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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
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This study will investigate the efficacy as well as the safety of RAD001 in combination with bevacizumab for recurrent ovarian, peritoneal, and fallopian tube cancer. RAD001 will be taken orally once daily and bevacizumab will be administered once every 14 days. The study will be conducted over a period of about 3 to 4 years.
In this trial, approximately 50 patients will receive the study drug, RAD001 in combination with bevacizumab (Avastin)chemotherapy. RAD001 will be taken orally once daily and bevacizumab will be administered intravenously once every 14 days. In addition to study treatment, a few blood samples and a sample of the patients tumor from a previous surgery if available will be collected for research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rad001/Bevacizumab | Other | Patients will receive RAD001 by mouth everyday and Bevacizumab IV every 14 days until clinical progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug | RAD001 10mg is taken orally (by mouth) once daily on a continuous basis. RAD001 is provided in tablet form and should be taken with a big glass of water on an empty stomach or after a low-fat meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) at 6-months | The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). | Up to 36 months (data collection period for the cohort); Up to 6 months for participant |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease) | The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). | Within 4 weeks (28 days) of study treatment initiation (baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Edwards, MD | University of Pittsburgh, Magee-Womens Hospital, Gynecologic Oncology Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RAD001 + Bevacizumab | Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RAD001 + Bevacizumab | Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) at 6-months | The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). | Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 36 months (data collection period for the cohort); Up to 6 months for participant |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RAD001 + Bevacizumab | Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac General - Other (Specify, __) | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rita Johnson, Associate Director of Clinical Research Services | UPMC Cancer Centers | 412-647-8571 | johnsonr1@upmc.edu |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D012008 | Recurrence |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061067 |
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|
| bevacizumab | Drug | bevacizumab will be administered intravenously (IV) once every 14 days. |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease) | The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). | Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days + imaging every 8-12 weeks | Posted | Number | participants | Within 4 weeks (28 days) of study treatment initiation (baseline) |
|
|
|
| 19 |
| 50 |
| 50 |
| 50 |
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Pericardial effusion (non-malignant) | Cardiac disorders | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Distension/bloating, abdominal | Gastrointestinal disorders | Systematic Assessment |
|
| Fistula, GI, Colon/cecum/appendix | Gastrointestinal disorders | Systematic Assessment |
|
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | Systematic Assessment |
|
| Mucositis/stomatitis (clinical exam), Oral cavity | Gastrointestinal disorders | Systematic Assessment |
|
| Obstruction, GI, Ileum | Gastrointestinal disorders | Systematic Assessment |
|
| Obstruction, GI, Small bowel NOS | Gastrointestinal disorders | Systematic Assessment |
|
| Hemorrhage, GU, Bladder | Renal and urinary disorders | Systematic Assessment |
|
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | Systematic Assessment |
|
| Infection with unknown ANC, Lung (pneumonia) | Infections and infestations | Systematic Assessment |
|
| Infection with unknown ANC, Urinary tract NOS | Infections and infestations | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy), Left-sided | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neurology - Other (Specify, __) | Nervous system disorders | Systematic Assessment |
|
| Speech impairment (e.g., dysphasia or aphasia) | Nervous system disorders | Systematic Assessment |
|
| Pain, Abdomen NOS | General disorders | Systematic Assessment |
|
| Pain, Rectum | General disorders | Systematic Assessment |
|
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary/Upper Respiratory - Other (Specify, __) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | Systematic Assessment |
|
| Blood/Bone Marrow - Other (Specify, __) | Blood and lymphatic system disorders |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders |
|
| Lymphopenia | Blood and lymphatic system disorders |
|
| Platelets | Blood and lymphatic system disorders |
|
| Hemoglobin | Blood and lymphatic system disorders |
|
| Supraventricular and nodal arrhythmia, Atrial fibrillation | Cardiac disorders |
|
| Supraventricular and nodal arrhythmia, Sinus bradycardia | Cardiac disorders |
|
| Cardiac Arrhythmia - Other (Specify, __) | Cardiac disorders |
|
| Palpitations | Cardiac disorders |
|
| Supraventricular and nodal arrhythmia, Sinus tachycardia | Cardiac disorders |
|
| Hypertension | Cardiac disorders |
|
| Rigors/chills | General disorders |
|
| Sweating (diaphoresis) | General disorders |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders |
|
| Insomnia | General disorders |
|
| Constitutional Symptoms - Other (Specify, __) | General disorders |
|
| Weight loss | General disorders |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders |
|
| Nail changes | Skin and subcutaneous tissue disorders |
|
| Rash: dermatitis associated with radiation, Chemoradiation | Skin and subcutaneous tissue disorders |
|
| Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | Skin and subcutaneous tissue disorders |
|
| Urticaria (hives, welts, wheals) | Skin and subcutaneous tissue disorders |
|
| Wound complication, non-infectious | Skin and subcutaneous tissue disorders |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders |
|
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders |
|
