Trial · NCT01931098
Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab
NCT01931098, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-09-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab. Trials, record NCT01931098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01931098
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab
- NCT number
- NCT01931098
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Gliosarcoma, Brain Neoplasms, Central Nervous System Neoplasms
- Interventions
- topotecan, pazopanib
- First posted
- 2013-08-29
- Last updated
- 2025-08-11
- Results first posted
- 2020-09-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients That Have Progressive Survival (PFS) at Six Months From Patient Registration for Bevacizumab Naive Patients and PFS at 3 Months for Patients With Prior Bevacizumab Treatment | six months from patient registration for bevacizumab naive patients, and 3 months from patient registration for patients with prior bevacizumab treatment | PFS was evaluated using the Kaplan-Meier product-limit survival curve methodology. For participants with no prior bevacizumab exposure, PFS is defined as 2 or more participants who are progression free at 6 months. For participants with prior bevacizumab exposure, PFS is defined as 1 or more participants who are progression free at 3 months. Progression is a 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) or clear worsening of evaluable disease or the appearance of any new lesions. |
| Secondary | Overall Survival | From date of registration to date of death due to any cause, up to 5 years. | OS was evaluated using the Kaplan-Meier product-limit survival curve methodology and is defined as the time from date of registration to date of death due to any cause. |
| Secondary | Mean Symptom Severity Score Between Responders and Non-responders at Baseline and by Cycle | Baseline, and Cycles 1-6 | Responders and Non-Responders symptom presence and severity were assessed by the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) questionnaire using an scale of (0-10); 0 being not present and 10 being the worst, and Responders were defined as patients with stable disease (SD) and partial response (PR) as their best response, and Non-responders were defined as patients with disease progression (PD) as their best response. Partial response is greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesion. Progressive disease is a 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease). And stable disease does not qualify for complete response, partial response or progression. |
| Secondary | Mean Symptom Interference Score Between Responders and Non-responders at Baseline and by Cycle | Baseline, and Cycles 1-6 | Responders and Non-Responders symptom interference was assessed by the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) questionnaire that determined how much general activity, mood, work inside and outside the home, relations with other people, walking and enjoying life interfered with a participant's life rated on an scale (0-10); 0 being not present and 10 being the worst. Responders were defined as patients with stable disease (SD) and partial response (PR) as their best response, and Non-responders were defined as patients with disease progression (PD) as their best response. Partial response is greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesion. Progressive disease is a 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease). And stable disease does not qualify for complete response, partial response or progression. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 20 months and 18 days for the first Arm/Group, and 28 months and 23 days for the second Arm/Group. | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients That Have Progressive Survival (PFS) at Six Months From Patient Registration for Bevacizumab Naive Patients and PFS at 3 Months for Patients With Prior Bevacizumab Treatment | six months from patient registration for bevacizumab naive patients, and 3 months from patient registration for patients with prior bevacizumab treatment | proportion of participants | NUMBER | |
| SECONDARY | Overall Survival | From date of registration to date of death due to any cause, up to 5 years. | Months | MEDIAN | |
| SECONDARY | Mean Symptom Severity Score Between Responders and Non-responders at Baseline and by Cycle | Baseline, and Cycles 1-6 | One participant in the second Arm/Group did not have a best response recorded and was excluded from questions involving responders and non-responders. | scores on a scale | MEAN |
| SECONDARY | Mean Symptom Interference Score Between Responders and Non-responders at Baseline and by Cycle | Baseline, and Cycles 1-6 | One participant in the second Arm/Group did not have a best response recorded and was excluded from questions involving responders and non-responders. | scores on a scale | MEAN |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 20 months and 18 days for the first Arm/Group, and 28 months and 23 days for the second Arm/Group. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients That Have Progressive Survival (PFS) at Six Months From Patient Registration for Bevacizumab Naive Patients and PFS at 3 Months for Patients With Prior Bevacizumab Treatment | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 3 months | 0.44 | 95% Confidence Interval 0.14 to 0.72 | proportion of participants |
| Proportion of Patients That Have Progressive Survival (PFS) at Six Months From Patient Registration for Bevacizumab Naive Patients and PFS at 3 Months for Patients With Prior Bevacizumab Treatment | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 3 months | 0.18 | 95% Confidence Interval 0.06 to 0.36 | proportion of participants |
| Proportion of Patients That Have Progressive Survival (PFS) at Six Months From Patient Registration for Bevacizumab Naive Patients and PFS at 3 Months for Patients With Prior Bevacizumab Treatment | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 6 months | 0.11 | 95% Confidence Interval 0.01 to 0.39 | proportion of participants |
| Proportion of Patients That Have Progressive Survival (PFS) at Six Months From Patient Registration for Bevacizumab Naive Patients and PFS at 3 Months for Patients With Prior Bevacizumab Treatment | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 6 months | 0 | 95% Confidence Interval 0 to 0 | proportion of participants |
| Overall Survival | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 7.1 | 95% Confidence Interval 2.9 to 8.2 | Months | |
| Overall Survival | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 6.3 | 95% Confidence Interval 2.8 to 9.1 | Months | |
| Mean Symptom Severity Score Between Responders and Non-responders at Baseline and by Cycle | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | Responders - baseline | 1.1 | Standard Deviation 0.4 | scores on a scale |
| Mean Symptom Severity Score Between Responders and Non-responders at Baseline and by Cycle | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | Responders - baseline | 1.9 | Standard Deviation 1.3 | scores on a scale |
| Mean Symptom Severity Score Between Responders and Non-responders at Baseline and by Cycle | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | Responders - Cycle 1 | 2.3 | Standard Deviation 1.4 | scores on a scale |
| Mean Symptom Severity Score Between Responders and Non-responders at Baseline and by Cycle | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | Responders - Cycle 2 | 0.8 | Standard Deviation 0.4 | scores on a scale |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 9 | |
| Overall Study | STARTED | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 26 | |
| Overall Study | COMPLETED | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 9 | |
| Overall Study | COMPLETED | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 22 | |
| Overall Study | NOT COMPLETED | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 0 | |
| Overall Study | NOT COMPLETED | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 4 |
Source ClinicalTrials.gov
Adverse events230
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 | Abdominal pain | Gastrointestinal disorders | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 0 | 9 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 2 | 26 | 3 |
| other | Alanine aminotransferase increased | Investigations | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 1 | 9 | 2 |
| other | Alanine aminotransferase increased | Investigations | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 2 | 26 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 1 | 9 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 2 | 26 | 2 |
| other | Anorexia | Metabolism and nutrition disorders | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 2 | 9 | 2 |
| other | Anorexia | Metabolism and nutrition disorders | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 6 | 26 | 6 |
| other | Anxiety | Psychiatric disorders | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 0 | 9 | 0 |
| other | Anxiety | Psychiatric disorders | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 1 | 26 | 1 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 9 | 9 |
| Total, all-cause mortality | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 20 | 26 |
| Total, other adverse events | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 9 | 9 |
| Total, other adverse events | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 21 | 26 |
| Total, serious adverse events | Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure | 2 | 9 |
| Total, serious adverse events | Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure | 7 | 26 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure vs Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure: Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Trial comparisons |
| Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure vs Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure: deaths from any cause | Trial comparisons |
| Glioblastoma or Gliosarcoma With No Prior Bevacizumab Exposure vs Glioblastoma or Gliosarcoma With Prior Bevacizumab Exposure: serious adverse events | Trial comparisons |
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/NCT01931098
GET https://conductscience.org/api/trials/v1/NCT01931098/results?page=2