if it occurred in the absence of RECIST PD.
Measured: 9 months
Time to Death
This end point was not determined as no patients died during the trial.
Measured: 9 months
Incidence and Intensity of Adverse Events With Grading According CTCAE
Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).
Measured: First drug administration until 28 days after last drug administration,up until 309 days
Clinical Relevant Abnormalities for Laboratory Parameters
Clinical Relevant Abnormalities for laboratory parameters. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
Measured: First drug administration until 28 days after last drug administration, up until 309 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Mar 2014

First posted4 Jul 2008 (estimated)
Study startMar 2006
Primary completionSep 2008
Study completionMar 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 (1)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: Prevention
Intervention model: Parallel groups
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00710762
Sponsor's protocol ID: 1199.9
Other IDs: EUDRACT2005-002427-14
Status last verified: Jul 2016
First submitted: 3 Jul 2008
Last updated: 15 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ovarian Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer
ClinicalTrials.gov ID: NCT00710762
Acronym / sponsor ID: 1199.9
Conditions: Ovarian Neoplasms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Sep 2008 (actual)
Study completion: Mar 2014 (actual)
First posted: 4 Jul 2008 (estimated)
Results: Posted 4 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Intervention model: Parallel groups
Number of arms: 2

Arm	Type	Receives
BIBF1120	Experimental	Drug: BIBF1120
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Female patients with histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma or primary peritoneal cancer of serous type with recurrent disease and who responded to 2nd, 3rd or 4th line chemotherapy. Response is defined as either a confirmed decline in CA125 of at least 50% from the pre-treatment value or an Objective Response, i.e. a Partial Response (PR) or Complete Response (CR) according to the RECIST criteria in patients with measurable disease.
Treatment-free interval of < 12 months since commencing prior treatment regimen for relapsed ovarian cancer.
Full recovery from all therapy related toxicities of previous chemotherapy and or radiotherapy or recovery in as much as no further improvement may be expected by the investigator.
Age > 18 years.
Life expectancy of at least 3 months.

Key exclusion criteria (14 listed)

Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
Major injuries and/or surgery within past 4 weeks with incomplete wound healing or bone fracture and planned surgical procedures during the study period.
Hypersensitivity to BIBF 1120 or the excipients of the study drug.
Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure > NYHA II).
History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.

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
BIBF1120	Drug	BIBF1120
Placebo	Drug	Placebo

Primary outcome

PFS Rate at 36 Weeks (After 9 Months)
Time frame: 36 weeks (after 9 months)
The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.

5 secondary outcomes

PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)
Time frame: 12 weeks (after 3 months) and 24 weeks ( after 6 months)
Time to Tumour Progression
Time frame: 9 months
Time to Death
Time frame: 9 months
Incidence and Intensity of Adverse Events With Grading According CTCAE
Time frame: First drug administration until 28 days after last drug administration,up until 309 days
Clinical Relevant Abnormalities for Laboratory Parameters
Time frame: First drug administration until 28 days after last drug administration, up until 309 days

Results and safety

Results posted to the registry on 4 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nintedanib	44	5
Placebo	40	0

Primary outcome: PFS Rate at 36 Weeks (After 9 Months)

Time frame: 36 weeks (after 9 months). Number (95% Confidence Interval). Unit: percent probability of PFS

Measure	Nintedanib n = 43	Placebo n = 40
Value	15.6 (3.8 to 27.3)	2.9 (0.0 to 8.4)

Population analysed: Treated set.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: First drug administration until 28 days after last drug administration, up until 309 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nintedanib	14 of 43 (32.6%)	42 of 43 (97.7%)	Not reported
Placebo	10 of 40 (25%)	37 of 40 (92.5%)	Not reported

Limitations and caveats (from the sponsor): Data from all randomised patients collected upto NOV'08 were included in all above sections,unless stated otherwise.5 patients continued on BIBF1120 after database lock(DBL)-NOV'08 upto Mar'14,but due to limited data no further analyses were done.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Related trials for Ovarian Neoplasms

RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
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A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
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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

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBF1120 in people with Ovarian Neoplasms, run by Boehringer Ingelheim at 11 sites in United Kingdom.

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 11 inclusion and 14 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 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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 4 Dec 2014). 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?

PFS Rate at 36 Weeks (After 9 Months) (time frame: 36 weeks (after 9 months)). 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 NCT00710762, which also lists 1 linked publication.

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 15 Aug 2016.