Phase 2
Completed N=32
BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer
Ovarian Cancer · Fallopian tube cancer · Peritoneal Cancer
Source: ClinicalTrials.gov NCT01669798 ↗
Enrolled (actual)
32
Serious AEs
22.2%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Patients Who Survive Progression-free — 11.5 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Survive Progression-free |
11.5 | — |
| SECONDARY Objective Tumor Response Via RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 |
7.4 | — |
| SECONDARY Duration of Progression-Free Survival |
1.8; 16 | — |
| SECONDARY Objective Tumor Response Based on GCIG CA-125 Criteria |
— | — |
| SECONDARY Adverse Event Frequency and Severity |
2; 1; 1; 7; 3; 17 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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) 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01669798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.