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Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01259089
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : November 21, 2018
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Robert H. Lurie Cancer Center
Information provided by (Responsible Party):
Northwestern University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Lung
Non-small Cell Lung Cancer
Interventions Drug: erlotinib hydrochloride
Drug: Hsp90 inhibitor AUY922
Other: laboratory biomarker analysis
Procedure: needle biopsy
Genetic: mutation analysis
Other: pharmacological study
Enrollment 38
Recruitment Details The study opened for accrual on March 28, 2011 with an accrual goal of up to 30 patients in phase I and 25 patients in phase II. 18 patients were enrolled treated in phase I and 19 patients treated in phase II. The study was closed permanently on May 6, 2013.
Pre-assignment Details  
Arm/Group Title Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib
Hide Arm/Group Description

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Period Title: Reached First Response at 4 Weeks
Started 3 3 3 3 6 20
Started Treatment on Study 3 3 3 3 6 19
Completed 4 Weeks of Treatment 3 3 3 3 6 18
Completed 3 3 3 3 6 18
Not Completed 0 0 0 0 0 2
Reason Not Completed
Patient not treated on study             0             0             0             0             0             1
Adverse Event             0             0             0             0             0             1
Period Title: Confirmed Response at 8 Weeks
Started 3 3 3 3 6 18
Completed 3 3 2 2 2 8
Not Completed 0 0 1 1 4 10
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             1
Adverse Event             0             0             0             0             1             2
Progressive disease             0             0             1             1             3             7
Period Title: Continued Treatment After 8 Weeks
Started 3 3 2 2 2 8
Completed 1 2 1 1 0 7
Not Completed 2 1 1 1 2 1
Reason Not Completed
Withdrawal by Subject             1             0             0             0             0             0
Adverse Event             0             0             0             0             2             1
Progressive disease             1             1             1             1             0             0
Period Title: Survival Follow up for Two Years
Started [1] 3 3 3 3 6 19
Completed 0 1 1 0 0 0
Not Completed 3 2 2 3 6 19
Reason Not Completed
Death             3             2             2             3             6             13
Lost to Follow-up             0             0             0             0             0             2
stopped being followed as study closed             0             0             0             0             0             4
[1]
All patients that are treated on study go into follow up once they finish treatment.
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
  65.8%
>=65 years
13
  34.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
28
  73.7%
Male
10
  26.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Hispanic or Latino
1
   2.6%
Not Hispanic or Latino
37
  97.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
American Indian or Alaska Native
0
   0.0%
Asian
11
  28.9%
Native Hawaiian or Other Pacific Islander
2
   5.3%
Black or African American
4
  10.5%
White
21
  55.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
1.Primary Outcome
Title Maximally Tolerated Dose (MTD) of AUY922 and Erlotinib Treatment Combination (Phase I)
Hide Description

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.

Time Frame During the first 4 weeks of treatment for each patient.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib
Hide Arm/Group Description:

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 3 3 3 3 6
Measure Type: Number
Unit of Measure: Number of DLTs seen
0 0 0 0 1
2.Primary Outcome
Title 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
Hide Description

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

Time Frame At 8 weeks from treatment initiation
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
4
  16.0%
3.Secondary Outcome
Title Toxicity as Assessed by NCI CTCAE Version 4.00 When AUG922 Administered at Its MTD (Phase I and II)
Hide Description

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

Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Diarrhea 24
Skin rash 16
Hyperglycemia 23
Night blindness 18
Hypoalbuminemia 21
Fatigue 11
Elevated AST 17
Nausea 9
Hyponatremia 17
Elevated bilirubin 16
Elevated ALT 14
Myalgias/arthralgias 9
Visual complaints 10
Vomiting 8
Elevated APL 10
Decreased leukocytes 10
Hypokalemia 10
Pruritis/dry skin 5
Hypocalcemia 8
Anemia 4
Mucositis 6
Decreased lymphocytes 6
Decreased platelets 6
Hypomagnesemia 6
Decreased neutrophils 5
4.Secondary Outcome
Title Incidence of Reported Adverse Events in Phase I
Hide Description

