Trial · NCT00348790
Vatalanib in Treating Patients With Recurrent or Progressive Meningioma
NCT00348790, Phase 2, Completed, Northwestern University; results first posted 2014-10-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vatalanib in Treating Patients With Recurrent or Progressive Meningioma. Trials, record NCT00348790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00348790
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vatalanib in Treating Patients With Recurrent or Progressive Meningioma
- NCT number
- NCT00348790
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Brain and Central Nervous System Tumors, Sarcoma
- Interventions
- vatalanib
- First posted
- 2006-07-06
- Last updated
- 2018-10-26
- Results first posted
- 2014-10-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment. | 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 | 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. |
| Secondary | Determine Efficacy (Radiographic and Clinical Improvement) | At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment | 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 |
| Secondary | Best Overall Response Rate (ORR) | Every 2 months for up to 1 year after study treatment. | 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 |
| Secondary | To Correlate the Response Rates With Expression of Certain Types of Genes | At the end of study treatment | 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 |
| Secondary | Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas | Every week while on study treatment until 30 days after last treatment. | 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 |
| Secondary | Number of Months Patients Survive After Being Treatment on the Study. | From the date the first patient began treatment until the date the last patient became deceased. | |
| Secondary | Overall Survival (OS) | Every 2 months for up to 1 year after study treatment. | Overall Survival will be measured from the first treatment on study until death of any cause. |
| Other | Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels | MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment | 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 |
| Other | To Use the FACT BR Questionnaire to Measure Quality of Life | At baseline and then every time an MRI is performed while on study treatment. | 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 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment. | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Determine Efficacy (Radiographic and Clinical Improvement) | At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment | 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. | ||
| SECONDARY | Best Overall Response Rate (ORR) | Every 2 months for up to 1 year after study treatment. | 3 patients not evaluable. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | To Correlate the Response Rates With Expression of Certain Types of Genes | At the end of study treatment | Data not collected and analyzed. | ||
| SECONDARY | Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas | Every week while on study treatment until 30 days after last treatment. | Toxicities determined to be either grade 3 or grade 4 and at least possibly related to study drug are reported here. | participants | NUMBER |
| SECONDARY | Number of Months Patients Survive After Being Treatment on the Study. | From the date the first patient began treatment until the date the last patient became deceased. | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Every 2 months for up to 1 year after study treatment. | Number of patients with WHO grade II or WHO grade III meningioma. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels | MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment | Data not collected and analyzed. | ||
| OTHER_PRE_SPECIFIED | To Use the FACT BR Questionnaire to Measure Quality of Life | At baseline and then every time an MRI is performed while on study treatment. | Data not collected or analyzed. |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment. | Vatalanib | 15 | Participants | ||
| Best Overall Response Rate (ORR) | Vatalanib | SD | 15 | Participants | |
| Best Overall Response Rate (ORR) | Vatalanib | SD on MRI but clinical decline | 2 | Participants | |
| Best Overall Response Rate (ORR) | Vatalanib | PD | 5 | Participants | |
| Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas | Vatalanib | Dehydration | 1 | participants | |
| Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas | Vatalanib | Deep vein thrombosis | 1 | participants | |
| Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas | Vatalanib | Fatigue | 4 | participants | |
| Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas | Vatalanib | Gastrointestinal | 1 | participants | |
| Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas | Vatalanib | Hypertension | 1 | participants | |
| Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas | Vatalanib | Hyponatremia | 1 | participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Began Treatment | STARTED | Vatalanib | 25 | |
| Began Treatment | COMPLETED | Vatalanib | 25 | |
| Began Treatment | NOT COMPLETED | Vatalanib | 0 | |
| Completed Treatment | STARTED | Vatalanib | 25 | |
| Completed Treatment | COMPLETED | Vatalanib | 0 | |
| Completed Treatment | NOT COMPLETED | Vatalanib | 25 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Vatalanib | 2 | 25 | |
| other | Platelets | Blood and lymphatic system disorders | Vatalanib | 3 | 25 | |
| other | Hematuria | Renal and urinary disorders | Vatalanib | 3 | 25 | |
| other | Nausea | Gastrointestinal disorders | Vatalanib | 6 | 25 | |
| other | Vomiting | Gastrointestinal disorders | Vatalanib | 6 | 25 | |
| other | Stomatitis | Gastrointestinal disorders | Vatalanib | 4 | 25 | |
| other | Diarrhea | Gastrointestinal disorders | Vatalanib | 5 | 25 | |
| other | Hypertension | Cardiac disorders | Vatalanib | 8 | 25 | |
| other | Rash | Skin and subcutaneous tissue disorders | Vatalanib | 3 | 25 | |
| other | Fatigue | General disorders | Vatalanib | 19 | 25 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vatalanib | ||
| Total, other adverse events | Vatalanib | 23 | 25 |
| Total, serious adverse events | Vatalanib | 6 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00348790
GET https://conductscience.org/api/trials/v1/NCT00348790/events?page=2