Trial · NCT00761280
Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma
NCT00761280, Phase 3, Terminated, Isarna Therapeutics GmbH; results first posted 2014-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma. Trials, record NCT00761280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00761280
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma
- NCT number
- NCT00761280
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 27 participants, actual
- Lead sponsor
- Isarna Therapeutics GmbH
- Conditions
- Anaplastic Astrocytoma, Glioblastoma
- Interventions
- trabedersen, temozolomide, Drug delivery system for administration of AP 12009, Placement of Drug Delivery System, carmustine, lomustine
- First posted
- 2008-09-29
- Last updated
- 2014-11-14
- Results first posted
- 2014-08-22
- Limitations and caveats
Early termination of the study leading to recruitment of 27 of 180 planned subjects and incomplete collection of data. Survival results are based on post-study collection of additional survival data under a protocol amendment.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | 24 months | Survival rate was defined as the proportion of participants known to be alive at 24 months from randomization. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis. |
| Primary | Survival at 24 Months in the Intent-to-treat Population - Number of Participants | 24 months | Survival status was assessed at 24 months from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category "Lost to / insufficient follow-up" includes participants who were alive at last data collection point but did not yet have enough follow-up time to reach the 24 month time point. |
| Secondary | Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | 12, 18, and 21 months | Survival rate was defined as the proportion of participants known to be alive at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. |
| Secondary | Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants | 12, 18, and 21 months | Survival status was assessed at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category "Lost to follow-up" for each time-point includes participants who were alive at the last data collection point but did not yet have enough follow-up time to reach the time point. |
| Secondary | Median Overall Survival (Days) From Randomization in the Intent-to-treat Population (Descriptive Analysis, Only) | Up to 24 months | Median overall survival was defined as the date of randomization to the date of death. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis. Analysis was by Kaplan-Meier estimation. |
| Secondary | Response Category by Independent Review in the Intent-to-treat Population - Number of Participants | Up to 24 months | Tumor response was classified based on the (neuro-)radiologist's evaluation according to the Macdonald Response Criteria for bidimensionally measurable disease as outlined below: * Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved. * Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved. * Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse. * Stable Disease (SD): all other situations. Two qualified neuro-radiologists reviewed scans at each MRI time point, with adjudication of discrepancies by a third reviewer. Their findings and clinical information were independently reviewed by a neuro-oncologist, who made the assessment of overall response. |
| Secondary | Overall Response Rate (CR+PR) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Up to 24 months | Overall response rate was the proportion of participants with a best response of Complete Response (CR) or Partial Response (PR) observed from the start of treatment until disease progression. |
| Secondary | Tumor Control Rate (CR+PR+SD) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Up to 24 months | Tumor control rate was defined as the proportion of participants assessed as having Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Participants with unknown or missing response were treated as non-responders. |
| Secondary | Median Duration of Response (Days) by Independent Review (Descriptive Analysis, Only) | Up to 24 months | Duration of response was defined as the time from the first documentation of confirmed response (Complete Response, CR, or Partial Response, PR) to the first signs of Progressive Disease (PD), as assessed by the study neuro-oncologist. Median Duration of Response was calculated by Kaplan-Meier estimate. Censoring rules were: * at the date of randomization -- participants without baseline assessments, or for those with no post-baseline timor assessments who were discontinued for other than progressive disease or death. * at the date of last tumor assessment -- discontinuation other than PD or death, or if a new treatment was started prior to disease progression * at the date of death or last tumor assessment -- death or PD after one missed tumor assessment * at the date of last tumor assessment -- death or PD after more than one missed tumor assessment * at the date of last tumor assessment -- participants on ongoing treatment at data cut-off |
| Secondary | Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants | 10, 12, 14, 16, 18, 21, and 24 months | Tumor response was classified based on the (neuro-)radiologist's evaluation: * Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved. * Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved. * Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse. * Stable Disease (SD): all other situations. Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of "Progressed" versus "Not Progressed". Participants who had MRI assessment results missing or unknown were "UNK or missing", and were treated as "Progressed" for the purposes of the calculation. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | 24 months | The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented. | percentage of participants | NUMBER |
