Trial · NCT00826449
Dasatinib and Erlotinib in Non-Small Cell Lung Cancer (NSCLC)
NCT00826449, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2015-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib and Erlotinib in Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT00826449. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00826449
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib and Erlotinib in Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT00826449
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Lung Cancer, Non-Small Cell Lung Cancer
- Interventions
- Dasatinib, Erlotinib
- First posted
- 2009-01-22
- Last updated
- 2016-06-28
- Results first posted
- 2015-10-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Maximum Tolerable Dose (MTD) of Dasatinib Given With Erlotinib Hydrochloride | Baseline and at Day 21 | MTD defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Dose-limiting toxicity (DLT) defined using NCI Common Terminology Common Terminology Criteria for Adverse Events (CTCAE) version 3 as: grade 3 or higher non-hematologic toxicity (excluding initial nausea and vomiting), grade 4 neutropenia, febrile neutropenia, or grade 4 thrombocytopenia. Grade 3-4 nausea and vomiting that cannot be controlled within 2 weeks with anti-emetics considered a DLT. |
| Secondary | Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | 12 Weeks | Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Patients who have a partial or complete response or stable disease are defined as progression free. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase. |
| Secondary | Phase II: Progression-Free Survival (PFS) Rate | 12 Weeks | A modified Thall, Simon, and Estey (1995) design used in the phase II study to monitor the proportion of patients with NSCLC who are alive and progression free (PFS) at twelve weeks after commencing treatment with dasatinib and erlotinib. |
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 I: Maximum Tolerable Dose (MTD) of Dasatinib Given With Erlotinib Hydrochloride | Baseline and at Day 21 | mg/day | NUMBER | |
| SECONDARY | Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | 12 Weeks | One participant only received one day of therapy therefore was not evaluable for efficacy analyses; a second participant discontinued study treatment. | participants | NUMBER |
| SECONDARY | Phase II: Progression-Free Survival (PFS) Rate | 12 Weeks | Of the 35 participants in the Phase II portion of the study, one participant received one day of therapy therefore was not evaluable for efficacy analyses; a second participant discontinued study treatment. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I: Maximum Tolerable Dose (MTD) of Dasatinib Given With Erlotinib Hydrochloride | Dasatinib + Erlotinib | 70 | mg/day | ||
| Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Dasatinib + Erlotinib | Complete Response (CR) | 0 | participants | |
| Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Dasatinib + Erlotinib | Partial Response (PR) | 5 | participants | |
| Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Dasatinib + Erlotinib | Progressive Disease (PD) | 13 | participants | |
| Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Dasatinib + Erlotinib | Stable Disease (SD) | 15 | participants | |
| Phase II: Progression-Free Survival (PFS) Rate | Dasatinib + Erlotinib | 53 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib + Erlotinib | 47 | |
| Overall Study | Phase I | Dasatinib + Erlotinib | 12 | |
| Overall Study | Phase II | Dasatinib + Erlotinib | 35 | |
| Overall Study | COMPLETED | Dasatinib + Erlotinib | 42 | |
| Overall Study | NOT COMPLETED | Dasatinib + Erlotinib | 5 |
Source ClinicalTrials.gov
Adverse events100
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 | Dasatinib + Erlotinib | 5 | 47 | 7 |
| other | Acidosis | Metabolism and nutrition disorders | Dasatinib + Erlotinib | 1 | 47 | 2 |
| other | Activated partial thromboplastin time prolonged | Blood and lymphatic system disorders | Dasatinib + Erlotinib | 3 | 47 | 3 |
| other | Alanine aminotransferase increased | Metabolism and nutrition disorders | Dasatinib + Erlotinib | 9 | 47 | 10 |
| other | Alkaline phosphatase increased | Metabolism and nutrition disorders | Dasatinib + Erlotinib | 11 | 47 | 17 |
| other | Allergic rhinitis | Immune system disorders | Dasatinib + Erlotinib | 4 | 47 | 4 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Dasatinib + Erlotinib | 2 | 47 | 2 |
| other | Anorexia | Gastrointestinal disorders | Dasatinib + Erlotinib | 18 | 47 | 20 |
| other | Anxiety | Nervous system disorders | Dasatinib + Erlotinib | 7 | 47 | 7 |
| other | Arrhythmia supraventricular | Cardiac disorders | Dasatinib + Erlotinib | 1 | 47 | 1 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib + Erlotinib | ||
| Total, other adverse events | Dasatinib + Erlotinib | 47 | 47 |
| Total, serious adverse events | Dasatinib + Erlotinib | 3 | 47 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25170013 | DERIVED |
Source PubMed
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 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/NCT00826449
GET https://conductscience.org/api/trials/v1/NCT00826449/events?page=2