Trial · NCT01259089
Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer
NCT01259089, Phase 1, Phase 2, Completed, Northwestern University; results first posted 2018-11-21
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer. Trials, record NCT01259089. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01259089
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer
- NCT number
- NCT01259089
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Adenocarcinoma of the Lung, Non-small Cell Lung Cancer
- Interventions
- erlotinib hydrochloride, Hsp90 inhibitor AUY922, laboratory biomarker analysis, needle biopsy, mutation analysis, pharmacological study
- First posted
- 2010-12-13
- Last updated
- 2019-09-11
- Results first posted
- 2018-11-21
- Limitations and caveats
- Data was collected up until September 30 2014 when study was closed permanently and no further data was collected for patients survival due to IND withdrawal.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I) | During the first 4 weeks of treatment for each patient. | To determine the maximally tolerated dose (MTD), and recommended phase II dose of AUY922 when given in combination with erlotinib for patients with acquired resistance to erlotinib. (Phase I) Escalation of dose will be in a 3+3 design. If no dose limiting toxicities (DLTs) are seen in 3 patients enrolled at that dose level, then dose will be escalated to the next dose level and the next 3 patients will be enrolled at that dose. Alternatively, if 1 DLT is seen in 3 patients at that dose level, 3 more patients will be added at that same dose level. If 1 DLT is seen in 6 patients at that dose level, MTD will be determined to be at that dose. If more than 1 DLT is seen at that dose level, then the prior lower dose level will be the considered the MTD. DLT is defined as any of the following related to the investigational agent: Death and grade 3 and 4 specific hematological and non-hematological toxicities defined in the protocol. |
| Primary | Overall Response Rate (ORR), Defined as Complete Response(CR) + Partial Response (PR) Using the Modified RECIST 1.1 Criteria for All Patients Treated at Dose of 70mg/m2 AUG922 | At 8 weeks from treatment initiation | Overall response rate (ORR) will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI: Complete response (CR) defined as disappearance of all target lesions. Partial Response (PR), defined as \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. Progressive Disease (PD) defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions |
| Secondary | Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II) | At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment for up to 2 years and half years | To characterize the toxicity profile for the combination of erlotinib and AUY922. Toxicity data will be collected every week for the first 28 day cycle and then every two weeks during treatment and up to 28 days after the last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE |
| Secondary | Incidence of Reported Adverse Events in Phase I | At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment, for up to 2 years and half years | Adverse events will be collected weekly for the first 28 day cycle and then every two weeks during treatment and up to 28 days after the last treatment. Adverse events will be graded according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE |
| Secondary | Progression-free Survival (Phase II) | From the time of first treatment with AUY922 to disease progression for up to 2 years post treatment | Median Progression Free Survival (PFS) will be calculated from time of treatment initiation until the first documentation of progressive disease. Patients will be considered to have progressive disease when CT scan or MRI show at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Secondary | Overall Survival (Phase II) | From the time of first treatment with AUY922 to death, followed up to 2 years post treatment | Overall survival (OS) is defined as the time from treatment initiation until death due to any cause. |
| Secondary | Overall Survival Among Patients With Acquired Resistance With T790M Mutations (Phase II) | From the time of first treatment with AUY922 to death, followed for up to 2 years | Overall Survival (OS) will be measured from treatment initiation until death due to any cause for patients with acquired resistance with T790M mutations in the phase II portion of the study. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I) | During the first 4 weeks of treatment for each patient. | Number of DLTs seen | NUMBER | |
| PRIMARY | Overall Response Rate (ORR), Defined as Complete Response(CR) + Partial Response (PR) Using the Modified RECIST 1.1 Criteria for All Patients Treated at Dose of 70mg/m2 AUG922 | At 8 weeks from treatment initiation | All patients that were treated at the MTD dose of 70mg/m2 AUG922 IV were evaluable for this outcome measure (This includes patients treated in cohort 5 of phase I and all patients treated in phase II of the study) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II) | At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment for up to 2 years and half years | Toxicity collected from all patients treated at the MTD of 70mg/m2 AUY922. 6 patients in phase I and 19 patients in phase II were treated at this dose. | participants | NUMBER |
| SECONDARY | Incidence of Reported Adverse Events in Phase I | At weeks 1 through 4 and then every 2 weeks during treatment and 30 days post last treatment, for up to 2 years and half years | Most frequent adverse events for patients treated with 25 to 55mg/m2 dose of AUY9222. | participants | NUMBER |
