Trial · NCT02655601
Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001
NCT02655601, Phase 1, Phase 2, Completed, BioMimetix JV, LLC; results first posted 2025-06-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001. Trials, record NCT02655601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02655601
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001
- NCT number
- NCT02655601
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 177 participants, actual
- Lead sponsor
- BioMimetix JV, LLC
- Conditions
- High Grade Glioma, Astrocytoma, Grade III, Glioblastoma
- Interventions
- BMX-001, Radiation Therapy, Temozolomide
- First posted
- 2016-01-14
- Last updated
- 2025-06-08
- Results first posted
- 2025-06-08
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Maximum Tolerated Dose (MTD) of BMX-001 Administered in Combination With Standard RT and TMZ in Newly Diagnosed HGG Patients | From the time the subject signs the informed consent form through 30 days after completion of the final BMX-001 treatment (up to approximately 16 weeks) | This was a dose escalation study in which patients were enrolled to receive 1 of 4 doses in dose ascending order. MTD was defined as the dose level that has an estimated DLT rate nearest to 0.25. This is applicable to the Phase 1 part of the study only. Note that an actual MTD was not reached, however a Phase 2 recommended dose was selected based on the dose that was most tolerable to patients. |
| Primary | Phase 2: Overall Survival, Intent to Treat (ITT) Population | From the time between randomization and death, or the date of last follow-up if the patient remains alive. Per protocol, patients will be followed indefinitely | This is applicable for Phase 2 only. It was a secondary objective of Phase 1 and that is reported as a separate outcome measure. Assessment of overall survival. With standard treatment, the median survival of Grade IV patients is expected to be 14.6 months, and the median survival of Grade III is approximately 36 months. Given that we anticipate that approximately 10% of patients to be Grade III, we estimate that the overall median survival with standard treatment to be roughly 16.7 months. |
| Secondary | Phase 1: Median Overall Survival | From the time between enrollment and death, or the date of last follow-up if the patient remains alive. | Median Overall Survival (OS) is a key clinical outcome measure used to assess the efficacy of BMX-001 in combination with standard radiotherapy (RT) and temozolomide (TMZ) in patients with newly diagnosed high-grade gliomas (HGG). OS is defined as the time from the date of study enrollment to the date of death from any cause. Survival status was assessed at regular follow-up intervals (e.g., every 3 months post-treatment) through medical records, patient contact, and clinical evaluations. The final analysis was conducted after a pre-specified number of events (deaths) have occurred. Expected Outcome: Prolonged median OS compared to historical or control data (RT + TMZ alone) would suggest a survival benefit associated with BMX-001. |
| Secondary | Phase 1: Number of Participants Who Experiences a Dose-limiting Toxicity (DLT). | From the time the subject signs the informed consent form through 30 days after completion of the final BMX-001 treatment (up to approximately 16 weeks) | This is only applicable for the Phase 1 portion of the study. All patients who received at least 1 dose of BMX-001, regardless of dose level, after enrolling on study are included in the analysis. |
| Secondary | Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Adjusted Change T Score Achieved on the Controlled Oral Word Association Test (COWAT). | From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks) | The Controlled Oral Word Association Test (COWAT) measures verbal fluency which reflects executive functioning, processing speed, mental flexibility, and language output. The raw score is then adjusted for age, education, and normative data to allow meaningful comparisons across individuals. The standardized score (T-score) is calculated using normative reference tables. Higher Scores = Better Cognitive Function, lower scores = cognitive impairment. T score range is 0-100. A T-score of 50 represents the mean performance in the normative population, this means a score of 50 indicates the population mean performance with a standard deviation of 10. T-scores below 40 suggest clinically significant cognitive decline. Scores range from \< 30 (significantly below average), to 30-39 (below average), 40-59 (average), and greater than or equal to 60 is above average. Stable or improved COWAT scores over time would suggest that adding BMX-001 may help preserve cognitive function. |
