Trial · NCT01193881
RO4929097 and Erlotinib Hydrochloride in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer
NCT01193881, Phase 1, Terminated, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RO4929097 and Erlotinib Hydrochloride in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer. Trials, record NCT01193881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01193881
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RO4929097 and Erlotinib Hydrochloride in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer
- NCT number
- NCT01193881
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 16 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer
- Interventions
- Erlotinib Hydrochloride, Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis, Pharmacological Study
- First posted
- 2010-09-02
- Last updated
- 2015-09-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events assessed using NCI CTCAE version 4.0 (Dose escalation phase) | Within 30 days of last drug dose | |
| Primary | Maximum-tolerated dose of RO4929097 and erlotinib hydrochloride defined as the highest dose tested causing dose limiting toxicity in < 2/6 patients assessed using National Cancer Institute (NCI) CTCAE version 4.0 (Dose escalation phase) | At least 3 weeks after day 1 of course 1 | |
| Primary | Percentage of change in expression of Notch and other tumor and blood biomarkers (Expansion cohort) | Baseline to 6 weeks | The differences before and after treatment will be assessed using a paired-t test on the log-transformed tumor sizes and a Wilcoxon signed-rank test. |
| Primary | Percentage of tumor shrinkage (Expansion cohort) | Up to 6 weeks | Will be correlated with response and baseline expression of biomarkers. The differences before and after treatment will be assessed using a paired-t test on the log-transformed tumor sizes and a Wilcoxon signed-rank test. |
| Primary | Response rate by RECIST 1.1 (Expansion cohort) | Up to 12 weeks | |
| Primary | Time to progression (Expansion cohort) | Up to 12 weeks | Will be correlated with baseline expression or biomarkers. |
| Other | Efficacy of this combination in unselected patients and in patients with intrinsic or acquired erlotinib resistance (Dose escalation phase) | Up to 12 weeks | |
| Other | Host Notch pathway gene polymorphisms | Up to 6 weeks | Correlations between Notch pathway gene polymorphisms and tumor and blood biomarkers will be assessed. Correlations between Notch pathway gene polymorphisms and tumor shrinkage/response on therapy will also be assessed. |
| Other | Pre-therapy tumor expression of Notch and other tumor and blood biomarkers (Dose escalation phase) | Baseline | Exploratory assessments of correlations of tumor shrinkage and response on the combination with pre-therapy tumor expression of Notch and other tumor and blood biomarkers will be conducted. |
| Other | Stem cell markers | Up to 6 weeks | Correlations between Notch pathway markers and stem cell markers will be assessed. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 |
|---|---|---|---|---|---|---|
| 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 |
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/NCT01193881
GET https://conductscience.org/api/trials/v1/NCT01193881/registered