Trial Outcomes & Findings for Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer (NCT NCT01031381)
NCT ID: NCT01031381
Last Updated: 2016-08-30
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 36 months (data collection period for the cohort); Up to 6 months for participant
Results posted on
2016-08-30
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
RAD001 + Bevacizumab
n=50 Participants
Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
|
|---|---|
|
Age, Continuous
|
60.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 36 months (data collection period for the cohort); Up to 6 months for participantPopulation: 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
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).
Outcome measures
| Measure |
RAD001 + Bevacizumab
n=50 Participants
Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously.
|
|---|---|
|
Progression-free Survival (PFS) at 6-months
|
28 percentage of participants
Interval 16.67 to 42.71
|
SECONDARY outcome
Timeframe: Within 4 weeks (28 days) of study treatment initiation (baseline)Population: 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
The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Outcome measures
| Measure |
RAD001 + Bevacizumab
n=50 Participants
Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously.
|
|---|---|
|
Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)
|
4 participants
|
Adverse Events
RAD001 + Bevacizumab
Serious events: 19 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAD001 + Bevacizumab
n=50 participants at risk
Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
|
|---|---|
|
Cardiac disorders
Cardiac General - Other (Specify, __)
|
2.0%
1/50
|
|
Cardiac disorders
Hypertension
|
2.0%
1/50
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
2.0%
1/50
|
|
Gastrointestinal disorders
Dehydration
|
2.0%
1/50
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/50
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
2.0%
1/50
|
|
Gastrointestinal disorders
Fistula, GI, Colon/cecum/appendix
|
2.0%
1/50
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
2.0%
1/50
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
4.0%
2/50
|
|
Gastrointestinal disorders
Obstruction, GI, Ileum
|
2.0%
1/50
|
|
Gastrointestinal disorders
Obstruction, GI, Small bowel NOS
|
6.0%
3/50
|
|
Renal and urinary disorders
Hemorrhage, GU, Bladder
|
2.0%
1/50
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
2.0%
1/50
|
|
Infections and infestations
Infection with unknown ANC, Lung (pneumonia)
|
4.0%
2/50
|
|
Infections and infestations
Infection with unknown ANC, Urinary tract NOS
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Left-sided
|
2.0%
1/50
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
2.0%
1/50
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
2.0%
1/50
|
|
General disorders
Pain, Abdomen NOS
|
4.0%
2/50
|
|
General disorders
Pain, Rectum
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
4.0%
2/50
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.0%
1/50
|
Other adverse events
| Measure |
RAD001 + Bevacizumab
n=50 participants at risk
Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
|
|---|---|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
14.0%
7/50
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, __)
|
2.0%
1/50
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
2.0%
1/50
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
4.0%
2/50
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.0%
3/50
|
|
Blood and lymphatic system disorders
Platelets
|
8.0%
4/50
|
|
Blood and lymphatic system disorders
Hemoglobin
|
18.0%
9/50
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Atrial fibrillation
|
2.0%
1/50
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Sinus bradycardia
|
2.0%
1/50
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, __)
|
4.0%
2/50
|
|
Cardiac disorders
Palpitations
|
4.0%
2/50
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Sinus tachycardia
|
6.0%
3/50
|
|
Cardiac disorders
Hypertension
|
34.0%
17/50
|
|
General disorders
Rigors/chills
|
4.0%
2/50
|
|
General disorders
Sweating (diaphoresis)
|
4.0%
2/50
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
6.0%
3/50
|
|
General disorders
Insomnia
|
6.0%
3/50
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
10.0%
5/50
|
|
General disorders
Weight loss
|
16.0%
8/50
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
60.0%
30/50
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation, Chemoradiation
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Wound complication, non-infectious
|
2.0%
1/50
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
4.0%
2/50
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.0%
2/50
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
6.0%
3/50
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
4/50
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
10.0%
5/50
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
28.0%
14/50
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.0%
1/50
|
|
Gastrointestinal disorders
Esophagitis
|
2.0%
1/50
|
|
Gastrointestinal disorders
Fistula, GI, Colon/cecum/appendix
|
2.0%
1/50
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
2.0%
1/50
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Larynx
|
2.0%
1/50
|
|
Gastrointestinal disorders
Proctitis
|
2.0%
1/50
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
4.0%
2/50
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.0%
2/50
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Anus
|
4.0%
2/50
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Rectum
|
4.0%
2/50
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
4.0%
2/50
|
|
Gastrointestinal disorders
Flatulence
|
6.0%
3/50
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
6.0%
3/50
|
|
Gastrointestinal disorders
Dehydration
|
8.0%
4/50
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic), Oral cavity
