Trial Outcomes & Findings for Vatalanib in Treating Patients With Recurrent or Progressive Meningioma (NCT NCT00348790)
NCT ID: NCT00348790
Last Updated: 2018-10-26
Results Overview
Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatment
Results posted on
2018-10-26
Participant Flow
Participant milestones
| Measure |
Vatalanib
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
|
|---|---|
|
Began Treatment
STARTED
|
25
|
|
Began Treatment
COMPLETED
|
25
|
|
Began Treatment
NOT COMPLETED
|
0
|
|
Completed Treatment
STARTED
|
25
|
|
Completed Treatment
COMPLETED
|
0
|
|
Completed Treatment
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Vatalanib
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
|
|---|---|
|
Completed Treatment
Withdrawal by Subject
|
4
|
|
Completed Treatment
Disease progression
|
14
|
|
Completed Treatment
Adverse Event
|
4
|
|
Completed Treatment
Required surgery
|
2
|
|
Completed Treatment
Unable to travel to study site
|
1
|
Baseline Characteristics
Vatalanib in Treating Patients With Recurrent or Progressive Meningioma
Baseline characteristics by cohort
| Measure |
Vatalanib
n=25 Participants
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
|
|---|---|
|
Age, Customized
21-30
|
1 participants
n=99 Participants
|
|
Age, Customized
31-40
|
1 participants
n=99 Participants
|
|
Age, Customized
41-50
|
6 participants
n=99 Participants
|
|
Age, Customized
51-60
|
8 participants
n=99 Participants
|
|
Age, Customized
61-70 years
|
8 participants
n=99 Participants
|
|
Age, Customized
71-80
|
0 participants
n=99 Participants
|
|
Age, Customized
81-90
|
1 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatmentPatients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted.
Outcome measures
| Measure |
Vatalanib
n=25 Participants
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
|
|---|---|
|
Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.
|
15 Participants
|
SECONDARY outcome
Timeframe: At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatmentPopulation: Data not collected. Statistical design of study was based on participation of patients with WHO grade I meningioma. Most patients enrolled in the study were WHO grade II and WHO grade III.
Efficacy will be assessed by MRI scan and neurological exam upon study entry, every 2 weeks for 2 months, then every 8 weeks while on treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 2 months for up to 1 year after study treatment.Population: 3 patients not evaluable.
Overall Response Rate (ORR) will be as assessed by MRI scan every 2 months while on study treatment and follow-up for up to 1 year after discontinuation of study treatment. The RR is the best response recorded from the start of the treatment until disease progression (PD) where the following definitions apply. Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable/No Response: Does not qualify for CR, PR, or PD Progressive disease (PD):25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) worsening of evaluable disease, new lesions, clinical worsening OR failure to return for evaluation due to death/deteriorating condition
Outcome measures
| Measure |
Vatalanib
n=22 Participants
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
|
|---|---|
|
Best Overall Response Rate (ORR)
SD
|
15 Participants
|
|
Best Overall Response Rate (ORR)
SD on MRI but clinical decline
|
2 Participants
|
|
Best Overall Response Rate (ORR)
PD
|
5 Participants
|
SECONDARY outcome
Timeframe: At the end of study treatmentPopulation: Data not collected and analyzed.
Correlation of response rates with the expression of certain types of genes will be assessed by examining tissue samples taken from previous surgery and testing for certain genes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every week while on study treatment until 30 days after last treatment.Population: Toxicities determined to be either grade 3 or grade 4 and at least possibly related to study drug are reported here.
Safety of vatalanib will be assessed using National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE) 3.0 and graded using the following: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Fatal
Outcome measures
| Measure |
Vatalanib
n=25 Participants
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
|
|---|---|
|
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Dehydration
|
1 participants
|
|
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Deep vein thrombosis
|
1 participants
|
|
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Fatigue
|
4 participants
|
|
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Gastrointestinal
|
1 participants
|
|
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Hypertension
|
1 participants
|
|
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Hyponatremia
|
1 participants
|
|
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Leukopenia
|
1 participants
|
|
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Pain
|
1 participants
|
|
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Rash
|
1 participants
|
|
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Transaminase
|
2 participants
|
|
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Weight loss
|
1 participants
|
SECONDARY outcome
Timeframe: From the date the first patient began treatment until the date the last patient became deceased.Outcome measures
| Measure |
Vatalanib
n=25 Participants
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
|
|---|---|
|
Number of Months Patients Survive After Being Treatment on the Study.
|
29.2 months
Interval 15.0 to 50.0
|
SECONDARY outcome
Timeframe: Every 2 months for up to 1 year after study treatment.Population: Number of patients with WHO grade II or WHO grade III meningioma.
Overall Survival will be measured from the first treatment on study until death of any cause.
Outcome measures
| Measure |
Vatalanib
n=21 Participants
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
|
|---|---|
|
Overall Survival (OS)
|
26 Months
Interval 4.27 to 76.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatmentPopulation: Data not collected and analyzed.
Data concerning certain genes that cause tumors to grow new blood vessels will be examined by MRI scan with MR Perfusion done before treatment and then every 2 months while on study treatment
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline and then every time an MRI is performed while on study treatment.Population: Data not collected or analyzed.
FACT BR questionnaire will be used to measure quality of life at baseline and then every time an MRI scan is performed while on study treatment
Outcome measures
Outcome data not reported
Adverse Events
Vatalanib
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vatalanib
n=25 participants at risk
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
vatalanib
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
4.0%
1/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Nervous system disorders
Headache
|
4.0%
1/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
1/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Scalp wound
|
4.0%
1/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
4.0%
1/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
Other adverse events
| Measure |
Vatalanib
n=25 participants at risk
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
vatalanib
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Blood and lymphatic system disorders
Platelets
|
12.0%
3/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Renal and urinary disorders
Hematuria
|
12.0%
3/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
24.0%
6/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
24.0%
6/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
16.0%
4/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
5/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Cardiac disorders
Hypertension
|
32.0%
8/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.0%
3/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
General disorders
Fatigue
|
76.0%
19/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Nervous system disorders
Neuropathy: Sensory-facial
|
16.0%
4/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Nervous system disorders
Neuropathy - Motor
|
16.0%
4/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
24.0%
6/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Nervous system disorders
Headache
|
48.0%
12/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Investigations
Weight loss
|
12.0%
3/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Transaminase
|
60.0%
15/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
12.0%
3/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Creatinine
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
24.0%
6/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.0%
3/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
General disorders
Insomnia
|
20.0%
5/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Cardiac disorders
T wave abnormalities/changes
|
12.0%
3/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.0%
4/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Psychiatric disorders
Depression
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.0%
3/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Nervous system disorders
Seizure
|
12.0%
3/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
5/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Eye disorders
Vision loss
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Metabolism and nutrition disorders
Proteinuria
|
20.0%
5/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Nervous system disorders
Spasm
|
12.0%
3/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
|
Nervous system disorders
Confusion
|
8.0%
2/25
Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place