Trial record 1 of 1 for:    GOG-0229K
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Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225887
Recruitment Status : Completed
First Posted : October 21, 2010
Results First Posted : October 9, 2017
Last Update Posted : October 9, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Brief Summary:
This phase II trial studies the side effects and how well nintedanib works in treating patients with endometrial cancer that has come back. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

Condition or disease Intervention/treatment Phase
Endometrial Adenocarcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Mucinous Adenocarcinoma Endometrial Serous Adenocarcinoma Endometrial Squamous Cell Carcinoma Endometrial Transitional Cell Carcinoma Endometrial Undifferentiated Carcinoma Malignant Uterine Corpus Mixed Epithelial and Mesenchymal Neoplasm Recurrent Uterine Corpus Carcinoma Drug: Nintedanib Phase 2

Detailed Description:


I. To estimate the proportion of patients with persistent or recurrent endometrial cancer, who survive progression-free without going on a subsequent therapy against the disease for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with BIBF 1120 (nintedanib).

II. To determine the nature and degree of toxicity of BIBF 1120 in this cohort of patients.


I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with BIBF 1120.


Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of BIBF 1120 in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Start Date : October 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Experimental: Treatment (nintedanib)
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Nintedanib
Given PO
Other Names:
  • BIBF 1120
  • BIBF-1120
  • Intedanib
  • Multitargeted Tyrosine Kinase Inhibitor BIBF 1120
  • tyrosine kinase inhibitor BIBF 1120
  • Vargatef

Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Up to 5 years ]
    The incidence of adverse events (grade 3 or higher) as assessed by the National Cancer Institute CTCAE version 4.0

  2. Objective Tumor Response [ Time Frame: For disease that can be evaluated by physical exam,response was assessed prior to each cycle CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years. ]
    Complete and Partial Tumor Response by RECIST 1.1

  3. Progression-free Survival > 6 Months [ Time Frame: for disease that can be evaluated by physical exam, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years. ]
    Whether or not the patient survived progression-free for at least 6 months.

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years ]
    The observed length of life from entry into the study to death or the date of last contact.

  2. Progression Free Survival [ Time Frame: The duration of time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years ]
    the period of progression free survival for patients with persistent or recurrent endometrial cancer treated with study drug.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (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
  • Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population
  • Patients must have a GOG performance status of 0, 1, or 2
  • Patients must have normal thyroid function; patients with a history of hypothyroidism are eligible, provided it is well controlled on medication
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection)
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
  • Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration
  • Any prior radiation therapy must be completed at least 4 weeks prior to registration
  • Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer will be counted as a systemic chemotherapy regimen
  • Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
  • Patients must have NOT received any non-cytotoxic (biologic or targeted) agents, as part of their primary treatment or for management of recurrent or persistent disease; non-cytotoxic (biologic or targeted) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction; prior hormonal therapy is allowed; there is no limit on the number of prior hormonal therapies allowed
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
  • Urine protein creatinine (UPC) ratio must be < 1.0 gm; if UPC ratio >= 1, collection of 24-hour urine measurement of urine protein is recommended
  • Bilirubin must be less than 1.5 X ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be less than 3 X ULN
  • Alkaline phosphatase must be less than 2.5 X ULN
  • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) =< 1.5 times the institutional upper limit of normal
  • Electrocardiogram (EKG) must have corrected QT interval (QTc) < 450 msec without evidence of serious ventricular arrhythmia (ventricular tachycardia lasting more than 3 beats or ventricular fibrillation)
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must meet pre-entry requirements
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry; women of child-bearing potential must agree to use adequate contraception (two barrier methods of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she is to inform her treating physician immediately; all patients must be willing to take contraception up to three months after the final dose of BIBF 1120

Exclusion Criteria:

  • Patients who have had prior therapy with BIBF 1120
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients with serious, non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to the start date of treatment; patients with underlying lesions that caused the fistula or perforation in the past that have not been corrected
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients with history of brain metastases, or evidence upon physical examination of active central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy or any brain metastases
  • Uncontrolled hypertension, defined as systolic >= 150 mm Hg or diastolic >= 90 mm Hg
  • Myocardial infarction or unstable angina within 6 months of study treatment
  • New York Heart Association (NYHA) class II or greater congestive heart failure
  • Women with an ejection fraction < institutional lower limit of normal (LLN)
  • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)
  • Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater peripheral vascular disease
  • History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of study treatment
  • Patients undergoing invasive procedures as defined below: major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of treatment; major surgical procedure anticipated during the course of the study; minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of therapy
  • Patients who are pregnant or nursing
  • Patients with a history of major thromboembolic event defined as: symptomatic pulmonary embolism (PE), recurrent asymptomatic PE, or recurrent deep venous thrombosis
  • Prior thrombosis or thromboembolic event due to a known inherited coagulopathy (i.e., antithrombin-III deficiency, protein C or protein S deficiency, factor V Leiden mutation presence, prothrombin G20210A mutation)
  • Serious infections requiring systemic antibiotics or antiviral therapy including: known active hepatitis B or C infection; known human immunodeficiency virus (HIV) infection
  • Gastrointestinal (GI) or other medical disorders that would impact ingestion or absorption of the drug
  • Patients with a history of photosensitivity or who must take agents which increase photosensitivity, e.g. topical retinoids and doxycycline
  • Patients who are unable to swallow capsules

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01225887

  Hide Study Locations
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
United States, Georgia
Memorial University Medical Center
Savannah, Georgia, United States, 31404
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
United States, Indiana
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, United States, 21237
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States, 48106
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Allegiance Health
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Carolinas HealthCare System NorthEast
Concord, North Carolina, United States, 28025
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
United States, Washington
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Northwest Hospital
Seattle, Washington, United States, 98133
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Don Dizon NRG Oncology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gynecologic Oncology Group Identifier: NCT01225887     History of Changes
Other Study ID Numbers: GOG-0229K
NCI-2011-02657 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0229K ( Other Identifier: NRG Oncology )
GOG-0229K ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: October 21, 2010    Key Record Dates
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017
Last Verified: October 2016

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma, Transitional Cell
Cystadenocarcinoma, Serous
Adenocarcinoma, Mucinous
Uterine Neoplasms
Adenocarcinoma, Clear Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action