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Ovarian CancerPhase 2NCT01669798

BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer

A Phase 2 study testing BIBF 1120 in people with Ovarian Cancer and Fallopian Tube Cancer, run by AA Secord at 3 sites in United States.

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 main purpose of this study is to see if BIBF 1120 can increase the number of women with bevacizumab resistant, persistent, or recurrent epithelial ovarian cancer who do not progress for at least six months. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
BIBF 1120
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
3 sitesUnited States
Study dates
Feb 2013to Feb 2018
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

  • Recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma w/ histologic documentation of the original primary tumor via the pathology report:
  • serious, endometrioid, mucinous, or clear cell adenocarcinoma
  • undifferentiated, mixed epithelial or transitional cell carcinoma
  • Brenner's Tumor
  • adenocarcinoma NOS
  • Had treatment-free interval following response to bevacizumab (CR, PR, or SD) of < 6 months, or have progressed during treatment w/ a bevacizumab-containing therapy
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  • Measurable or detectable disease. Measurable is defined by RECIST 1.1. Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI. Detectable defined as no measurable disease but either ascities/pleural effusion or solid/cystic abnormalities that don't meet RECIST 1.1 - both within the setting of CA125 >2xULN
  • Those with measurable disease must have at least one "target lesion" to assess response as defined by RECIST 1.1. Tumors in a previously irradiated field will be designated as "non-target" lesions
  • Must have a ECOG Performance Status of 0 or 1
  • Free of active infection requiring antibiotics. Exception: uncomplicated UTI
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy
  • Hormonal therapy directed at the malignant tumor must be d/c at least a week prior to registration. Hormone replacement therapy is permitted
  • Other prior therapy directed at malignant tumor, including immunologic agents, must be d/c at least 3 weeks prior to registration; 4 weeks if prior therapy was w/ bevacizumab
  • Prior therapy
  • must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
  • Allowed, to receive, but not required to receive, 2 additional cytotoxic regimens for management of recurrent or persistent disease according to the following:
  • Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy.
  • Patients must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease other than bevacizumab. Patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy as part of their primary treatment regimen.
  • Must have adequate:
  • Bone marrow function: Absolute neutrophil count (ANC) ≥ 1,500/mcl, equivalent to (CTCAE v4.0) grade 1. Platelets ≥ 100,000/mcl. Hemoglobin (Hb) ≥ 9.0 g/dL
  • Renal function: creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Hepatic function: Bilirubin should be w/in normal limits (CTCAE v4.0, grade 1). ALT/AST, should be ≤ 1.5 x ULN (CTCAE v4.0, grade 1). For patients w/ liver metastases, ALT/AST should be ≤ 2.5 x ULN; Alkaline phosphatase should be ≤ 2.5 x ULN (CTCAE v4.0, grade 1)
  • Neurologic function: Neuropathy ≤ CTCAE v4.0, grade 1
  • Blood coagulation parameters: PT w/ international normalized ratio (INR) < 1.5 x ULN \& a PTT < 1.5 x ULN (or an in-range PTT if on a stable dose of therapeutic heparin). Low molecular weight heparin (enoxaparin or alternative anticoagulants (other than warfarin)) are acceptable.
  • Signed informed consent \& authorization permitting release of personal health information
  • Negative serum pregnancy test if of childbearing potential prior to study entry \& use of effective form of contraception until 3 months after receiving last drug treatment
  • Patients may have undergone a major or minor surgical procedure as long as:
  • > 28 days prior to the first date of study therapy
  • Core biopsy or IV Port placement greater than 7 days prior to the first date of study therapy

