Trial · NCT01232829
Gamma Secretase Inhibitor RO4929097 in Previously Treated Metastatic Pancreas Cancer
NCT01232829, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gamma Secretase Inhibitor RO4929097 in Previously Treated Metastatic Pancreas Cancer. Trials, record NCT01232829. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01232829
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gamma Secretase Inhibitor RO4929097 in Previously Treated Metastatic Pancreas Cancer
- NCT number
- NCT01232829
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer
- Interventions
- gamma-secretase/Notch signalling pathway inhibitor RO4929097
- First posted
- 2010-11-02
- Last updated
- 2014-11-26
- Results first posted
- 2014-11-26
- Limitations and caveats
The study met criteria to accrue 32 subjects but only 18 were enrolled. It was decided to stop further enrollment after RO4929097 was discontinued by the sponsor and was no longer a development candidate.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival Rate | 6 months | The primary endpoint of the study was 6-month survival. The proportion of successes was estimated by the number of successes divided by the total number of evaluable patients. |
| Secondary | Survival | From registration to death due to any cause, assessed up to 2 years | Survival was estimated using the Kaplan-Meier (1958) method. |
| Secondary | Time to Disease Progression | From registration to documentation of disease progression, assessed up to 2 years | Eighteen patients were evaluable for the time to disease progression endpoint. |
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 | Survival Rate | 6 months | All patients meeting the eligibility criteria and who received treatment were considered evaluable for the primary endpoint. All patients treated per protocol (n=18) were evaluable for the 6-month survival endpoint. | participants | NUMBER |
| SECONDARY | Survival | From registration to death due to any cause, assessed up to 2 years | All patients meeting the eligibility criteria and who received treatment per protocol (n=18) were evaluable for the overall survival endpoint. | months | MEDIAN |
| SECONDARY | Time to Disease Progression | From registration to documentation of disease progression, assessed up to 2 years | All patients meeting the eligibility criteria and who received treatment per protocol (n=18) were evaluable for the progression-free survival. | 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 |
|---|---|---|---|---|---|
| Survival Rate | Treatment (RO4929097) | 5 | participants | ||
| Survival | Treatment (RO4929097) | 4.1 | 95% Confidence Interval 2.7 to 5.8 | months | |
| Time to Disease Progression | Treatment (RO4929097) | 1.5 | 95% Confidence Interval 1.3 to 1.6 | 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 | Treatment (RO4929097) | 18 | |
| Overall Study | COMPLETED | Treatment (RO4929097) | 18 | |
| Overall Study | NOT COMPLETED | Treatment (RO4929097) | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Hyperglycemia | Metabolism and nutrition disorders | Treatment (RO4929097) | 2 | 18 | |
| other | Fatigue | General disorders | Treatment (RO4929097) | 2 | 18 | |
| other | Dysgeusia | Nervous system disorders | Treatment (RO4929097) | 1 | 18 | |
| other | Lymphocyte Count Decreased | Investigations | Treatment (RO4929097) | 2 | 18 | |
| other | Hypophosphatemia | Metabolism and nutrition disorders | Treatment (RO4929097) | 1 | 18 | |
| serious | Confusion | Psychiatric disorders | Treatment (RO4929097) | 1 | 18 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (RO4929097) | ||
| Total, other adverse events | Treatment (RO4929097) | 8 | 18 |
| Total, serious adverse events | Treatment (RO4929097) | 1 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 |
|---|---|---|---|---|---|---|
| P30CA046934 | University of Colorado Cancer Center Support Grant | DEGREGORI, JAMES V | UNIVERSITY OF COLORADO DENVER | NATIONAL CANCER INSTITUTE | 1988 to 2025 | NIH RePORTER |
| U01CA070095 | Phase I Clinical Trials of New Anti-Cancer Targeted Therapies | CARDUCCI, MICHAEL A | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1995 to 2013 | NIH RePORTER |
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/NCT01232829
GET https://conductscience.org/api/trials/v1/NCT01232829/registered