Trial · NCT01753713
Dovitinib in Treating Patients With Recurrent or Progressive Glioblastoma
NCT01753713, Phase 2, Completed, Manmeet Ahluwalia, MD; results first posted 2017-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dovitinib in Treating Patients With Recurrent or Progressive Glioblastoma. Trials, record NCT01753713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01753713
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dovitinib in Treating Patients With Recurrent or Progressive Glioblastoma
- NCT number
- NCT01753713
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Manmeet Ahluwalia, MD
- Conditions
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
- Interventions
- dovitinib, laboratory biomarker analysis
- First posted
- 2012-12-20
- Last updated
- 2017-12-12
- Results first posted
- 2017-08-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arm 1: Progression Free Survival (PFS) | 6 months | Number of anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) naive patients with recurrent glioblastoma (GBM). The progression- free survival (PFS) at 6 months is defined as the time from randomization to objective tumor progression or death. So patients who have CR, PR or SD at 6 months will constitute PFS-6. Progression is defined using the Response Assessment in Neuro-Oncology (RANO) Criteria where CR = Total disappearance of lesions, PR = \>50% reduction in lesions and SD = \<25% reduction in lesions |
| Primary | Arm 2: Determine Median Time to Progression | From randomization to time of progression every 8 weeks (2 cycles of treatment) up to 32 weeks | Anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) patients with recurrent glioblastoma (GBM). Time to tumor progression (TTP), is defined as the time from randomization to time of progressive disease. So it is ongoing and will be assessed every 8 weeks …8, 16, 24, 32 …week. Progression is defined as \>25% increase in size of lesions or evidence of new lesions |
| Secondary | Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Assessed until 30 days after treatment up to 32 weeks | Number of adverse events in patients in both populations (grade 1-5). Grade 1 are defined as mild events characterized as asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention indicated. Grade 2 are moderate events with minimal, local or non invasive interventions indicated. Grade 3 are severe or medically significant events but not immediately life-threatening; hospitalization indicated. Grade 4 are life-threatening consequences with urgent intervention indicated. Grade 5 are deaths related to events |
| Secondary | Objective Response Rate Using Modified Revised Assessment in Neuro-Oncology (RANO) Criteria | Up to 30 days after treatment | Number of patients (both populations) with a complete response (CR-no measurable disease), partial response (PR \>50% reduction in measurable disease), minor response (MR \>25% reduction of measurable disease), stable disease (SD \<25% reduction) and progressive disease (PD \>25% measurable disease and new lesions). |
| Secondary | Median Progression Free Survival | 6 months | The progression- free survival (PFS) at 6 months is defined as the time from randomization to objective tumor progression or death. So patients who have CR, PR or SD at 6 months will constitute PFS-6 |
| Secondary | Overall Survival | to death, approximately 2 years | The Kaplan-Meier method will be used. Overall survival is defined as the time from randomization to death. |
| Other | Changes From Baseline in Circulating Growth Factors and Soluble Receptors. | Up to 30 days after treatment | To assess the pharmacodynamic effect of dovitinib on potential plasma biomarkers that may include measuring concentrations of circulating, microparticles, PlGF, PDGF-AA, PDGF-AB, PDGF-BB, SDF-la, thrombospondin-l, Angl, and 11-6, IL-8 and FGF. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Arm 1: Progression Free Survival (PFS) | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Arm 2: Determine Median Time to Progression | From randomization to time of progression every 8 weeks (2 cycles of treatment) up to 32 weeks | Months | MEDIAN | |
| SECONDARY | Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Assessed until 30 days after treatment up to 32 weeks | Events | NUMBER | |
