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A Phase II Evaluation of BIBF 1120 (IND #) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Phase 2
18 Years
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

A Phase II Evaluation of BIBF 1120 (IND #) in the Treatment of Recurrent or Persistent Endometrial Carcinoma



- 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

- To assess objective tumor response (complete or partial) in patients with recurrent or
persistent endometrial carcinoma treated with BIBF 1120.

- To determine the nature and degree of toxicity of BIBI 1120 in these patients.


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

OUTLINE: This is a multicenter study.

Patients receive oral BIBF 1120 twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

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

Inclusion Criteria


- Histologically confirmed endometrial carcinoma (original primary tumor)

- Recurrent or persistent disease that is refractory to curative therapy or
established treatments

- Patients with the following histologic epithelial cell types allowed:

- Endometrioid adenocarcinoma

- Serous adenocarcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Mixed epithelial carcinoma

- Adenocarcinoma not otherwise specified (N.O.S.)

- Mucinous adenocarcinoma

- Squamous cell carcinoma

- Transitional cell carcinoma

- Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1
dimension (longest to be recorded) as ≥ 10 mm by CT scan, MRI, or caliper measurement
by clinical exam OR ≥ 20 mm by chest x-ray

- Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI

- Must have ≥ 1 "target lesion" to assess response on this protocol as defined by

- 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 ≥ 90 days following completion of radiotherapy

- Patients must not be eligible for a higher-priority GOG protocol, if one exists
(e.g., any active GOG phase III protocol or rare tumor protocol for the same patient

- Must have had 1 prior chemotherapy regimen for the management of endometrial

- Chemotherapy in conjunction with primary radiation as a radio-sensitizer is
counted as a systemic chemotherapy regimen

- No history or evidence of brain metastases or active CNS disease upon physical
examination, including brain tumor


- GOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Urine protein creatinine (UPC) ratio < 1.0 g

- Bilirubin ≤ 1.5 times ULN

- AST and ALT ≤ 3.0 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- INR ≤ 1.5 times ULN OR an in-range INR, usually between 2 and 3, if the patient is on
a stable dose of therapeutic warfarin

- PTT ≤ 1.5 times ULN

- Normal thyroid function

- History of hypothyroidism allowed provided it is well controlled with medication

- EKG must have QTc < 450 msec without evidence of serious ventricular arrhythmia
(ventricular tachycardia lasting more than 3 beats or ventricular fibrillation)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must agree to use effective contraception (two barrier methods of
birth control) prior to, during, and for 3 months after final dose of BIBF 1120

- No other invasive malignancies except non-melanoma skin cancer or curatively treated
localized cancer of the breast, head and neck, or skin with no evidence of recurrent
or metastatic disease for more than 3 years

- No serious, non-healing wound, ulcer, or bone fracture, including the following:

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the past 28 days

- Underlying lesions that caused the fistula or perforation in the past that have
not been corrected

- No active bleeding or pathologic conditions that carry high-risk of bleeding, such as
known bleeding disorder, coagulopathy, or tumor involving major vessels

- No seizures not controlled with standard medical therapy

- No clinically significant cardiovascular disease including, but not limited to, any
of the following:

- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg
or diastolic BP > 90 mm Hg

- Myocardial infarction or unstable angina within the past 6 months

- NYHA class II-IV congestive heart failure

- Women with an ejection fraction < normal

- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or
ventricular fibrillation), or cardiac arrhythmias requiring anti-arrhythmic
medications except atrial fibrillation that is well controlled with
anti-arrhythmic medication

- Peripheral vascular disease ≥ grade 2 by NCI CTCAE

- History of cerebrovascular accident (CVA or stroke), transient ischemic attack
(TIA), or subarachnoid hemorrhage within the past 6 months

- No history of major thromboembolic event defined as symptomatic pulmonary embolism
(PE), recurrent asymptomatic PE, or recurrent deep venous thrombosis

- No 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, or prothrombin G20210A mutation)

- No serious infections (except uncomplicated urinary tract infection) requiring
systemic antibiotics or antiviral therapy, including known active hepatitis B or C
infection, or HIV infection

- No gastrointestinal or other medical disorder that would impact ingestion or
absorption of the study drug

- Patient must be able to swallow capsules

- No history of photosensitivity

- No significant traumatic injury within the past 28 days


- See Disease Characteristics

- Recovered from recent surgery, radiotherapy, or chemotherapy

- At least 1 week since prior hormonal therapy directed at the malignant tumor

- At least 3 weeks since prior therapy directed to the malignant tumor, including
chemotherapy and immunologic agents

- One prior cytotoxic regimen for management of recurrent or persistent disease allowed

- 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

- Prior hormonal therapy is allowed

- There is no limit on the number of prior hormonal therapies allowed

- No prior BIBF 1120

- No prior cancer treatment that contraindicates this protocol therapy

- No prior radiotherapy to any portion of the abdominal cavity or pelvis other than for
the treatment of endometrial cancer within the past 3 years

- Any prior radiation therapy must be completed at least 4 weeks prior to

- More than 3 years since prior radiotherapy for localized cancer of the breast,
head and neck, or skin allowed provided patient remains free of recurrence or
metastatic disease

- No prior chemotherapy for any abdominal cavity or pelvis other than for the treatment
of endometrial cancer within the past 3 years

- More than 3 years since prior adjuvant chemotherapy for localized breast cancer
allowed provided patient remains free of recurrence or metastatic disease

- No prior major surgical procedure or open biopsy within the past 28 days

- No anticipation of these procedures during the course of the study

- No minor surgical procedures, fine-needle aspirates, or core biopsies within the past
7 days

- No agents that increase photosensitivity (e.g., topical retinoids and doxycycline) 1
week before, during, and 2 weeks after administration of BIBF 1120

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival for at least 6 months

Safety Issue:


Principal Investigator

Don S. Dizon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Women and Infants Hospital of Rhode Island


United States: Federal Government

Study ID:




Start Date:

October 2011

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial clear cell carcinoma
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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