| Secondary | Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trails Making Test (TMT): Part A | From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks) | Part A of the Trails Making Test (TMT) measures visual attention and processing speed by requiring the patient to connect numbers sequentially (1 → 2 → 3, etc.) as quickly as possible. This is a widely used neuropsychological test that measures visual attention, processing speed, and psychomotor function. Raw scores are measured in seconds (time to complete the task), but T-scores are derived by converting time-based results into a normed distribution accounting for age and education. Mean (SD) change in cognitive assessment in T-Scores is reported and the range is 0-100. T score interpretation and range is \< 30 (significantly impaired), 30-39 (mildly impaired), 40-59 (Average), \>/= 60 (Above average). A T-score of 50 represents the mean performance in the normative population, this means a score of 50 indicates the population mean performance with a standard deviation of 10. Higher scores = better performance. |
| Secondary | Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trail Making Test (TMT): Part B | From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks) | The Trails Making Test (TMT) Part B is a widely used neuropsychological test that measures set-shifting ability, processing speed, and working memory. While Part A focuses on speed, visual scanning, and attention. Prolonged completion time or an increase in errors compared to baseline or age-adjusted norms would indicate cognitive decline. Raw scores are measured in seconds (time to complete the task), but T-scores are derived by converting time-based results into a normed distribution accounting for age and education. Mean (SD) change in T score is reported, range is 0-100. T score interpretation and range is \< 30 (significantly impaired), 30-39 (mildly impaired), 40-59 (Average), \>/= 60 (Above average). A T-score of 50 represents the mean performance in the normative population, this means a score of 50 indicates the population mean performance with a standard deviation of 10. Higher scores = better performance. |
| Secondary | Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Total Recall Change T-score Achieved on the Hopkins Verbal Learning Test- Revised (HVLT-R) | From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks) | Hopkins Verbal Learning Test- Revised (HVLT-R) is a standardized neuropsychological assessment that measures verbal learning and memory, including total (immediate recall). Total Recall T-score is derived from the sum of correctly recalled words across three learning trials and is normalized based on age-adjusted normative data. This provides insight into immediate verbal memory performance and learning ability. Total Recall (Immediate Memory \& Learning) is Sum of correctly recalled words across three learning trials and is a measurement of immediate recall capacity and learning efficiency. Raw score range is 0-36, T score range is 0-100. T scores \>/= 60 are above average and T scores \< 40 are below average. A T-score of 50 represents the mean performance in the normative population, this means a score of 50 indicates the population mean with a standard deviation of 10 |
| Secondary | Phase 2: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Adverse events occurring from baseline through 30 days post completion of treatment (approximately 12 weeks total). | To assess the safety and tolerability of standard RT and TMZ in combination with BMX-001 compared to standard RT and TMZ alone in newly diagnosed HGG patients. The phase 2 portion of this study has two adverse event endpoints: 1. The proportion of patients who experience any grade 3 or 4 adverse event during radiation and temozolomide treatment, and 2. The proportion of patients who experience a grade 3 or 4 adverse event that is definitely, possibly, or probably related to BMX-001 treatment during this same period. This outcome measure does not apply to the Phase 1 portion of the study, as it was not designated as an outcome for Phase 1 but was specified only for Phase 2. |
| Secondary | Phase 2: Incidence of Treatment-Emergent Adverse Events Related to BMX-001 | Adverse events occurring from baseline through 30 days post completion of treatment (approximately 12 weeks total). | To assess the safety and tolerability of standard RT and TMZ in combination with BMX-001 compared to standard RT and TMZ alone in newly diagnosed HGG patients. This outcome is measured to test the proportion of patients who experience a grade 3 or 4 adverse event that is definitely, possibly, or probably related to BMX-001 treatment during this same period. This outcome measure does not apply to the Phase 1 portion of the study, as it was not designated as an outcome for Phase 1 but was specified only for Phase 2. It also only applies to Arm A in the study as Arm B did not receive the study drug. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Maximum Tolerated Dose (MTD) of BMX-001 Administered in Combination With Standard RT and TMZ in Newly Diagnosed HGG Patients | From the time the subject signs the informed consent form through 30 days after completion of the final BMX-001 treatment (up to approximately 16 weeks) | All patients who received at least 1 dose of BMX-001, regardless of dose level, after enrolling on study. | mg/Participant | NUMBER |
