Trial · NCT00826241
Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma
NCT00826241, Phase 2, Completed, National Institutes of Health Clinical Center (CC); results first posted 2019-03-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma. Trials, record NCT00826241. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00826241
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma
- NCT number
- NCT00826241
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Conditions
- Brain Tumors, Spinal Cord Tumors
- Interventions
- Temozolomide, Lapatinib
- First posted
- 2009-01-22
- Last updated
- 2019-03-22
- Results first posted
- 2019-03-22
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Progression | Assessed every two months till disease progression, up to 4 years | Time to progression defined as progressive disease, toxicity at a level of severity that precludes the patient continuing on the protocol, or death. Progression is a 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). |
| Secondary | Number of Participants With an Overall Response (Complete Response or Partial Response) Assessed by the MacDonald Criteria | 4 weeks | Anti-tumor activity as determined by the overall response (Complete response (CR) or partial response (PR)) was assessed by the MacDonald criteria. Complete response is complete resolution of all lesions. The patient cannot be on any corticosteroids with the exception of adrenal replacement doses. Partial response is ≥50% reduction in the sum of products of all measurable lesions over baseline sum observed using the same techniques as baseline. The patient must be on a stable or decreased dose of corticosteroids to be evaluable for response. |
| Secondary | Number of Participants With Serious and Non-Serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 111 months and 26 days | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
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 | Time to Progression | Assessed every two months till disease progression, up to 4 years | 8 patients were not evaluable/replaced: 2 - withdrew,1 - non-compliant, 2 - screen failures, 1 - could not obtain records, 1 - opted not to proceed with treatment, and 1 - unable to proceed to registration. | Months | MEDIAN |
| SECONDARY | Number of Participants With an Overall Response (Complete Response or Partial Response) Assessed by the MacDonald Criteria | 4 weeks | 8 patients were not evaluable/replaced: 2 - withdrew,1 - non-compliant, 2 - screen failures, 1 - could not obtain records, 1 - opted not to proceed with treatment, and 1 - unable to proceed to registration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious and Non-Serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 111 months and 26 days | 8 patients were not evaluable/replaced: 2 - withdrew,1 - non-compliant, 2 - screen failures, 1 - could not obtain records, 1 - opted not to proceed with treatment, and 1 - unable to proceed to registration. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Progression | Temozolomide + Lapatinib | 7.8 | 95% Confidence Interval 5.2 to 12.2 | Months | |
| Number of Participants With an Overall Response (Complete Response or Partial Response) Assessed by the MacDonald Criteria | Temozolomide + Lapatinib | Complete Response | 2 | Participants | |
| Number of Participants With an Overall Response (Complete Response or Partial Response) Assessed by the MacDonald Criteria | Temozolomide + Lapatinib | Partial Response | 8 | Participants | |
| Number of Participants With Serious and Non-Serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Temozolomide + Lapatinib | 50 | Participants |
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 | Temozolomide + Lapatinib | 58 | |
| Overall Study | COMPLETED | Temozolomide + Lapatinib | 31 | |
| Overall Study | NOT COMPLETED | Temozolomide + Lapatinib | 27 |
Source ClinicalTrials.gov
Adverse events256
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 | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Temozolomide + Lapatinib | 6 | 50 | 20 |
| other | Alkaline phosphatase | Investigations | Temozolomide + Lapatinib | 7 | 50 | 18 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Respiratory, thoracic and mediastinal disorders | Temozolomide + Lapatinib | 3 | 50 | 6 |
| other | Allergy/Immunology - Other (Specify, environmental allergic dry cough) | Immune system disorders | Temozolomide + Lapatinib | 1 | 50 | 2 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Temozolomide + Lapatinib | 17 | 50 | 54 |
| other | Amylase | Investigations | Temozolomide + Lapatinib | 1 | 50 | 2 |
| other | Anorexia | Metabolism and nutrition disorders | Temozolomide + Lapatinib | 10 | 50 | 22 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Temozolomide + Lapatinib | 16 | 50 | 50 |
| other | Ataxia (incoordination) | Nervous system disorders | Temozolomide + Lapatinib | 6 | 50 | 14 |
| other | Auditory/Ear - Other (Specify, fluttering sensation) | Ear and labyrinth disorders | Temozolomide + Lapatinib | 1 | 50 | 2 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temozolomide + Lapatinib | 4 | 50 |
| Total, other adverse events | Temozolomide + Lapatinib | 50 | 50 |
| Total, serious adverse events | Temozolomide + Lapatinib | 13 | 50 |
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/NCT00826241
GET https://conductscience.org/api/trials/v1/NCT00826241/events?page=2