| Dry skin | Skin and subcutaneous tissue disorders |
|
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders |
|
| Dermatology/Skin - Other (Specify, __) | Skin and subcutaneous tissue disorders |
|
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders |
|
| Esophagitis | Gastrointestinal disorders |
|
| Fistula, GI, Colon/cecum/appendix | Gastrointestinal disorders |
|
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders |
|
| Mucositis/stomatitis (clinical exam), Larynx | Gastrointestinal disorders |
|
| Proctitis | Gastrointestinal disorders |
|
| Ascites (non-malignant) | Gastrointestinal disorders |
|
| Hemorrhoids | Gastrointestinal disorders |
|
| Mucositis/stomatitis (clinical exam), Anus | Gastrointestinal disorders |
|
| Mucositis/stomatitis (clinical exam), Rectum | Gastrointestinal disorders |
|
| Taste alteration (dysgeusia) | Gastrointestinal disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Heartburn/dyspepsia | Gastrointestinal disorders |
|
| Dehydration | Gastrointestinal disorders |
|
| Mucositis/stomatitis (functional/symptomatic), Oral cavity | Gastrointestinal disorders |
|
| Distension/bloating, abdominal | Gastrointestinal disorders |
|
| Gastrointestinal - Other (Specify, __) | Gastrointestinal disorders |
|
| Dental: teeth | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Anorexia | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Mucositis/stomatitis (clinical exam), Oral cavity | Gastrointestinal disorders |
|
| Hematoma | Vascular disorders |
|
| Hemorrhage, GI, Anus | Vascular disorders |
|
| Hemorrhage/Bleeding - Other (Specify, __) | Vascular disorders |
|
| Hemorrhage, pulmonary/upper respiratory, Nose | Vascular disorders |
|
| Infection - Other (Specify, __) | Infections and infestations |
|
| Infection (documented) Urinary tract NOS | Infections and infestations |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils, Bladder (urinary) | Infections and infestations |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils, Soft tissue NOS | Infections and infestations |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS | Infections and infestations |
|
| Infection with unknown ANC, Larynx | Infections and infestations |
|
| Infection with unknown ANC, Oral cavity-gums (gingivitis) | Infections and infestations |
|
| Infection with unknown ANC, Pelvis NOS | Infections and infestations |
|
| Infection with unknown ANC, Bladder (urinary) | Infections and infestations |
|
| Infection with unknown ANC, Bronchus | Infections and infestations |
|
| Infection with unknown ANC, Skin (cellulitis) | Infections and infestations |
|
| Infection with unknown ANC, Upper airway NOS | Infections and infestations |
|
| Infection with unknown ANC, Urinary tract NOS | Infections and infestations |
|
| Edema: head and neck | Blood and lymphatic system disorders |
|
| Lymphatics - Other (Specify, __) | Blood and lymphatic system disorders |
|
| Edema: limb | Blood and lymphatic system disorders |
|
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations |
|
| Phosphate, serum-low (hypophosphatemia) | Investigations |
|
| Potassium, serum-high (hyperkalemia) | Investigations |
|
| Creatinine | Investigations |
|
| Metabolic/Laboratory - Other (Specify, __) | Investigations |
|
| Albumin, serum-low (hypoalbuminemia) | Investigations |
|
| Magnesium, serum-low (hypomagnesemia) | Investigations |
|
| Potassium, serum-low (hypokalemia) | Investigations |
|
| Cholesterol, serum-high (hypercholesteremia) | Investigations |
|
| Glucose, serum-high (hyperglycemia) | Investigations |
|
| Triglyceride, serum-high (hypertriglyceridemia) | Investigations |
|
| Arthritis (non-septic) | Musculoskeletal and connective tissue disorders |
|
| Muscle weakness, generalized or specific area (not due to neuropathy), Extremity-lower | Musculoskeletal and connective tissue disorders |
|
| Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized | Musculoskeletal and connective tissue disorders |
|
| Musculoskeletal/Soft Tissue - Other (Specify, __) | Musculoskeletal and connective tissue disorders |
|
| Extrapyramidal/involuntary movement/restlessness | Nervous system disorders |
|
| Mood alteration, Depression | Nervous system disorders |
|
| Neurology - Other (Specify, __) | Nervous system disorders |
|
| Syncope (fainting) | Nervous system disorders |
|
| Neuropathy: sensory | Nervous system disorders |
|
| Dizziness | Nervous system disorders |
|
| Mood alteration, Anxiety | Nervous system disorders |
|
| Ocular/Visual - Other (Specify, __) | Eye disorders |
|
| Pain, Anus | General disorders |
|
| Pain, Dental/teeth/peridontal | General disorders |
|
| Pain, Extremity-limb | General disorders |
|
| Pain, Neuralgia/peripheral nerve | General disorders |
|
| Pain, Pelvis | General disorders |
|
| Pain, Rectum | General disorders |
|
| Pain, Stomach | General disorders |
|
| Pain, Urethra | General disorders |
|
| Pain, Vagina | General disorders |
|
| Pain, Bone | General disorders |
|
| Pain, Joint | General disorders |
|
| Pain, Back | General disorders |
|
| Pain, Throat/pharynx/larynx | General disorders |
|
| Pain, Muscle | General disorders |
|
| Pain, Pain NOS | General disorders |
|
| Pain - Other (Specify, __) | General disorders |
|
| Pain, Head/headache | General disorders |
|
| Pain, Abdomen NOS | General disorders |
|
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders |
|
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders |
|
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders |
|
| Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary/Upper Respiratory - Other (Specify, __) | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Cystitis | Renal and urinary disorders |
|
| Fistula, GU, Ureter | Renal and urinary disorders |
|
| Obstruction, GU, Ureter | Renal and urinary disorders |
|
| Bladder spasms | Renal and urinary disorders |
|
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders |
|
| Urinary frequency/urgency | Renal and urinary disorders |
|
| Renal/Genitourinary - Other (Specify, __) | Renal and urinary disorders |
|
| Vaginal discharge (non-infectious) | General disorders |
|
| Vaginal mucositis | General disorders |
|
| Flu-like syndrome | General disorders |
|
| Phlebitis (including superficial thrombosis) | Vascular disorders |
|
| Thrombosis/embolism (vascular access-related) | Vascular disorders |
|
| Thrombosis/thrombus/embolism | Vascular disorders |
|
| Vascular - Other (Specify, __) | Vascular disorders |
|
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |