Trial · NCT01663012
Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma
NCT01663012, Phase 2, Completed, Lawrence Recht; results first posted 2015-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma. Trials, record NCT01663012. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01663012
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma
- NCT number
- NCT01663012
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Lawrence Recht
- Conditions
- Anaplastic Astrocytomas, Anaplastic Oligodendrogliomas, Glioblastomas (GBM)
- Interventions
- Etirinotecan pegol
- First posted
- 2012-08-13
- Last updated
- 2016-02-24
- Results first posted
- 2015-06-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival, Assessed by Revised Assessment in Neuro-oncology (RANO) Criteria | 6 weeks from first administration of NKTR-102 | Will be described using Kaplan-Meier estimates. The PFS probability at 6 weeks (PFS-6week) will be estimated with an 80% power and 95% confidence intervals (80% in accord with the planned alpha level, 95% for comparability with other studies, confidence intervals based on the Greenwood formula for the variance of a survival probability). |
| Secondary | Survival From the Time of First NKTR-102 Dose for Patients With BEV-resistant Glioma Receiving NKTR-102 to Date of Death | From date of first dose of NKTR-102 to date of death, assessed up to 2 years | Will be described using Kaplan-Meier estimates. |
| Secondary | Overall Survival From Time of Diagnosis | From date of pathologic diagnosis/confirmation of high grade glioma to date of death, assessed up to 2 years. | Will be described using Kaplan-Meier estimates. |
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 | Progression Free Survival, Assessed by Revised Assessment in Neuro-oncology (RANO) Criteria | 6 weeks from first administration of NKTR-102 | participants | NUMBER | |
| SECONDARY | Survival From the Time of First NKTR-102 Dose for Patients With BEV-resistant Glioma Receiving NKTR-102 to Date of Death | From date of first dose of NKTR-102 to date of death, assessed up to 2 years | Months | MEDIAN | |
| SECONDARY | Overall Survival From Time of Diagnosis | From date of pathologic diagnosis/confirmation of high grade glioma to date of death, assessed up to 2 years. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival, Assessed by Revised Assessment in Neuro-oncology (RANO) Criteria | Drug: Etirinotecan Pegol | 11 | participants | ||
| Survival From the Time of First NKTR-102 Dose for Patients With BEV-resistant Glioma Receiving NKTR-102 to Date of Death | Drug: Etirinotecan Pegol | 4.5 | 95% Confidence Interval 2.4 to 5.9 | Months | |
| Overall Survival From Time of Diagnosis | Drug: Etirinotecan Pegol | 17.1 | 95% Confidence Interval 10.0 to 36.6 | Months |
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 | Drug: Etirinotecan Pegol | 20 | |
| Overall Study | COMPLETED | Drug: Etirinotecan Pegol | 20 | |
| Overall Study | NOT COMPLETED | Drug: Etirinotecan Pegol | 0 |
Source ClinicalTrials.gov
Adverse events61
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 | Neutrophil Count Decreased | Blood and lymphatic system disorders | Drug: Etirinotecan Pegol | 3 | 20 | 4 |
| other | Palpitations | Cardiac disorders | Drug: Etirinotecan Pegol | 1 | 20 | 2 |
| other | Blurred Vision | Eye disorders | Drug: Etirinotecan Pegol | 9 | 20 | 13 |
| other | Dry Eye | Eye disorders | Drug: Etirinotecan Pegol | 1 | 20 | 1 |
| other | Eye Twitching | Eye disorders | Drug: Etirinotecan Pegol | 2 | 20 | 2 |
| other | Pressure Behind Eyes | Eye disorders | Drug: Etirinotecan Pegol | 1 | 20 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Drug: Etirinotecan Pegol | 5 | 20 | 7 |
| other | Constipation | Gastrointestinal disorders | Drug: Etirinotecan Pegol | 8 | 20 | 8 |
| other | Diarrhea | Gastrointestinal disorders | Drug: Etirinotecan Pegol | 14 | 20 | 41 |
| other | Fecal Incontinence | Gastrointestinal disorders | Drug: Etirinotecan Pegol | 1 | 20 | 1 |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Drug: Etirinotecan Pegol | ||
| Total, other adverse events | Drug: Etirinotecan Pegol | 20 | 20 |
| Total, serious adverse events | Drug: Etirinotecan Pegol | 5 | 20 |
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/NCT01663012
GET https://conductscience.org/api/trials/v1/NCT01663012/events?page=2