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

Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Most frequent adverse events for patients treated with 25 to 55mg/m2 dose of AUY9222.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
Diarrhea 11
Skin rash 9
Hyperglycemia 0
Night blindness 3
Hypoalbuminemia 0
Fatigue 8
Elevated AST 1
Nausea 8
Hyponatremia 0
Elevated bilirubin 0
Elevated ALT 0
Myalgias/arthralgias 5
Visual complaints 4
Vomiting 4
Elevated ALP 0
Decreased leukocytes 0
hypokalemia 0
Pruritis/dry skin 4
Hypocalcemia 0
anemia 2
Mucositis 0
Decreased lymphocytes 0
Decreased platelets 0
Hypomagnesemia 0
Decreased neutrophils 0
5.Secondary Outcome
Title Progression-free Survival (Phase II)
Hide Description 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.
Time Frame From the time of first treatment with AUY922 to disease progression for up to 2 years post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: Months
1.7
(1.1 to 4.9)
6.Secondary Outcome
Title Overall Survival (Phase II)
Hide Description Overall survival (OS) is defined as the time from treatment initiation until death due to any cause.
Time Frame From the time of first treatment with AUY922 to death, followed up to 2 years post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: Months
7.4
(4.0 to 17.9)
7.Secondary Outcome
Title Overall Survival Among Patients With Acquired Resistance With T790M Mutations (Phase II)
Hide Description 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.
Time Frame From the time of first treatment with AUY922 to death, followed for up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected weekly for the first 28 day cycle and then every two weeks up to 2 and half year period.
Adverse Event Reporting Description Only highest grade lab AEs were collected for each patient. All other AEs were collected as defined by clinicaltrials.gov. Phase I+II data collected together as toxicity objectives for the study were looking at AEs in relation to this combination of treatment rather than treatment dose.
 
Arm/Group Title Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib
Hide Arm/Group Description

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

Patients receive Hsp90 inhibitor AUY922 IV over 1 hour once weekly and 75mg oral erlotinib hydrochloride once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Hsp90 inhibitor AUY922: Given IV

laboratory biomarker analysis: Correlative studies

needle biopsy: Undergo image-guided needle biopsy (correlative studies)