| SECONDARY | Progression-free Survival (Phase II) | From the time of first treatment with AUY922 to disease progression for up to 2 years post treatment | 25 of the patients were treated at the MTD and were evaluable for progression free survival. Data was collected up until September 30 2014 when study was closed permanently and no further data was collected for patients survival due to IND withdrawal. | Months | MEDIAN |
| SECONDARY | Overall Survival (Phase II) | From the time of first treatment with AUY922 to death, followed up to 2 years post treatment | 25 of the patients were treated at the MTD and were evaluable for progression free survival. Data was collected up until September 30 2014 when study was closed permanently and no further data was collected for patients survival due to IND withdrawal. | Months | MEDIAN |
| SECONDARY | Overall Survival Among Patients With Acquired Resistance With T790M Mutations (Phase II) | From the time of first treatment with AUY922 to death, followed for up to 2 years | No data was collected or analyzed for this outcome measure. There is no data to report. IND was withdrawn before the studies anticipated termination date. |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I) | Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib | 0 | Number of DLTs seen | ||
| Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I) | Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib | 0 | Number of DLTs seen | ||
| Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I) | Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib | 0 | Number of DLTs seen | ||
| Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I) | Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib | 0 | Number of DLTs seen | ||
| Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I) | Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib | 1 | Number of DLTs seen | ||
| Overall Response Rate (ORR), Defined as Complete Response(CR) + Partial Response (PR) Using the Modified RECIST 1.1 Criteria for All Patients Treated at Dose of 70mg/m2 AUG922 | Arm I | 4 | Participants | ||
| Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II) | Arm I | Diarrhea | 24 | participants | |
| Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II) | Arm I | Skin rash | 16 | participants | |
| Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II) | Arm I | Hyperglycemia | 23 | participants | |
| Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II) | Arm I | Night blindness | 18 | participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow84
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Reached First Response at 4 Weeks | STARTED | Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib | 3 | |
| Reached First Response at 4 Weeks | STARTED | Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib | 3 | |
| Reached First Response at 4 Weeks | STARTED | Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib | 3 | |
| Reached First Response at 4 Weeks | STARTED | Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib | 3 | |
| Reached First Response at 4 Weeks | STARTED | Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib | 6 | |
| Reached First Response at 4 Weeks | STARTED | Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib | 20 | |
| Reached First Response at 4 Weeks | Started Treatment on Study | Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib | 3 | |
| Reached First Response at 4 Weeks | Started Treatment on Study | Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib | 3 | |
| Reached First Response at 4 Weeks | Started Treatment on Study | Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib | 3 | |
| Reached First Response at 4 Weeks | Started Treatment on Study | Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib | 3 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events780
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 | Anemia | Blood and lymphatic system disorders | Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib | 1 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib | 1 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib | 0 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib | 0 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib | 1 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib | 3 | 19 | |
| other | Atrioventricular block first degree | Cardiac disorders | Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib | 1 | 3 | |
| other | Atrioventricular block first degree | Cardiac disorders | Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib | 0 | 3 | |
| other | Atrioventricular block first degree | Cardiac disorders | Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib | 0 | 3 | |
| other | Atrioventricular block first degree | Cardiac disorders | Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib | 0 | 3 |
1 to 10 of 780Source ClinicalTrials.gov
See all 780 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib | 3 | 3 |
| Total, all-cause mortality | Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib | 3 | 3 |
| Total, all-cause mortality | Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib | 3 | 3 |
| Total, all-cause mortality | Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib | 3 | 3 |
| Total, all-cause mortality | Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib | 6 | 6 |
| Total, all-cause mortality | Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib | 13 | 19 |
| Total, other adverse events | Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib | 3 | 3 |
| Total, other adverse events | Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib | 3 | 3 |
| Total, other adverse events | Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib | 3 | 3 |
| Total, other adverse events | Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib | 3 | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25870087 | 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/NCT01259089
GET https://conductscience.org/api/trials/v1/NCT01259089/results?page=2