Who cannot join

  • Previous treatment w/ BIBF 1120.
  • Pregnant or breastfeeding.
  • Received radiation to more than 25% of marrow-bearing areas
  • History of other invasive malignancies, w/ the exception of non-melanoma skin cancer, if there is any evidence of other malignancy being present w/in the last five years.
  • Received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for treatment of ovarian, fallopian tube, or primary peritoneal cancer w/in the last 5 years.
  • Prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer or localized breast cancer w/in the last 5 years.
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  • A history of abdominal or tracheal-esophageal fistula, or gastrointestinal perforation
  • A history of intra-abdominal abcess w/in 6 months of enrollment
  • Serious, uncontrolled, concomitant disorder(s) such as diabetes mellitus
  • Patients w/ clinically significant cardiovascular disease including: uncontrolled hypertension: systolic > 150 mm Hg/diastolic > 90 mm Hg; unstable angina or who have had a myocardial infarction w/in the past six months prior to registration; congestive heart failure; cardiac arrhythmia requiring medication (doesn't include asymptomatic atrial fibrillation); grade 2 or greater peripheral vascular disease (at least brief (<24 hours) episodes of ischemia managed non-surgically \& w/o permanent deficit.
  • Serious non-healing wound, ulcer, or bone factor.
  • o Granulating incisions healing by secondary intention w/ no evidence of fascial dehiscence or infection ARE eligible but require weekly wound examinations.
  • Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
  • History/evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled w/ standard medical therapy, any brain metastases, CVA, TIA, or subarachnoid hemorrhage w/in 6 months of the first date of treatment on this study.
  • Central pulmonary metastases/recent hemoptysis (≥1/2 tsp of red blood) w/in 28 days of registration.
  • Clinically significant proteinuria (i.e. >Grade 1) or UPC ratio above 1.0
  • Suspicion of transmural tumor bowel involvement based on the investigator's discretion.
  • Clinical symptoms/signs of gastrointestinal obstruction \& require IV hydration \&/or nutrition.
  • Patients taking warfarin are not eligible

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

Other trials in United States

About this study

Official title: Phase II Evaluation of BIBF 1120 in the Treatment of Bevacizumab-Resistant, Persistent, or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

The main purpose of this study is to see if BIBF 1120 can increase the number of women with bevacizumab resistant, persistent, or recurrent epithelial ovarian cancer who do not progress for at least six months.

Read the detailed description

Ovarian cancer patients with platinum-resistant and refractory disease have the lowest response rates to relapse chemotherapy: various chemotherapeutic agents, such as paclitaxel, liposomal doxorubicin, topotecan, docetaxel, platinum, etoposide, ifosfamide, gemcitabine, and vinorelbine are available but result in response rates of 7-40%. Unfortunately, relapse therapy is not curative and treatment is only palliative. Recently two phase II trials demonstrated that anti-angiogenic therapy with bevacizumab alone or in combination with chemotherapy in women with recurrent disease had response rates ranging from 16-24% with an acceptable toxicity profile. However, resistance can develop to VEGF inhibition. Therefore other novel anti-angiogenic agents, such as BIBF 1120, should be evaluated in the treatment of ovarian cancer.

Being tested
BIBF 1120
Keywords
Recurrent epithelial ovarian carcinoma, Persistent epithelial ovarian carcinoma, Bevacizumab resistant epithelial ovarian carcinoma
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • BIBF 1120Drug

    Also called Vargatef™, Nintedanib

    PO 200mg BID

Study groups in NCT01669798
Study groupRoleWhat they receive
BIBF 1120ExperimentalBIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.
Receives: Drug: BIBF 1120

What is being measured

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

  1. Percentage of Patients Who Survive Progression-free

    Measure of Progression Free Survival (PFS) by the percentage of patients who survive progression-free for at least 6 months after initiating study therapy in patients with bevacizumab-resistant, persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

    Measured: 6 months

Secondary outcomes (4)

  1. Objective Tumor Response Via RECIST (Response Evaluation Criteria in Solid Tumors) 1.1

    Evaluating the percentage of patients who have objective tumor response (complete or partial) based on RECIST 1.1 criteria.

    Measured: 1 year

  2. Duration of Progression-Free Survival

    The duration of progression-free survival and overall survival measured in months; Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.

    Measured: Through study completion, on average 2 years

  3. Objective Tumor Response Based on GCIG CA-125 Criteria

    The proportion of patients who have objective tumor response (complete or partial) based on Gynaecologic Cancer InterGroup(GCIG) CA-125 criteria which is: "A response according to CA 125 has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days.".

    Measured: 1 year

  4. Adverse Event Frequency and Severity

    To determine frequency and severity of adverse events as assessed using NCI Common Toxicity Criteria version 4.

    Measured: 1 year

Timeline

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

  1. First posted21 Aug 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completion10 Sep 2017
  4. Study completionFeb 2018

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01669798
Sponsor's protocol ID
Pro00033060
Status last verified
Oct 2018
First submitted
10 Jul 2012
Last updated
16 Oct 2018
Data monitoring committee
No
FDA-regulated drug
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIBF 1120 in people with Ovarian Cancer and Fallopian Tube Cancer, run by AA Secord at 3 sites in United States.

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 29 inclusion and 19 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 16 Oct 2018). 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?

Percentage of Patients Who Survive Progression-free (time frame: 6 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 NCT01669798.

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 16 Oct 2018.

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