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

NCT01669798 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00033060
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

Recurrent epithelial ovarian carcinoma; Persistent epithelial ovarian carcinoma; Bevacizumab resistant epithelial ovarian carcinoma

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (4)

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

  1 year

• Duration of Progression-Free Survival

  Through study completion, on average 2 years

• Objective Tumor Response Based on GCIG CA-125 Criteria

  1 year

• Adverse Event Frequency and Severity

  1 year

Other Outcomes (5)

• Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response

  1 year

• Coagulation and Endothelial Cell Activation Markers

  1 year

• VEGF Levels Correlated With Treatment Outcome

  1 year

Study Arms (1)

BIBF 1120

EXPERIMENTAL

BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.

Drug: BIBF 1120

Interventions

BIBF 1120 DRUG

PO 200mg BID

Also known as: Vargatef™, Nintedanib

BIBF 1120

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AA Secord: lead
• Boehringer Ingelheim: collaborator

Study Sites (3)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Angeles Alvarez Secord
• Organization: Duke University Medical Center

secor002@mc.duke.edu

919-684-3765

Study Officials

• Angeles A Secord, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: August 21, 2012
• Study Start: February 1, 2013
• Primary Completion: September 10, 2017
• Study Completion: February 1, 2018
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2018-10

Locations

US (3)