| PRIMARY | Phase 2: Overall Survival, Intent to Treat (ITT) Population | From the time between randomization and death, or the date of last follow-up if the patient remains alive. Per protocol, patients will be followed indefinitely | All enrolled participants enrolled in Phase 2 were included in the analysis. This was not a primary objective of Phase 1. | months | MEDIAN |
| SECONDARY | Phase 1: Median Overall Survival | From the time between enrollment and death, or the date of last follow-up if the patient remains alive. | This analysis includes all participants enrolled. A Kaplan-Meier analysis is not appropriate for very small groups in each dose escalation cohort because the statistical power would be insufficient, leading to unreliable survival estimates. According to the study statistical analysis plan, OS will be assessed for all participants enrolled in Phase 1 as a whole, rather than separately by dose level. | Months | MEDIAN |
| SECONDARY | Phase 1: Number of Participants Who Experiences a Dose-limiting Toxicity (DLT). | From the time the subject signs the informed consent form through 30 days after completion of the final BMX-001 treatment (up to approximately 16 weeks) | All patients who received at least 1 dose of BMX-001, regardless of dose level, after enrolling on study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Adjusted Change T Score Achieved on the Controlled Oral Word Association Test (COWAT). | From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks) | Only 6 out of 17 eligible participants completed COWAT assessments at the time this objective was measured 24 weeks after the end of standard of care Radiotherapy + Temozolomide. | T-score | MEAN |
| SECONDARY | Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trails Making Test (TMT): Part A | From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks) | Only 6 out of 17 eligible participants completed Trail Making Test (TMT): Part A assessments at the time this objective was measured 24 weeks after the end of standard of care Radiotherapy + Temozolomide. | T-Score | MEAN |
| SECONDARY | Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Score Achieved on the Trail Making Test (TMT): Part B | From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks) | Only 6 out of 17 eligible participants completed Trail Making Test (TMT): Part B assessments at the time this objective was measured 24 weeks after the end of standard of care Radiotherapy + Temozolomide. | T-score | MEAN |
| SECONDARY | Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Normalized Total Recall Change T-score Achieved on the Hopkins Verbal Learning Test- Revised (HVLT-R) | From the time the subject signs the informed consent form through 6 months after completion of the final BMX-001 treatment (up to approximately 40 weeks) | Only 6 out of 17 eligible participants completed HVLT-R assessments at the time this objective was measured 24 weeks after the end of standard of care Radiotherapy + Temozolomide. | T-Score | MEAN |
| SECONDARY | Phase 2: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Adverse events occurring from baseline through 30 days post completion of treatment (approximately 12 weeks total). | This analysis focuses on the proportion of patients who experience any grade 3 or 4 adverse event during radiation and temozolomide treatment.~This outcome measure does not apply to the Phase 1 portion of the study, as it was not designated as an outcome for Phase 1 but was specified only for Phase 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Incidence of Treatment-Emergent Adverse Events Related to BMX-001 | Adverse events occurring from baseline through 30 days post completion of treatment (approximately 12 weeks total). | This outcome measure does not apply to the Phase 1 portion of the study, as it was not designated as an outcome for Phase 1 but was specified only for Phase 2.~This analysis focuses on the proportion of patients who experience a grade 3 or 4 adverse event that is definitely, possibly, or probably related to BMX-001 treatment during this same period. Data is only presented for Arm A, the BMX-001 treatment group, as subjects in Arm B did not receive BMX-001. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Maximum Tolerated Dose (MTD) of BMX-001 Administered in Combination With Standard RT and TMZ in Newly Diagnosed HGG Patients | Phase 1 | NA | mg/Participant | ||
| Phase 2: Overall Survival, Intent to Treat (ITT) Population | Arm A: Ph 2 Radiation Therapy, TMZ and BMX-001 | 32.2 | 95% Confidence Interval 21.8 to NA | months | |
| Phase 2: Overall Survival, Intent to Treat (ITT) Population | ARm B: Ph 2 Radiation Therapy and TMZ | 27.6 | 95% Confidence Interval 19.8 to 33.8 | months | |