| SECONDARY | Objective Response Rate Using Modified Revised Assessment in Neuro-Oncology (RANO) Criteria | Up to 30 days after treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Progression Free Survival | 6 months | Months | MEDIAN | |
| SECONDARY | Overall Survival | to death, approximately 2 years | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Changes From Baseline in Circulating Growth Factors and Soluble Receptors. | Up to 30 days after treatment |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Arm 1: Progression Free Survival (PFS) | Anti-angiogenic Therapy Naive Patients | 0 | Participants | ||
| Arm 1: Progression Free Survival (PFS) | Anti-angiogenic Therapy Patients | 0 | Participants | ||
| Arm 2: Determine Median Time to Progression | Anti-angiogenic Therapy Naive Patients | 1.8 | 95% Confidence Interval 1.3 to 2.8 | Months | |
| Arm 2: Determine Median Time to Progression | Anti-angiogenic Therapy Patients | 1.8 | 95% Confidence Interval 0.7 to 1.8 | Months | |
| Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Anti-angiogenic Therapy Naive Patients | Grade 1 | 217 | Events | |
| Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Anti-angiogenic Therapy Patients | Grade 1 | 119 | Events | |
| Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Anti-angiogenic Therapy Naive Patients | Grade 2 | 109 | Events | |
| Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Anti-angiogenic Therapy Patients | Grade 2 | 85 | Events | |
| Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Anti-angiogenic Therapy Naive Patients | Grade 3 | 55 | Events | |
| Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Anti-angiogenic Therapy Patients | Grade 3 | 40 | Events |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anti-angiogenic Therapy Patients | 14 | |
| Overall Study | STARTED | Anti-angiogenic Therapy Naive Patients | 19 | |
| Overall Study | COMPLETED | Anti-angiogenic Therapy Patients | 14 | |
| Overall Study | COMPLETED | Anti-angiogenic Therapy Naive Patients | 19 | |
| Overall Study | NOT COMPLETED | Anti-angiogenic Therapy Patients | 0 | |
| Overall Study | NOT COMPLETED | Anti-angiogenic Therapy Naive Patients | 0 |
Source ClinicalTrials.gov
Adverse events294
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 | Alanine aminotransferase increased | Investigations | Anti-angiogenic Therapy Naive Patients | 12 | 19 | 16 |
| other | Alanine aminotransferase increased | Investigations | Anti-angiogenic Therapy Patients | 11 | 14 | 15 |
| other | Platelet count decreased | Investigations | Anti-angiogenic Therapy Naive Patients | 13 | 19 | 17 |
| other | Platelet count decreased | Investigations | Anti-angiogenic Therapy Patients | 10 | 14 | 19 |
| other | Lymphocyte count decreased | Investigations | Anti-angiogenic Therapy Naive Patients | 12 | 19 | 20 |
| other | Lymphocyte count decreased | Investigations | Anti-angiogenic Therapy Patients | 6 | 14 | 8 |
| other | Aspartate aminotransferase increased | Investigations | Anti-angiogenic Therapy Naive Patients | 5 | 19 | 9 |
| other | Aspartate aminotransferase increased | Investigations | Anti-angiogenic Therapy Patients | 6 | 14 | 8 |
| other | Lipase increased | Investigations | Anti-angiogenic Therapy Naive Patients | 7 | 19 | 12 |
| other | Lipase increased | Investigations | Anti-angiogenic Therapy Patients | 4 | 14 | 6 |
1 to 10 of 294Source ClinicalTrials.gov
See all 294 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anti-angiogenic Therapy Naive Patients | 1 | 19 |
| Total, all-cause mortality | Anti-angiogenic Therapy Patients | 2 | 14 |
| Total, other adverse events | Anti-angiogenic Therapy Naive Patients | 19 | 19 |
| Total, other adverse events | Anti-angiogenic Therapy Patients | 14 | 14 |
| Total, serious adverse events | Anti-angiogenic Therapy Naive Patients | 10 | 19 |
| Total, serious adverse events | Anti-angiogenic Therapy Patients | 7 | 14 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anti-angiogenic Therapy Naive Patients vs Anti-angiogenic Therapy Patients: Arm 1: Progression Free Survival (PFS) | Trial comparisons |
| Anti-angiogenic Therapy Naive Patients vs Anti-angiogenic Therapy Patients: deaths from any cause | Trial comparisons |
| Anti-angiogenic Therapy Naive Patients vs Anti-angiogenic Therapy Patients: 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/NCT01753713
GET https://conductscience.org/api/trials/v1/NCT01753713/results?page=2