Trial · NCT02067156
Efficacy, Safety and CNS Exposure of G-202 (Mipsagargin) in Patients With Recurrent or Progressive Glioblastoma
NCT02067156, Phase 2, Completed, GenSpera, Inc.; results first posted 2024-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety and CNS Exposure of G-202 (Mipsagargin) in Patients With Recurrent or Progressive Glioblastoma. Trials, record NCT02067156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02067156
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and CNS Exposure of G-202 (Mipsagargin) in Patients With Recurrent or Progressive Glioblastoma
- NCT number
- NCT02067156
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- GenSpera, Inc.
- Conditions
- Glioblastoma Multiforme
- Interventions
- G-202
- First posted
- 2014-02-20
- Last updated
- 2024-05-21
- Results first posted
- 2024-05-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6-month Progression-free Survival (PFS) | 6 months | Percentage of patients who received at least 2 cycles of G-202 and have not progressed or died within 6 months of beginning treatment with G-202. Progression is defined using Response Assessment in Neuro-Oncology Working Group (RANO) for high-grade glioma, as any of the following: by any of the following: 25% or greater increase in sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of nonmeasurable lesions; or definite clinical deterioration not attributable to other causes apart from the tumor, or to decrease in corticosteroid dose. |
| Secondary | Toxicity Assessed by CTCAE v 4.03 Criteria | Every 2 weeks for approximately one year | Percentage of all analyzed patients experiencing treatment-emergent adverse events. |
| Secondary | Objective Tumor Response Rate | approximately one year | Percentage of analyzed participants experiencing a complete response (CR) or partial response (PR) using RANO criteria. CR is defined as complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions; and patient must be off corticosteroids or on physiologic replacement doses only, and stable or improved clinically. PR is defined as at least 50% decrease, compared with baseline, in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no progression of nonmeasurable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and patient must be on a corticosteroid dose not greater than the dose at time of baseline scan and is stable or improved clinically. |
| Secondary | Duration of PFS | Every 4 weeks for approximately one year | Duration of time from the first administration of G-202 until the first documented progression or date of death, assessed up to 12 months. Progression is defined using Response Assessment in Neuro-Oncology Working Group (RANO) for high-grade glioma, as any of the following: by any of the following: 25% or greater increase in sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of nonmeasurable lesions; or definite clinical deterioration not attributable to other causes apart from the tumor, or to decrease in corticosteroid dose. |
| Secondary | Overall Survival | Every 4 weeks for approximately one year | Duration of time from the first administration of G-202 until the date of death, assessed up to 12 months |
| Secondary | Biomarkers in Tumor | Within 4 weeks of receiving G-202 | PSMA immunohistochemistry staining score on tumor tissue collected prior to start of G-202 study treatment. Intensity of staining was ranked on a scale of 0, 1, 2, or 3 (with 0 representing no staining and 3 representing maximum intensity): absence of staining (0), weak staining (1), medium staining (2), or strong staining (3) relative to a staining calibration curve and normalized to the image mean background intensity. The scoring scale does not have a title nor does it have a subscale. It is not known whether PSMA staining intensity is associated with tumor molecular phenotypes or response outcome to G-202; therefore, this was an exploratory analysis. However, the lack of objective tumor response in the trial precluded comparative analysis. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6-month Progression-free Survival (PFS) | 6 months | response-evaluable participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Toxicity Assessed by CTCAE v 4.03 Criteria | Every 2 weeks for approximately one year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Tumor Response Rate | approximately one year | response-evaluable participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of PFS | Every 4 weeks for approximately one year | response-evaluable participants | months | MEDIAN |
| SECONDARY | Overall Survival | Every 4 weeks for approximately one year | response-evaluable participants | months | MEDIAN |
| SECONDARY | Biomarkers in Tumor | Within 4 weeks of receiving G-202 | Only 11 samples of tumor tissue collected prior to the start of study treatment (G-202) were available for immunohistochemistry. PSMA staining was not an eligibility criterion. | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6-month Progression-free Survival (PFS) | G-202 (Mipsagargin) | 1 | Participants | ||
| Toxicity Assessed by CTCAE v 4.03 Criteria | G-202 (Mipsagargin) | 26 | Participants | ||
| Objective Tumor Response Rate | G-202 (Mipsagargin) | 0 | Participants | ||
| Duration of PFS | G-202 (Mipsagargin) | 1.64 | 95% Confidence Interval 1.05 to 1.74 | months | |
| Overall Survival | G-202 (Mipsagargin) | 7.23 | 95% Confidence Interval 6.08 to 17 | months | |
| Biomarkers in Tumor | G-202 (Mipsagargin) | 2 | Standard Deviation 1.1 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | G-202 (Mipsagargin) | 26 | |
| Overall Study | COMPLETED | G-202 (Mipsagargin) | 22 | |
| Overall Study | NOT COMPLETED | G-202 (Mipsagargin) | 4 |
Source ClinicalTrials.gov
Adverse events32
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 | G-202 (Mipsagargin) | 5 | 26 | |
| other | Constipation | Gastrointestinal disorders | G-202 (Mipsagargin) | 2 | 26 | 2 |
| other | Nausea | Gastrointestinal disorders | G-202 (Mipsagargin) | 6 | 26 | 6 |
| other | Vomiting | Gastrointestinal disorders | G-202 (Mipsagargin) | 5 | 26 | 5 |
| other | Fatigue | General disorders | G-202 (Mipsagargin) | 3 | 26 | 3 |
| other | Fever | General disorders | G-202 (Mipsagargin) | 2 | 26 | 2 |
| other | ALT increased | Investigations | G-202 (Mipsagargin) | 9 | 26 | 11 |
| other | AST increased | Investigations | G-202 (Mipsagargin) | 6 | 26 | 6 |
| other | Creatinine increased | Investigations | G-202 (Mipsagargin) | 11 | 26 | 18 |
| other | Platelet count decreased | Investigations | G-202 (Mipsagargin) | 7 | 26 | 9 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | G-202 (Mipsagargin) | 22 | 26 |
| Total, other adverse events | G-202 (Mipsagargin) | 24 | 26 |
| Total, serious adverse events | G-202 (Mipsagargin) | 6 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD005077 | Phase 2 Study of Vascular-Targeted Prodrug (G-202) for the Treatment of Recurrent Glioblastoma | KESARI, SANTOSH; ZANETTI, MAURIZIO | SAINT JOHN'S CANCER INSTITUTE | FOOD AND DRUG ADMINISTRATION | 2015 to 2017 |
Source NIH RePORTER
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/NCT02067156
GET https://conductscience.org/api/trials/v1/NCT02067156/events?page=2