|
8.0%
4/50
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
12.0%
6/50
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
14.0%
7/50
|
|
Gastrointestinal disorders
Dental: teeth
|
16.0%
8/50
|
|
Gastrointestinal disorders
Constipation
|
22.0%
11/50
|
|
Gastrointestinal disorders
Vomiting
|
26.0%
13/50
|
|
Gastrointestinal disorders
Anorexia
|
34.0%
17/50
|
|
Gastrointestinal disorders
Nausea
|
40.0%
20/50
|
|
Gastrointestinal disorders
Diarrhea
|
44.0%
22/50
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
64.0%
32/50
|
|
Vascular disorders
Hematoma
|
2.0%
1/50
|
|
Vascular disorders
Hemorrhage, GI, Anus
|
4.0%
2/50
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify, __)
|
4.0%
2/50
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory, Nose
|
16.0%
8/50
|
|
Infections and infestations
Infection - Other (Specify, __)
|
2.0%
1/50
|
|
Infections and infestations
Infection (documented) Urinary tract NOS
|
2.0%
1/50
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Bladder (urinary)
|
2.0%
1/50
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Soft tissue NOS
|
2.0%
1/50
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS
|
2.0%
1/50
|
|
Infections and infestations
Infection with unknown ANC, Larynx
|
2.0%
1/50
|
|
Infections and infestations
Infection with unknown ANC, Oral cavity-gums (gingivitis)
|
2.0%
1/50
|
|
Infections and infestations
Infection with unknown ANC, Pelvis NOS
|
2.0%
1/50
|
|
Infections and infestations
Infection with unknown ANC, Bladder (urinary)
|
4.0%
2/50
|
|
Infections and infestations
Infection with unknown ANC, Bronchus
|
4.0%
2/50
|
|
Infections and infestations
Infection with unknown ANC, Skin (cellulitis)
|
4.0%
2/50
|
|
Infections and infestations
Infection with unknown ANC, Upper airway NOS
|
4.0%
2/50
|
|
Infections and infestations
Infection with unknown ANC, Urinary tract NOS
|
10.0%
5/50
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
2.0%
1/50
|
|
Blood and lymphatic system disorders
Lymphatics - Other (Specify, __)
|
4.0%
2/50
|
|
Blood and lymphatic system disorders
Edema: limb
|
14.0%
7/50
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
2.0%
1/50
|
|
Investigations
Phosphate, serum-low (hypophosphatemia)
|
2.0%
1/50
|
|
Investigations
Potassium, serum-high (hyperkalemia)
|
2.0%
1/50
|
|
Investigations
Creatinine
|
4.0%
2/50
|
|
Investigations
Metabolic/Laboratory - Other (Specify, __)
|
4.0%
2/50
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
6.0%
3/50
|
|
Investigations
Magnesium, serum-low (hypomagnesemia)
|
6.0%
3/50
|
|
Investigations
Potassium, serum-low (hypokalemia)
|
8.0%
4/50
|
|
Investigations
Cholesterol, serum-high (hypercholesteremia)
|
10.0%
5/50
|
|
Investigations
Glucose, serum-high (hyperglycemia)
|
14.0%
7/50
|
|
Investigations
Triglyceride, serum-high (hypertriglyceridemia)
|
14.0%
7/50
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Extremity-lower
|
2.0%
1/50
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized
|
10.0%
5/50
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
14.0%
7/50
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
2.0%
1/50
|
|
Nervous system disorders
Mood alteration, Depression
|
2.0%
1/50
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
2.0%
1/50
|
|
Nervous system disorders
Syncope (fainting)
|
2.0%
1/50
|
|
Nervous system disorders
Neuropathy: sensory
|
6.0%
3/50
|
|
Nervous system disorders
Dizziness
|
8.0%
4/50
|
|
Nervous system disorders
Mood alteration, Anxiety
|
12.0%
6/50
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
2.0%
1/50
|
|
General disorders
Pain, Anus
|
2.0%
1/50
|
|
General disorders
Pain, Dental/teeth/peridontal
|
2.0%
1/50
|
|
General disorders
Pain, Extremity-limb
|
2.0%
1/50
|
|
General disorders
Pain, Neuralgia/peripheral nerve
|
2.0%
1/50
|
|
General disorders
Pain, Pelvis
|
2.0%
1/50
|
|
General disorders
Pain, Rectum
|
2.0%
1/50
|
|
General disorders
Pain, Stomach
|
2.0%
1/50
|
|
General disorders
Pain, Urethra
|
2.0%
1/50
|
|
General disorders
Pain, Vagina
|
2.0%
1/50
|
|
General disorders
Pain, Bone
|
6.0%
3/50
|
|
General disorders
Pain, Joint
|
6.0%
3/50
|
|
General disorders
Pain, Back
|
8.0%
4/50
|
|
General disorders
Pain, Throat/pharynx/larynx
|
8.0%
4/50
|
|
General disorders
Pain, Muscle
|
12.0%
6/50
|
|
General disorders
Pain, Pain NOS
|
12.0%
6/50
|
|
General disorders
Pain - Other (Specify, __)
|
22.0%
11/50
|
|
General disorders
Pain, Head/headache
|
28.0%
14/50
|
|
General disorders
Pain, Abdomen NOS
|
42.0%
21/50
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.0%
1/50
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
4.0%
2/50
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
6.0%
3/50
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
12.0%
6/50
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
16.0%
8/50
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.0%
9/50
|
|
Renal and urinary disorders
Cystitis
|
2.0%
1/50
|
|
Renal and urinary disorders
Fistula, GU, Ureter
|
2.0%
1/50
|
|
Renal and urinary disorders
Obstruction, GU, Ureter
|
2.0%
1/50
|
|
Renal and urinary disorders
Bladder spasms
|
4.0%
2/50
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
4.0%
2/50
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
10.0%
5/50
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
12.0%
6/50
|
|
General disorders
Vaginal discharge (non-infectious)
|
4.0%
2/50
|
|
General disorders
Vaginal mucositis
|
6.0%
3/50
|
|
General disorders
Flu-like syndrome
|
12.0%
6/50
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
2.0%
1/50
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
2.0%
1/50
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.0%
1/50
|
|
Vascular disorders
Vascular - Other (Specify, __)
|
2.0%
1/50
|
Additional Information
Rita Johnson, Associate Director of Clinical Research Services
UPMC Cancer Centers
Phone: 412-647-8571
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place