Trial · NCT03032484
TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma
NCT03032484, Phase 2, Completed, The University of Texas Health Science Center at San Antonio; results first posted 2023-06-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma. Trials, record NCT03032484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03032484
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma
- NCT number
- NCT03032484
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Conditions
- Astrocytoma
- Interventions
- Bevacizumab, TVB-2640
- First posted
- 2017-01-26
- Last updated
- 2023-06-15
- Results first posted
- 2023-06-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival at 6 Months (PFS6) | 6 months | Survival of participants at 6 months after the start of treatment without their condition becoming any worse. Brain magnetic resonance imaging (MRI) was performed after every even cycle (e.g., C2, C4) during treatment, with tumor response assessed by the investigator for complete response (CR), partial response (PR) and PD according to the Response Assessment in Neuro-oncology (RANO) criteria. |
| Secondary | Incidence, Nature and Severity of Adverse Events and Serious Adverse Events, Graded According to NCI - Common Toxicity Criteria for Adverse Events Version (4.03) | Up to 6 28-day cycles | Number of adverse of any nature are reported as well as the number of adverse events that were classed as grade 3-5 on the NCI - Common Toxicity Criteria for Adverse Events |
| Other | Metabolic Change Analysis of Tumor Tissue by MRS (Magnetic Resonance Spectroscopy) | Cycle 2: approximately 56 days | The MRI was performed during cycle 2. This procedure was intended to be outsourced, and MRIs performed locally produced inadequate resolution, so no data analysis was obtained from this measure. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival at 6 Months (PFS6) | 6 months | percentage of participants | NUMBER | |
| SECONDARY | Incidence, Nature and Severity of Adverse Events and Serious Adverse Events, Graded According to NCI - Common Toxicity Criteria for Adverse Events Version (4.03) | Up to 6 28-day cycles | Subject who received TVB-2640 and Bevacizumab or Bevacizumab alone | number of events | NUMBER |
| OTHER_PRE_SPECIFIED | Metabolic Change Analysis of Tumor Tissue by MRS (Magnetic Resonance Spectroscopy) | Cycle 2: approximately 56 days | Data were not evaluable for this measure, since MRI resolution was inadequate |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival at 6 Months (PFS6) | Bevacizumab and TVB-2640 | 47 | percentage of participants | ||
| Incidence, Nature and Severity of Adverse Events and Serious Adverse Events, Graded According to NCI - Common Toxicity Criteria for Adverse Events Version (4.03) | Bevacizumab and TVB-2640 | Number of adverse events any grade | 183 | number of events | |
| Incidence, Nature and Severity of Adverse Events and Serious Adverse Events, Graded According to NCI - Common Toxicity Criteria for Adverse Events Version (4.03) | Bevacizumab and TVB-2640 | Adverse events grade 3-5 | 27 | number of events |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study Cycle 1 (C1) | STARTED | Bevacizumab and TVB-2640 | 13 | |
| Overall Study Cycle 1 (C1) | STARTED | Bevacizumab | 12 | |
| Overall Study Cycle 1 (C1) | COMPLETED | Bevacizumab and TVB-2640 | 12 | |
| Overall Study Cycle 1 (C1) | COMPLETED | Bevacizumab | 12 | |
| Overall Study Cycle 1 (C1) | NOT COMPLETED | Bevacizumab and TVB-2640 | 1 | |
| Overall Study Cycle 1 (C1) | NOT COMPLETED | Bevacizumab | 0 | |
| Start of Second Cycle (C2) | STARTED | Bevacizumab and TVB-2640 | 24 | |
| Start of Second Cycle (C2) | STARTED | Bevacizumab | 0 | |
| Start of Second Cycle (C2) | COMPLETED | Bevacizumab and TVB-2640 | 23 | |
| Start of Second Cycle (C2) | COMPLETED | Bevacizumab | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events39
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 | Palmar plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Bevacizumab and TVB-2640 | 18 | 23 | 41 |
| other | Mucositis | Skin and subcutaneous tissue disorders | Bevacizumab and TVB-2640 | 15 | 23 | 22 |
| other | Hypertension | Cardiac disorders | Bevacizumab and TVB-2640 | 13 | 23 | 21 |
| other | Dry Eye | Eye disorders | Bevacizumab and TVB-2640 | 12 | 23 | 13 |
| other | Fatigue | General disorders | Bevacizumab and TVB-2640 | 7 | 23 | 9 |
| other | Muscle weakness | Musculoskeletal and connective tissue disorders | Bevacizumab and TVB-2640 | 5 | 23 | 5 |
| other | alopecia | Skin and subcutaneous tissue disorders | Bevacizumab and TVB-2640 | 5 | 23 | 5 |
| other | Skin infection | Skin and subcutaneous tissue disorders | Bevacizumab and TVB-2640 | 5 | 23 | 6 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Bevacizumab and TVB-2640 | 4 | 23 | 4 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Bevacizumab and TVB-2640 | 4 | 23 | 4 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab and TVB-2640 | 0 | 23 |
| Total, other adverse events | Bevacizumab and TVB-2640 | 23 | 23 |
| Total, serious adverse events | Bevacizumab and TVB-2640 | 4 | 23 |
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/NCT03032484
GET https://conductscience.org/api/trials/v1/NCT03032484/events?page=2