| SECONDARY | Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | 12, 18, and 21 months | The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented. | percentage of participants | NUMBER |
| SECONDARY | Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants | 12, 18, and 21 months | The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented. | participants | NUMBER |
| SECONDARY | Median Overall Survival (Days) From Randomization in the Intent-to-treat Population (Descriptive Analysis, Only) | Up to 24 months | The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented. | days | MEDIAN |
| SECONDARY | Response Category by Independent Review in the Intent-to-treat Population - Number of Participants | Up to 24 months | The Intent-to-treat population includes all participants randomized. | participants | NUMBER |
| SECONDARY | Overall Response Rate (CR+PR) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Up to 24 months | The Intent-to-treat population includes all participants randomized. | percentage of participants | NUMBER |
| SECONDARY | Tumor Control Rate (CR+PR+SD) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Up to 24 months | The Intent-to-treat population includes all participants randomized. | percentage of participants | NUMBER |
| PRIMARY | Survival at 24 Months in the Intent-to-treat Population - Number of Participants | 24 months | The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented. | participants | NUMBER |
| SECONDARY | Median Duration of Response (Days) by Independent Review (Descriptive Analysis, Only) | Up to 24 months | The Intent-to-treat population includes all participants randomized. | days | MEDIAN |
| SECONDARY | Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants | 10, 12, 14, 16, 18, 21, and 24 months | The Intent-to-treat population includes all participants randomized. | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Trabedersen 10 µM | 28.6 | 95% Confidence Interval 11.7 to 54.6 | percentage of participants | |
| Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Chemotherapy | 15.4 | 95% Confidence Interval 4.3 to 42.2 | percentage of participants | |
| Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Trabedersen 10 µM | Survival rates at 12 months | 57.1 | 95% Confidence Interval 32.6 to 78.6 | percentage of participants |
| Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Chemotherapy | Survival rates at 12 months | 53.8 | 95% Confidence Interval 29.1 to 76.8 | percentage of participants |
| Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Trabedersen 10 µM | Survival rates at 18 months | 42.9 | 95% Confidence Interval 21.4 to 67.4 | percentage of participants |
| Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Chemotherapy | Survival rates at 18 months | 38.5 | 95% Confidence Interval 17.7 to 64.5 | percentage of participants |
| Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Trabedersen 10 µM | Survival rates at 21 months | 35.7 | 95% Confidence Interval 16.3 to 61.2 | percentage of participants |
| Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only) | Chemotherapy | Survival rates at 21 months | 23.1 | 95% Confidence Interval 8.2 to 50.3 | percentage of participants |
| Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants | Trabedersen 10 µM | Alive at 12 months | 8 | participants | |
| Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants | Chemotherapy | Alive at 12 months | 7 | participants |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization to First Dose | STARTED | Trabedersen 10 µM | 14 | |
| Randomization to First Dose | STARTED | Chemotherapy | 13 | |
| Randomization to First Dose | Catheter Surgery | Trabedersen 10 µM | 13 | |
| Randomization to First Dose | Catheter Surgery | Chemotherapy | 0 | |
| Randomization to First Dose | First Dose of Study Drug / Chemotherapy | Trabedersen 10 µM | 12 | |
| Randomization to First Dose | First Dose of Study Drug / Chemotherapy | Chemotherapy | 11 | |
| Randomization to First Dose | COMPLETED | Trabedersen 10 µM | 12 | |
| Randomization to First Dose | COMPLETED | Chemotherapy | 11 | |
| Randomization to First Dose | NOT COMPLETED | Trabedersen 10 µM | 2 | |
| Randomization to First Dose | NOT COMPLETED | Chemotherapy | 2 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events224
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 | Headache | Nervous system disorders | Trabedersen 10 µM | 7 | 13 | 7 |
| other | Headache | Nervous system disorders | Chemotherapy | 2 | 11 | 2 |
| other | Partial seizures | Nervous system disorders | Trabedersen 10 µM | 4 | 13 | 4 |
| other | Partial seizures | Nervous system disorders | Chemotherapy | 0 | 11 | 0 |
| other | Brain oedema | Nervous system disorders | Trabedersen 10 µM | 3 | 13 | 3 |
| other | Brain oedema | Nervous system disorders | Chemotherapy | 0 | 11 | 0 |
| other | Dizziness | Nervous system disorders | Trabedersen 10 µM | 2 | 13 | 2 |
| other | Dizziness | Nervous system disorders | Chemotherapy | 1 | 11 | 1 |
| other | Hemiparesis | Nervous system disorders | Trabedersen 10 µM | 2 | 13 | 2 |
| other | Hemiparesis | Nervous system disorders | Chemotherapy | 1 | 11 | 1 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trabedersen 10 µM | ||
| Total, all-cause mortality | Chemotherapy | ||
| Total, other adverse events | Trabedersen 10 µM | 12 | 13 |
| Total, other adverse events | Chemotherapy | 9 | 11 |
| Total, serious adverse events | Trabedersen 10 µM | 6 | 13 |
| Total, serious adverse events | Chemotherapy | 0 | 11 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Trabedersen 10 µM vs Chemotherapy: serious adverse events |
Source 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/NCT00761280
GET https://conductscience.org/api/trials/v1/NCT00761280/results?page=2