Trial · NCT03224104
Multi-kinase Inhibitor TG02 (TG02) in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma.
NCT03224104, Phase 1, Completed, European Organisation for Research and Treatment of Cancer - EORTC; results first posted 2025-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Multi-kinase Inhibitor TG02 (TG02) in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma. Trials, record NCT03224104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03224104
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multi-kinase Inhibitor TG02 (TG02) in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma.
- NCT number
- NCT03224104
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 71 participants, actual
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Conditions
- Astrocytoma, Grade III, Glioblastoma
- Interventions
- TG02, Radiation Therapy, Temozolomide
- First posted
- 2017-07-21
- Last updated
- 2025-11-26
- Other registries' IDs
- eudract:2017-001029-42
- Results first posted
- 2025-11-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | From the initiation of TG02 treatment until the determination of the Maximum Tolerated Dose (MTD) for each participant, which is expected to occur within the first 28-day cycle for most participants. | The primary objective in Groups A and B of the EORTC-1608 study is to establish the Maximum Tolerated Dose (MTD) of TG02 and the recommended phase II dose when combined with either radiotherapy (Group A) or temozolomide (Group B) for glioblastoma treatment. The MTD is the highest dose where no more than one of six patients experiences a Dose Limiting Toxicity (DLT). The study requires a 75% dose intensity for TG02 and the concurrent treatment. The trial uses a two-cohort design to assess TG02 with hypofractionated radiotherapy in patients with an unmethylated MGMT promoter or with temozolomide in those with a methylated promoter. Dose escalation begins at 100 mg TG02 twice weekly. If no DLTs occur in the first three patients, the dose increases to 150 mg. If one patient has a DLT, three more are enrolled at the same dose. If no further DLTs occur, escalation continues. If more than one patient has a DLT, escalation stops, and the previous dose is the MTD. |
| Primary | Percentage of Participants Maintaining Progression-free Survival at 6 Months (PFS-6) | The time frame for assessing PFS spans from the date of consent to either disease progression or death. Data are specifically presented for the 6-month time point. | The primary endpoint for Group C is Progression-free survival at 6 months (PFS-6), assessed by Response Assessment in Neuro-Oncology (RANO) criteria. Complete Response (CR) is defined as the disappearance of all enhancing measurable and nonmeasurable disease for at least 4 weeks. Partial Response (PR) requires at least a 50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions for at least 4 weeks. Stable Disease (SD) is when the patient does not qualify for CR, PR, or progression, with stable nonenhancing lesions on the same or lower dose of corticosteroids. Progression (PD) is defined as at least a 25% increase in the sum of products of perpendicular diameters of enhancing lesions compared to the smallest measurement at baseline or best response, a significant increase in T2/FLAIR lesion, any new lesion, or clear clinical deterioration not attributable to other causes. |
| Secondary | Progression-free Survival | The time frame for assessing PFS is the duration from the date of consent until disease progression or death. PFS was assessed by its median the point time at which 50% of the patients have experienced death. | Progression-free survival (PFS) is a secondary endpoint for Group C. PFS is defined as the number of days from consent to the date of earliest disease progression based on Response Assessment in Neuro Oncology (RANO) criteria (as determined by the Investigator) or to the date of death, if disease progression does not occur. For all groups, the median PFS will be determined. PFS is measured from the start of treatment until the date of disease progression or death, whichever occurs first. Patients without progression or death will be censored at the last date documented to be alive and progression-free. |
| Secondary | Overall Survival (OS) | The time frame for assessing OS is from consent to the date until death or the end of the study, whichever comes first. OS was assessed by its median the point time at which 50% of the patients have experienced death. | Overall Survival (OS) is a secondary endpoint for Group C. OS is defined as the number of days from consent to the date of death due to any cause. If a patient has not died, the data was censored at the last date documented to be alive. For all groups, the median OS was determined. The median OS was extracted from the Kaplan-Meier OS curve, |
