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Brivanib Alaninate in Treating Patients With Recurrent or Persistent Endometrial Cancer
Phase 2 trial testing Brivanib Alaninate in Endometrial Adenocarcinoma in 45 participants. Completed in 16 July 2016.
| Lead sponsor | Gynecologic Oncology Group |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 6 July 2009 |
| Primary completion | 16 July 2016 |
| Estimated completion | 16 July 2016 |
| Sites | 35 locations across United States |
Gynecologic Oncology Group — full company profile →
18 and older, female only, with Endometrial Adenocarcinoma or Endometrial Clear Cell Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Whether or not the patient survived progression-free for at least 6 months.
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 30.2 | 19 – 44 |
Per response evaluation criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30 % decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 18.6 | 9 – 31 |
Characterized graphically with Kaplan-Meier estimates and using descriptive statistics. The effect of cell type (type I versus type II endometrial cancers) on overall survival will be examined.
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 10.7 | 9.2 – 18.1 |
Characterized graphically with Kaplan-Meier estimates and using descriptive statistics. The effect of cell type (type I versus type II endometrial cancers) on progression-free survival will be examined.
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 3.3 | 2.0 – 3.8 |
Adverse Events (grade 3 or higher)
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 9 |
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 12 |
| Group | Value | 95% CI |
|---|---|---|
| Brivanib | 1 |
Time frame: All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Brivanib |
|---|---|---|
| Hypertension | Cardiac disorders | — |
| Obstruction, Gi - Small Bowel Nos | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Thrombosis/Thrombus/Embolism | Vascular disorders | — |
| Inr | Vascular disorders | — |
| Death No Ctcae Term - Disease Progression Nos | General disorders | — |
| Death No Ctcae Term - Multi-Organ Failure | General disorders | — |
| Fistula, Gi - Rectum | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Musculoskeletal/St: Other | Musculoskeletal and connective tissue disorders | — |
| Muscle Weakness - Whole Body/Generalized | Musculoskeletal and connective tissue disorders | — |
| Mental Status | Nervous system disorders | — |
| Somnolence | Nervous system disorders | — |
| Pain: Tumor | General disorders | — |
| Obstruction, Gu - Bladder | Renal and urinary disorders | — |
| Reaction | System | Brivanib |
|---|---|---|
| Fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Ast | Metabolism and nutrition disorders | — |
| Alt | Metabolism and nutrition disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Pain: Head/Headache | General disorders | — |
| Leukocytes | Blood and lymphatic system disorders | — |
| Alkaline Phosphatase | Metabolism and nutrition disorders | — |
| Neuropathy-Sensory | Nervous system disorders | — |
| Hypertension | Cardiac disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Pain: Abdominal Pain Nos | General disorders | — |
| Platelets | Blood and lymphatic system disorders | — |
| Mucositis (Functional/Sympt) - Oral Cavity | Gastrointestinal disorders | — |
| Creatinine | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Pain: Back | General disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Pain: Extremity-Limb | General disorders | — |
| Weight Loss | General disorders | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Pain: Joint | General disorders | — |
| Inr | Vascular disorders | — |
| Hair Loss/Alopecia (Scalp Or Body) | Skin and subcutaneous tissue disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Proteinuria | Metabolism and nutrition disorders | — |
| Neutrophils | Blood and lymphatic system disorders | — |
| Nail Changes | Skin and subcutaneous tissue disorders | — |
| Mucositis (Clinical Exam) - Oral Cavity | Gastrointestinal disorders | — |
Most-reported serious reactions: Hypertension, Obstruction, Gi - Small Bowel Nos, Diarrhea, Hyperkalemia, Thrombosis/Thrombus/Embolism, Inr, Death No Ctcae Term - Disease Progression Nos, Death No Ctcae Term - Multi-Organ Failure.
Data from ClinicalTrials.gov NCT00888173 adverse events section.
This phase II trial is studying how well brivanib alaninate works in treating patients with endometrial cancer that has come back (recurred) or is persistent. Brivanib alaninate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing