Trial Outcomes & Findings for Vandetanib to Treat Women With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT00445549)
NCT ID: NCT00445549
Last Updated: 2012-06-26
Results Overview
Defined as complete response (CR), partial response (PR), or disease stabilization lasting 6 months or longer per RECIST criteria. CR-total disappearance of all evaluable disease. PR-\>30% reduction in the sum of the longest diameters (LD) of target lesions. Stable disease (SD) is \<30% decrease and \<20% increase in the sum of the LD of all target lesions. See the protocol Link module for full RECIST criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
24 weeks
Results posted on
2012-06-26
Participant Flow
If 2-3 patients per month enroll onto this trial, it is expected that approximately one and a half years will be required to enroll the 35 evaluable patients required for evaluation in this study. To make an allowance for a small drop-out of patients from the study and still preserve the intended accrual goal, the total accrual will be38 patients.
Participant milestones
| Measure |
Vandetanib Treatment
300 mg daily oral dose, 28 day cycle
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Vandetanib Treatment
300 mg daily oral dose, 28 day cycle
|
|---|---|
|
Overall Study
progressive disease
|
12
|
Baseline Characteristics
Vandetanib to Treat Women With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Vandetanib Treatment
n=12 Participants
300 mg daily oral dose, 28 day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
59.13 years
STANDARD_DEVIATION 9.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksDefined as complete response (CR), partial response (PR), or disease stabilization lasting 6 months or longer per RECIST criteria. CR-total disappearance of all evaluable disease. PR-\>30% reduction in the sum of the longest diameters (LD) of target lesions. Stable disease (SD) is \<30% decrease and \<20% increase in the sum of the LD of all target lesions. See the protocol Link module for full RECIST criteria.
Outcome measures
| Measure |
Vandetanib Treatment
n=12 Participants
300 mg daily oral dose, 28 day cycle
|
|---|---|
|
Number of Participants With Clinical Efficacy
|
0 participants
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: 22 monthsHere are the total # of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Vandetanib Treatment
n=12 Participants
300 mg daily oral dose, 28 day cycle
|
|---|---|
|
The Number of Participants With Adverse Events
|
12 Participants
|
Adverse Events
Vandetanib Treatment
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vandetanib Treatment
n=12 participants at risk
300 mg daily oral dose, 28 day cycle
|
|---|---|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
66.7%
8/12 • Number of events 15 • 22 months
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
91.7%
11/12 • Number of events 16 • 22 months
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
75.0%
9/12 • Number of events 14 • 22 months
|
|
Investigations
Alkaline phosphatase
|
33.3%
4/12 • Number of events 6 • 22 months
|
|
Metabolism and nutrition disorders
Anorexia
|
41.7%
5/12 • Number of events 5 • 22 months
|
|
Hepatobiliary disorders
Bilirubin (hyperbilirubinemia)
|
25.0%
3/12 • Number of events 8 • 22 months
|
|
Injury, poisoning and procedural complications
Burn
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Investigations
Creatinine
|
16.7%
2/12 • Number of events 3 • 22 months
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
25.0%
3/12 • Number of events 3 • 22 months
|
|
Gastrointestinal disorders
Diarrhea
|
83.3%
10/12 • Number of events 21 • 22 months
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
16.7%
2/12 • Number of events 4 • 22 months
|
|
General disorders
Edema: limb
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
50.0%
6/12 • Number of events 6 • 22 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
25.0%
3/12 • Number of events 3 • 22 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
33.3%
4/12 • Number of events 6 • 22 months
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Investigations
Hemoglobin
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Investigations
Hemoglobinuria
|
25.0%
3/12 • Number of events 3 • 22 months
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Renal and urinary disorders
Hemorrhage, GU::Ureter
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Reproductive system and breast disorders
Hemorrhage, GU::Vagina
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Vascular disorders
Hot flashes/flushes
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Renal and urinary disorders
Incontinence, urinary
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Vulva
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Vagina
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Infections and infestations
Infection with unknown ANC::Urinary tract NOS
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Psychiatric disorders
Insomnia
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
2/12 • Number of events 3 • 22 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
50.0%
6/12 • Number of events 12 • 22 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • Number of events 4 • 22 months
|
|
Nervous system disorders
Neuropathy: sensory
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Gastrointestinal disorders
Obstruction, GI::Small bowel NOS
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Renal and urinary disorders
Obstruction, GU::Ureter
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
General disorders
Pain::Abdomen NOS
|
41.7%
5/12 • Number of events 6 • 22 months
|
|
General disorders
Pain::Chest/thorax NOS
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Nervous system disorders
Pain::Head/headache
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
8.3%
1/12 • Number of events 2 • 22 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Muscle
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Reproductive system and breast disorders
Pain::Pelvis
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Eye disorders
Photosensitivity
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Blood and lymphatic system disorders
Platelets
|
16.7%
2/12 • Number of events 4 • 22 months
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
33.3%
4/12 • Number of events 5 • 22 months
|
|
Investigations
Prolonged QTc interval
|
66.7%
8/12 • Number of events 13 • 22 months
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
50.0%
6/12 • Number of events 8 • 22 months
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
50.0%
6/12 • Number of events 7 • 22 months
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
33.3%
4/12 • Number of events 5 • 22 months
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
41.7%
5/12 • Number of events 6 • 22 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Eye disorders
Vision-flashing lights/floaters
|
8.3%
1/12 • Number of events 1 • 22 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
16.7%
2/12 • Number of events 2 • 22 months
|
|
Investigations
Weight loss
|
16.7%
2/12 • Number of events 3 • 22 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
3/12 • Number of events 3 • 22 months
|
Additional Information
Elise C. Kohn, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-4916
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place