Trial · NCT02607124
A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy
NCT02607124, Phase 1, Phase 2, Terminated, Children's Hospital Medical Center, Cincinnati; results first posted 2020-11-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy. Trials, record NCT02607124. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02607124
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy
- NCT number
- NCT02607124
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Bithalamic High Grade Glioma
- Interventions
- Ribociclib
- First posted
- 2015-11-17
- Last updated
- 2020-11-05
- Results first posted
- 2020-11-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Adverse Events | 6 months | Primary feasibility endpoint is the number of individual toxicities and incidence of significant delays |
| Primary | Number of Patients Alive at One Year | 1 year |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Adverse Events | 6 months | Number of participants receiving investigational agent. | adverse event | NUMBER |
| PRIMARY | Number of Patients Alive at One Year | 1 year | Number of enrolled and evaluable participants | 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 |
|---|---|---|---|---|---|
| Number of Adverse Events | RB+ High Grade Glioma | 9 | adverse event | ||
| Number of Adverse Events | Non-Biopsied Diffuse Instrinsic Pontine Glioma | 144 | adverse event | ||
| Number of Patients Alive at One Year | RB+ High Grade Glioma | 0 | Participants | ||
| Number of Patients Alive at One Year | Non-Biopsied Diffuse Instrinsic Pontine Glioma | 8 | 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 | Non-Biopsied Diffuse Instrinsic Pontine Glioma/Diffuse Midline Glioma | 10 | |
| Overall Study | COMPLETED | Non-Biopsied Diffuse Instrinsic Pontine Glioma/Diffuse Midline Glioma | 10 | |
| Overall Study | NOT COMPLETED | Non-Biopsied Diffuse Instrinsic Pontine Glioma/Diffuse Midline Glioma | 0 |
Source ClinicalTrials.gov
Adverse events69
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 | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 6 | 10 | |
| other | Vomiting | Gastrointestinal disorders | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 8 | 10 | |
| other | Nausea | Gastrointestinal disorders | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 8 | 10 | |
| other | Constipation | Gastrointestinal disorders | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 2 | 10 | |
| other | Abdominal Pain | Gastrointestinal disorders | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 1 | 10 | |
| other | Dysphagia | Gastrointestinal disorders | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 1 | 10 | |
| other | Gastroesophageal reflux diease | Gastrointestinal disorders | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 1 | 10 | |
| other | Diarrhea | Gastrointestinal disorders | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 1 | 10 | |
| other | Fatigue | General disorders | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 8 | 10 | |
| other | Gait Disturbance | General disorders | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 1 | 10 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 10 | 10 |
| Total, other adverse events | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 10 | 10 |
| Total, serious adverse events | Diffuse Intrinsic Pontine Glioma and High Grade Glioma | 4 | 10 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| RB+ High Grade Glioma vs Non-Biopsied Diffuse Instrinsic Pontine Glioma: Number of Patients Alive at One Year |
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/NCT02607124
GET https://conductscience.org/api/trials/v1/NCT02607124/events?page=2