| Phase 1: Median Overall Survival | Phase 1 | 22.2 | 95% Confidence Interval 11.2 to 24.7 | Months | |
| Phase 1: Number of Participants Who Experiences a Dose-limiting Toxicity (DLT). | Phase 1 | BMX-001: 42 mg loading dose / 20 mg biw dose | 1 | Participants | |
| Phase 1: Number of Participants Who Experiences a Dose-limiting Toxicity (DLT). | Phase 1 | BMX-001: 28 mg loading dose / 14 mg biw dose | 0 | Participants | |
| Phase 1: Number of Participants Who Experiences a Dose-limiting Toxicity (DLT). | Phase 1 | BMX-001: 14 mg loading dose / 7 mg biw dose | 0 | Participants | |
| Phase 1: Number of Participants Who Experiences a Dose-limiting Toxicity (DLT). | Phase 1 | BMX-001: 7 mg loading dose / 3.5 mg biw dose | 0 | Participants | |
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Adjusted Change T Score Achieved on the Controlled Oral Word Association Test (COWAT). | Phase 1 | BMX-001: 7 mg loading dose / 3.5 mg biw dose | 4 | Standard Deviation NA | T-score |
Phase 1: Examine the Impact on Cognition of BMX-001 in Combination With Standard RT and TMZ in Treatment of Newly Diagnosed HGG Patients Via the Adjusted Change T Score Achieved on the Controlled Oral Word Association Test (COWAT). | Phase 1 | BMX-001: 14 mg loading dose / 7 mg biw dose | -3 | Standard Deviation NA | T-score |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1 BMX-001 7 mg Loading Dose/3.5 mg Biw Dose | 4 | |
| Overall Study | STARTED | Phase 1 BMX-001 14 mg Loading Dose/7 mg Biw Dose | 3 | |
| Overall Study | STARTED | Phase 1 BMX-001 28 mg Loading Dose/14 mg Biw Dose | 6 | |
| Overall Study | STARTED | Phase 1 BMX-001 42 mg Loading Dose/20 mg Biw Dose | 4 | |
| Overall Study | STARTED | Ph 2 Radiation Therapy, TMZ and BMX-001 | 80 | |
| Overall Study | STARTED | Ph 2 Radiation Therapy and TMZ | 80 | |
| Overall Study | COMPLETED | Phase 1 BMX-001 7 mg Loading Dose/3.5 mg Biw Dose | 3 | |
| Overall Study | COMPLETED | Phase 1 BMX-001 14 mg Loading Dose/7 mg Biw Dose | 3 | |
| Overall Study | COMPLETED | Phase 1 BMX-001 28 mg Loading Dose/14 mg Biw Dose | 6 | |
| Overall Study | COMPLETED | Phase 1 BMX-001 42 mg Loading Dose/20 mg Biw Dose | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events2,076
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 | Anaemia | Blood and lymphatic system disorders | Phase 1: BMX-001: 7 mg Loading Dose / 3.5 mg Biw Dose | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: BMX-001: 14 mg Loading Dose / 7 mg Biw Dose | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: BMX-001: 28 mg Loading Dose / 14 mg Biw Dose | 5 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: BMX-001: 42 mg Loading Dose / 20 mg Biw Dose | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A: Radiation Therapy, TMZ and BMX-001 | 22 | 80 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Radiation Therapy and TMZ | 14 | 80 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Phase 1: BMX-001: 7 mg Loading Dose / 3.5 mg Biw Dose | 0 | 4 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Phase 1: BMX-001: 14 mg Loading Dose / 7 mg Biw Dose | 0 | 3 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Phase 1: BMX-001: 28 mg Loading Dose / 14 mg Biw Dose | 0 | 6 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Phase 1: BMX-001: 42 mg Loading Dose / 20 mg Biw Dose | 0 | 4 |
1 to 10 of 2,076Source ClinicalTrials.gov
See all 2,076 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: BMX-001: 7 mg Loading Dose / 3.5 mg Biw Dose | 3 | 4 |
| Total, all-cause mortality | Phase 1: BMX-001: 14 mg Loading Dose / 7 mg Biw Dose | 3 | 3 |
| Total, all-cause mortality | Phase 1: BMX-001: 28 mg Loading Dose / 14 mg Biw Dose | 6 | 6 |
| Total, all-cause mortality | Phase 1: BMX-001: 42 mg Loading Dose / 20 mg Biw Dose | 4 | 4 |
| Total, all-cause mortality | Arm A: Radiation Therapy, TMZ and BMX-001 | 41 | 80 |
| Total, all-cause mortality | Arm B: Radiation Therapy and TMZ | 48 | 80 |
| Total, other adverse events | Phase 1: BMX-001: 7 mg Loading Dose / 3.5 mg Biw Dose | 4 | 4 |
| Total, other adverse events | Phase 1: BMX-001: 14 mg Loading Dose / 7 mg Biw Dose | 3 | 3 |
| Total, other adverse events | Phase 1: BMX-001: 28 mg Loading Dose / 14 mg Biw Dose | 6 | 6 |
| Total, other adverse events | Phase 1: BMX-001: 42 mg Loading Dose / 20 mg Biw Dose | 4 | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers4
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Ph 2 Radiation Therapy, TMZ and BMX-001 vs Arm B: Ph 2 Radiation Therapy and TMZ: Phase 2: Protection of Bone Marrow Against Chemotherapy-Induced Thrombocytopenia | Trial comparisons |
| Arm A: Ph 2 Radiation Therapy, TMZ and BMX-001 vs Arm B: Ph 2 Radiation Therapy and TMZ: Phase 2: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Trial comparisons |
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
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.
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GET https://conductscience.org/api/trials/v1/NCT02655601/results?page=2