| Secondary | Objective Response | Time frame for assessing response is from the initiation of treatment with TG02 until disease progression or death. It was not assessed at specific time point but throughout the study. The OR rate is determined based on the best response observed. | Objective Response (OR) is a secondary endpoint for Group C. For patients with measurable disease after debulking or non-surgical patients with measurable disease after surgery for recurrence, the best overall response distribution (BOR), objective response rate (PR+CR), complete response rate, and duration of response (DOR) was assessed. The objective response rate is the proportion of patients who achieve a partial response (PR) or complete response (CR), while the complete response rate is the proportion of patients who achieve a CR. The duration of response (DOR) is the time from the first documented response (PR or CR) to the date of disease progression or death, whichever occurs first. |
| Secondary | Neurological Progression-free Survival | The time frame for assessing NPFS spans from the date of consent to either disease progression or death.NPFS was assessed by its median the point time at which 50% of the patients have experienced death. | Neurological progression-free survival (NPFS) is a secondary endpoint for Group C. NPFS is defined based on the Neurologic Assessment in Neuro-Oncology (NANO) criteria. NPFS is measured from the date of enrollment in the trial until the date of first neurological progression or death, whichever occurs first. If a patient does not experience neurological progression or death, the data will be censored at the last date of post-baseline neurological assessment. The median NPFS will be determined. |
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 | Maximum Tolerated Dose (MTD) | From the initiation of TG02 treatment until the determination of the Maximum Tolerated Dose (MTD) for each participant, which is expected to occur within the first 28-day cycle for most participants. | Group A - TG02 + radiotherapy (RT) is combining patients from Group A - TG02 + Radiotherapy (RT) Dose 1 who received TG02 at 100 mg and patients from Group A - TG02 + Radiotherapy (RT) Dose 2 who received TG02 at 150 mg.Similarly, Group B - TG02 + TMZ is combining patient from Group B - TG02 + Temozolomide (TMZ) Dose 1 100 mg who received TG02 at 100 mg and patients from Group B - TG02 + Temozolomide (TMZ) Dose 2 who received TG02 at 150 mg. | mg | NUMBER |
| PRIMARY | Percentage of Participants Maintaining Progression-free Survival at 6 Months (PFS-6) | The time frame for assessing PFS spans from the date of consent to either disease progression or death. Data are specifically presented for the 6-month time point. | Analyses are performed in the first 45 patients included in the efficacy population defined as all patients who are eligible and have started their allocated treatment. Due to small sample size, in Group A , we combined patients who received either the initial 100 mg dose or the escalated 150 mg dose and in Group B,we combined patients treated at both the starting dose of 100 mg and the increased dose of 150 mg.In group C we included patients who received the initial dose of 150 mg. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival | The time frame for assessing PFS is the duration from the date of consent until disease progression or death. PFS was assessed by its median the point time at which 50% of the patients have experienced death. | Analyses are performed in the efficacy population defined as all patients who are eligible and have started their allocated treatment. In Group A patients received either the initial 100 mg dose or the escalated 150 mg dose and in Group B, patients received the starting dose of 100 mg and the increased dose of 150 mg.In group C we included patients who received the initial dose of 150 mg. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | The time frame for assessing OS is from consent to the date until death or the end of the study, whichever comes first. OS was assessed by its median the point time at which 50% of the patients have experienced death. | The intent-to-treat (ITT) population was used which is defined as all enrolled patients who will be analyzed in the arm they were allocated by randomization. In Group A patients received either the initial 100 mg dose or the escalated 150 mg dose and in Group B, patients received the starting dose of 100 mg and the increased dose of 150 mg.In group C we included patients who received the initial dose of 150 mg. | Months | MEDIAN |
