Trial · NCT01217411
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
NCT01217411, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2015-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer. Trials, record NCT01217411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01217411
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
- NCT number
- NCT01217411
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma, HER2/Neu Negative, HER2/Neu Positive, Male Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain, Recurrent Breast Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma, Recurrent Melanoma, Stage IV Breast Cancer AJCC v6 and v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IV Lung Non-Small Cell Cancer AJCC v7
- Interventions
- Cognitive Assessment, Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis, Stereotactic Radiosurgery, Whole-Brain Radiotherapy
- First posted
- 2010-10-08
- Last updated
- 2024-11-19
- Results first posted
- 2015-02-06
- Limitations and caveats
- Due to small number of patients enrolled on study, researchers were unable to make meaningful conclusions from the data.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1 Arm I Maximum-tolerated Dose (MTD) of RO4929097 in Combination With Whole-brain Radiotherapy (WBRT) | 4 weeks | Maximum-tolerated dose (MTD) of RO4929097 in combination with WBRT, determined according to incidence of dose limiting toxicity (DLT) graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) |
| Primary | Phase 1 Arm II MTD of RO4929097 in Combination With Stereotactic Surgery (SRS) | 4 weeks | MTD of RO4929097 in combination with SRS, determined according to incidence of DLT graded using the NCI CTCAE version 4.0 (phase I) |
| Primary | Response Rate (Complete or Partial Response) | 12 weeks | Only participants with measurable disease present at baseline, received at least 6 weeks of therapy, and had disease re-evaluated considered evaluable for response. Complete Response (CR): Disappearance all lesions; Partial Response (PR): =/\>50% decrease in sum bidimensional products all lesions reference baseline sum of bidimensional products of all lesions; Progressive Disease (PD): \>25% increase in sum bidimensional products of lesions, or progression of any treated lesion not target lesion, or appearance of 1 or \> new lesions at least 6 mm in unidimensional size. Stable Disease (SD): Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum of bidimensional products of all lesions. |
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 | Phase 1 Arm I Maximum-tolerated Dose (MTD) of RO4929097 in Combination With Whole-brain Radiotherapy (WBRT) | 4 weeks | Analysis was not available due to small number of patients on the study. | ||
| PRIMARY | Phase 1 Arm II MTD of RO4929097 in Combination With Stereotactic Surgery (SRS) | 4 weeks | Analysis was not available due to small number of patients on the study. | ||
| PRIMARY | Response Rate (Complete or Partial Response) | 12 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (Complete or Partial Response) | Phase I Arm I | 3 | Participants | ||
| Response Rate (Complete or Partial Response) | Phase 1 Arm II | 2 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1 Arm I (WBRT + R04929097) | 3 | |
| Overall Study | STARTED | Phase 1 Arm II (SRS + RO4929097) | 2 | |
| Overall Study | 5mg | Phase 1 Arm I (WBRT + R04929097) | 3 | |
| Overall Study | 5mg | Phase 1 Arm II (SRS + RO4929097) | 2 | |
| Overall Study | 10mg | Phase 1 Arm I (WBRT + R04929097) | 0 | |
| Overall Study | 10mg | Phase 1 Arm II (SRS + RO4929097) | 0 | |
| Overall Study | 20mg | Phase 1 Arm I (WBRT + R04929097) | 0 | |
| Overall Study | 20mg | Phase 1 Arm II (SRS + RO4929097) | 0 | |
| Overall Study | COMPLETED | Phase 1 Arm I (WBRT + R04929097) | 0 | |
| Overall Study | COMPLETED | Phase 1 Arm II (SRS + RO4929097) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events128
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 | Acidosis | Metabolism and nutrition disorders | Phase 1 Arm I (WBRT + R04929097) | 1 | 3 | 1 |
| other | Acidosis | Metabolism and nutrition disorders | Phase 1 Arm II (SRS + RO4929097) | 0 | 2 | 0 |
| other | Alanine aminotransferase increased | Investigations | Phase 1 Arm I (WBRT + R04929097) | 0 | 3 | |
| other | Alanine aminotransferase increased | Investigations | Phase 1 Arm II (SRS + RO4929097) | 1 | 2 | 1 |
| other | Alkaline phosphatase increased | Investigations | Phase 1 Arm I (WBRT + R04929097) | 1 | 3 | 2 |
| other | Alkaline phosphatase increased | Investigations | Phase 1 Arm II (SRS + RO4929097) | 0 | 2 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Phase 1 Arm I (WBRT + R04929097) | 2 | 3 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Phase 1 Arm II (SRS + RO4929097) | 0 | 2 | |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Arm I (WBRT + R04929097) | 2 | 3 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Arm II (SRS + RO4929097) | 1 | 2 | 2 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 Arm I (WBRT + R04929097) | ||
| Total, all-cause mortality | Phase 1 Arm II (SRS + RO4929097) | ||
| Total, other adverse events | Phase 1 Arm I (WBRT + R04929097) | 3 | 3 |
| Total, other adverse events | Phase 1 Arm II (SRS + RO4929097) | 2 | 2 |
| Total, serious adverse events | Phase 1 Arm I (WBRT + R04929097) | 1 | 3 |
| Total, serious adverse events | Phase 1 Arm II (SRS + RO4929097) | 1 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants4
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| U01CA062461 | Phase I Studies of Targeted Anti-Cancer Therapies | YAO, JAMES C | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
| U01CA069852 | Phase I Clinical Trials of Anti-Cancer Agents | RATAIN, MARK J | UNIVERSITY OF CHICAGO | NATIONAL CANCER INSTITUTE | 1995 to 2013 | NIH RePORTER |
| U01CA076576 | Phase I Trials of Anti-Cancer Agents | GREVER, MICHAEL R | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1998 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase I Arm I vs Phase 1 Arm II: Response Rate (Complete or Partial Response) | Trial comparisons |
| Phase 1 Arm I (WBRT + R04929097) vs Phase 1 Arm II (SRS + RO4929097): serious adverse events | 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/NCT01217411
GET https://conductscience.org/api/trials/v1/NCT01217411/events?page=2