Trial · NCT01193868
RO4929097 in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Recently Completed Treatment With Front-Line Chemotherapy
NCT01193868, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2015-11-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. RO4929097 in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Recently Completed Treatment With Front-Line Chemotherapy. Trials, record NCT01193868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01193868
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RO4929097 in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Recently Completed Treatment With Front-Line Chemotherapy
- NCT number
- NCT01193868
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Interventions
- gamma-secretase/Notch signalling pathway inhibitor RO4929097, laboratory biomarker analysis, pharmacological study
- First posted
- 2010-09-02
- Last updated
- 2015-11-18
- Results first posted
- 2015-11-18
- Limitations and caveats
- The study closed June 2012 with the NCI discontinuation production of the study drug RO4929097.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) | Response evaluation every 6 weeks (in addition to baseline scan, confirmatory scans approximately 6-7 (not less than 4) weeks following initial documentation of objective response). Expected follow up to 5 years, actual study period 9/2010 to 4/2014. | Percentage of participants with response per RECIST version 1.1: Complete Response (CR):Disappearance all target lesions. Any pathological lymph nodes with reduction in short axis to \<10 mm. Partial Response (PR): At least 30% decrease in sum of diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): At least 20% increase in sum of diameters of target lesions, reference smallest sum on study (includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must demonstrate an absolute increase of at least 5 mm. (Note: appearance of 1 or more new lesions also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study. Best response recorded from treatment start until disease progression/recurrence (reference for progressive disease the smallest measurements recorded since treatment started). |
| Primary | Percentage of Tumor Shrinkage as a Continuous Variable | 6 weeks | Response is reported as a continuous variable, as % change in tumor size from baseline. Pearson and Spearman correlation coefficients will be used. Reported with 95% two-sided confidence intervals. |
| Secondary | Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in This Population vs Tumor Bank Population | Up to day 3 | For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Wilcoxon rank sum tests). Spearman coefficients will be used to correlate tumor expression of Notch pathway markers with expression of stem cell markers. |
| Secondary | Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With Versus Without a Particular Host Genotype Polymorphism | Up to day 3 | Wilcoxon rank sum tests will be used. For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Wilcoxon rank sum tests). |
| Secondary | Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Epidermal Growth Factor Receptor (EGFR) Activating Mutations | Up to day 3 | Wilcoxon rank sum tests will be used. Compared using Fisher Exact Tests. For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Sum Test). Spearman coefficients will be used to correlate tumor expression of Notch pathway markers with expression of stem cell markers. |
| Secondary | Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Response by RECIST Criteria | Up to day 3 | Wilcoxon rank sum tests will be used. |
| Secondary | Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Tumor Progression | Up to 3 months | Tumor Immunohistochemistry (IHC) scores for Notch pathway and stem cell markers used in comparison to tumor progression; and progression evaluated in using international criteria proposed by revised RECIST guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Wilcoxon rank sum tests will be used. Compared using Fisher Exact Tests. |
| Secondary | Correlation of Tumor Shrinkage/Response With Biomarker Expression | 6 weeks | Correlate percent change in tumor size at 6 weeks (or at time off study, if therapy is stopped earlier due to tumor progression) with tumor Immunohistochemistry (IHC) scores for Notch pathway and stem cell markers; Tumor % shrinkage with RO4929097 will correlate with pre-therapy tumor expression of Notch pathway members, with expression of stem cell markers, and with changes in these over the first cycle of therapy. |
| Secondary | Progression-free Survival | Baseline up to 5 years | Time from initiation of study drug until death, progression of tumor, or for worsening of tumor that did not meet RECIST 1.1 criteria but that did require discontinuation of therapy, assessed up to 5 years |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) | Response evaluation every 6 weeks (in addition to baseline scan, confirmatory scans approximately 6-7 (not less than 4) weeks following initial documentation of objective response). Expected follow up to 5 years, actual study period 9/2010 to 4/2014. | Only those participants who have measurable disease present at baseline and received at least one dose of study medication considered evaluable for response with their response classified according to the RECIST definitions stated. Participants who exhibit objective disease progression prior to the end of cycle 1 also considered evaluable. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Tumor Shrinkage as a Continuous Variable | 6 weeks | Study terminated early with low accrual leading to insufficient data for analysis. | ||
| SECONDARY | Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in This Population vs Tumor Bank Population | Up to day 3 | Study terminated early with low accrual leading to insufficient data for analysis. | ||
| SECONDARY | Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With Versus Without a Particular Host Genotype Polymorphism | Up to day 3 | Study terminated early with low accrual leading to insufficient data for analysis. | ||
| SECONDARY | Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Epidermal Growth Factor Receptor (EGFR) Activating Mutations | Up to day 3 | Study terminated early with low accrual leading to insufficient data for analysis. | ||
| SECONDARY | Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Response by RECIST Criteria | Up to day 3 | Study terminated early. Analysis not performed due to small numbers. | ||
| SECONDARY | Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Tumor Progression | Up to 3 months | Study terminated early with low accrual leading to insufficient data for analysis. | ||
| SECONDARY | Correlation of Tumor Shrinkage/Response With Biomarker Expression | 6 weeks | Study terminated early. Analysis not performed due to small numbers. | ||
| SECONDARY | Progression-free Survival | Baseline up to 5 years | Study terminated early. Analysis not performed due to small numbers. |
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 |
|---|---|---|---|---|---|
| Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) | RO4929097 | Complete Response (CR) | 0 | percentage of participants | |
| Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) | RO4929097 | Partial Response (PR) | 0 | percentage of participants | |
| Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) | RO4929097 | Progression (PD) | 100 | percentage of participants | |
| Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) | RO4929097 | Stable Disease (SD) | 0 | percentage of 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 | RO4929097 | 6 | |
| Overall Study | COMPLETED | RO4929097 | 6 | |
| Overall Study | NOT COMPLETED | RO4929097 | 0 |
Source ClinicalTrials.gov
Adverse events58
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 | Abdominal pain | Gastrointestinal disorders | RO4929097 | 1 | 6 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | RO4929097 | 1 | 6 | 1 |
| other | Alkaline phosphatase increased | Investigations | RO4929097 | 3 | 6 | 3 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | RO4929097 | 1 | 6 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | RO4929097 | 1 | 6 | 1 |
| other | Anemia | Blood and lymphatic system disorders | RO4929097 | 6 | 6 | 9 |
| other | Anorexia | Metabolism and nutrition disorders | RO4929097 | 2 | 6 | 2 |
| other | Anxiety | Psychiatric disorders | RO4929097 | 2 | 6 | 2 |
| other | Aspartate aminotransferase increased | Investigations | RO4929097 | 1 | 6 | 2 |
| other | Aspiration | Respiratory, thoracic and mediastinal disorders | RO4929097 | 1 | 6 | 1 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RO4929097 | ||
| Total, other adverse events | RO4929097 | 6 | 6 |
| Total, serious adverse events | RO4929097 | 4 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| 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 |
Source 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/NCT01193868
GET https://conductscience.org/api/trials/v1/NCT01193868/events?page=2