| SECONDARY | Objective Response | Time frame for assessing response is from the initiation of treatment with TG02 until disease progression or death. It was not assessed at specific time point but throughout the study. The OR rate is determined based on the best response observed. | Analysis population is the intent-to-treat (ITT) population defined as all enrolled patients who will be analyzed in the arm they were allocated by randomization. In Group A patients received either the initial 100 mg dose or the escalated 150 mg dose and in Group B, patients received the starting dose of 100 mg and the increased dose of 150 mg.In group C we included patients who received the initial dose of 150 mg. | Number of participants | NUMBER |
| SECONDARY | Neurological Progression-free Survival | The time frame for assessing NPFS spans from the date of consent to either disease progression or death.NPFS was assessed by its median the point time at which 50% of the patients have experienced death. | Analyses are performed in the efficacy population defined as all patients who are eligible and have started their allocated treatment (at least one study drug dose). In Group A patients received either the initial 100 mg dose or the escalated 150 mg dose and in Group B, patients received the starting dose of 100 mg and the increased dose of 150 mg.In group C we included patients who received the initial dose of 150 mg. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) | Group A - TG02 + Radiotherapy (RT) | 150 | mg | ||
| Maximum Tolerated Dose (MTD) | Group B - TG02 + Temozolomide (TMZ) | 150 | mg | ||
| Percentage of Participants Maintaining Progression-free Survival at 6 Months (PFS-6) | Group C - TG02 | 6.7 | 80% Confidence Interval 2.5 to 14.3 | percentage of participants | |
| Progression-free Survival | Group A - TG02 + RT - 100 mg | 2.4 | 95% Confidence Interval 1.8 to 2.4 | Months | |
| Progression-free Survival | Group A - TG02 + RT - 150 mg | 4.4 | 95% Confidence Interval 1.4 to 6.7 | Months | |
| Progression-free Survival | Group B - TG02 + TMZ - 100 mg | 4.9 | 95% Confidence Interval 2.6 to 4.9 | Months | |
| Progression-free Survival | Group B - TG02 + TMZ - 150 mg | 7.1 | 95% Confidence Interval 4.6 to 7.1 | Months | |
| Progression-free Survival | Group C - TG02 | 1.87 | 95% Confidence Interval 1.64 to 1.94 | Months | |
| Overall Survival (OS) | Group A - TG02 + RT - 100 mg | 9.3 | 95% Confidence Interval 1.8 to 9.3 | Months | |
| Overall Survival (OS) | Group A - TG02 + RT - 150 mg | 6.7 | 95% Confidence Interval 4.4 to 6.7 | Months |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A - TG02 + Radiotherapy (RT) Dose 1 100 mg | 3 | |
| Overall Study | STARTED | Group A - TG02 + Radiotherapy (RT) Dose 2 150 mg | 9 | |
| Overall Study | STARTED | Group B - TG02 + Temozolomide (TMZ) Dose 1 100 mg | 3 | |
| Overall Study | STARTED | Group B - TG02 + Temozolomide (TMZ) Dose 2 150 mg | 6 | |
| Overall Study | STARTED | Group C - TG02 | 50 | |
| Overall Study | COMPLETED | Group A - TG02 + Radiotherapy (RT) Dose 1 100 mg | 0 | |
| Overall Study | COMPLETED | Group A - TG02 + Radiotherapy (RT) Dose 2 150 mg | 0 | |
| Overall Study | COMPLETED | Group B - TG02 + Temozolomide (TMZ) Dose 1 100 mg | 0 | |
| Overall Study | COMPLETED | Group B - TG02 + Temozolomide (TMZ) Dose 2 150 mg | 0 | |
| Overall Study | COMPLETED | Group C - TG02 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events930
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 | Group A - TG02 + RT - 100 mg | 0 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Group A - TG02 + RT - 150 mg | 0 | 9 | |
| other | Anemia | Blood and lymphatic system disorders | Group B - TG02 + TMZ - 100 mg | 0 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Group B - TG02 + TMZ - 150 mg | 1 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Group C - TG02 | 0 | 50 | |
| other | Palpitations | Cardiac disorders | Group A - TG02 + RT - 100 mg | 0 | 3 | |
| other | Palpitations | Cardiac disorders | Group A - TG02 + RT - 150 mg | 1 | 9 | |
| other | Palpitations | Cardiac disorders | Group B - TG02 + TMZ - 100 mg | 0 | 3 | |
| other | Palpitations | Cardiac disorders | Group B - TG02 + TMZ - 150 mg | 0 | 6 | |
| other | Palpitations | Cardiac disorders | Group C - TG02 | 0 | 50 |
1 to 10 of 930Source ClinicalTrials.gov
See all 930 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A - TG02 + RT - 100 mg | 3 | 3 |
| Total, all-cause mortality | Group A - TG02 + RT - 150 mg | 7 | 9 |
| Total, all-cause mortality | Group B - TG02 + TMZ - 100 mg | 3 | 3 |
| Total, all-cause mortality | Group B - TG02 + TMZ - 150 mg | 3 | 6 |
| Total, all-cause mortality | Group C - TG02 | 42 | 50 |
| Total, other adverse events | Group A - TG02 + RT - 100 mg | 3 | 3 |
| Total, other adverse events | Group A - TG02 + RT - 150 mg | 9 | 9 |
| Total, other adverse events | Group B - TG02 + TMZ - 100 mg | 3 | 3 |
| Total, other adverse events | Group B - TG02 + TMZ - 150 mg | 6 | 6 |
| Total, other adverse events | Group C - TG02 | 46 | 50 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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/NCT03224104
GET https://conductscience.org/api/trials/v1/NCT03224104/results?page=2