mutation analysis: Correlative studies

pharmacological study: Correlative studies

All-Cause Mortality
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      13/19 (68.42%)    
Hide Serious Adverse Events
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      1/3 (33.33%)      1/3 (33.33%)      1/3 (33.33%)      2/6 (33.33%)      1/19 (5.26%)    
Cardiac disorders             
Conduction disorder  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/19 (0.00%)  0
Gastrointestinal disorders             
Diarrhea  1 [1]  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/19 (5.26%)  1
Lower gastrointestinal hemorrhage  1 [2]  0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/19 (0.00%)  0
Ileal obstruction  1 [3]  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/19 (0.00%)  0
Diarrhea with blood  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders             
Bone pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/19 (5.26%)  1
Tumor pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/19 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Progressive disease  1 [4]  0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/19 (0.00%)  0
Pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/19 (5.26%)  1
Nervous system disorders             
Memory impairment  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/19 (0.00%)  0
Cognitive disturbance  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders             
Dyspnea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/19 (5.26%)  2
Vascular disorders             
Thromboembolic event  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/19 (5.26%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Patient also experienced anemia
[2]
Patient also experienced diarrhea and anemia
[3]
Patient also had seizure due to not being able to take keppa because of nausea and vomiting.
[4]
Worsening symptoms included dyspnea and pleural effusion
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 - 25 mg/m2 AUY922+75 mg Daily Erlotinib Cohort 2 - 25 mg/m2AUY922+150 mg Daily Erlotinib Cohort 3 - 37.5 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 4 - 55 mg/m2 AUY922+150 mg Daily Erlotinib Cohort 5 - 70 mg/m2 AUY922+150 mg Daily Erlotinib Phase II- 70 mg/m2 AUY922+150 mg Daily Erlotinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      19/19 (100.00%)    
Blood and lymphatic system disorders             
Anemia  1  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  3/19 (15.79%) 
Bleeding  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/19 (5.26%) 
Bleeding gums  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Blood in sputum  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/19 (5.26%) 
Cardiac disorders             
Atrioventricular block first degree  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Chest pain  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Ear and labyrinth disorders             
Titnnitus  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Vertigo  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Eye disorders             
Blurred vision  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  3/19 (15.79%) 
Cataract  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Conjunctivitis  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Corneal ulcer  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Dry eye  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Flashing lights  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  0/19 (0.00%) 
Floaters  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/19 (5.26%) 
Night blindness  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  2/3 (66.67%)  4/6 (66.67%)  14/19 (73.68%) 
Visual Disturbances  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  3/19 (15.79%) 
Trichiasis of the eyelid  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Gastrointestinal disorders             
Cheilitis  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Constipation  1  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  2/3 (66.67%)  3/6 (50.00%)  3/19 (15.79%) 
Diarrhea  1  3/3 (100.00%)  3/3 (100.00%)  3/3 (100.00%)  2/3 (66.67%)  5/6 (83.33%)  19/19 (100.00%) 
Gastroesophageal reflux disease  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Hemorrhoids  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Mucositis oral  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  5/19 (26.32%) 
Nausea  1  2/3 (66.67%)  2/3 (66.67%)  3/3 (100.00%)  1/3 (33.33%)  2/6 (33.33%)  7/19 (36.84%) 
Rectal hemorrhage  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Vomiting  1  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  0/6 (0.00%)  8/19 (42.11%) 
Clostridium Difficile (C Diff)  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Cold intolerance  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Dry mouth  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/6 (0.00%)  0/19 (0.00%) 
General disorders             
Chills  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Fatigue  1  3/3 (100.00%)  3/3 (100.00%)  3/3 (100.00%)  3/3 (100.00%)  5/6 (83.33%)  18/19 (94.74%) 
Fever  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Gait disturbance  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Non-cardiac chest pain  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Pain  1  2/3 (66.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/19 (5.26%) 
Fissures  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  2/19 (10.53%) 
Decreased Appetite  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Taste changes  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Bruise at port site  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Night Sweats  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Infections and infestations             
Eye Infection  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Mucosal infection  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Papulopustular rash  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Paronychia  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  2/19 (10.53%) 
Upper Respiratory Infection  1  2/3 (66.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Reaction at port site  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Injury, poisoning and procedural complications             
Fall  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Fracture  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Investigations             
Alanine aminotransferase increased  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  4/6 (66.67%)  10/19 (52.63%) 
Alkaline phosphatase increased  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  9/19 (47.37%) 
Aspartate aminotransferase increased  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  16/19 (84.21%) 
Cholesterol high  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Creatinine increased  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  3/19 (15.79%) 
Lymphocyte count decreased  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  4/19 (21.05%) 
Weight loss  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/19 (5.26%) 
White blood cell decreased  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  8/19 (42.11%) 
Blood Bilirubin Increased  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/6 (50.00%)  13/19 (68.42%) 
Activated Partial Thromboplastin time Prolonged  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  3/19 (15.79%) 
INR Increased  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  1/19 (5.26%) 
Platelet Count Decreased  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  4/19 (21.05%) 
Neutrophil Count Decreased  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  3/19 (15.79%) 
Serum Amylase Increased  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/6 (50.00%)  0/19 (0.00%) 
Metabolism and nutrition disorders             
Anorexia  1  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  1/19 (5.26%) 
Dehydration  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Hyperglycemia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  4/6 (66.67%)  18/19 (94.74%) 
Hyperuricemia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Hypoalbuminemia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  5/6 (83.33%)  16/19 (84.21%) 
Hypocalcemia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  6/19 (31.58%) 
Hypokalemia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  8/19 (42.11%) 
Hypomagnesemia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  5/19 (26.32%) 
Hyponatremia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/6 (50.00%)  14/19 (73.68%) 
Hypophosphatemia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  3/19 (15.79%) 
Hypoglycemia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Hypernatremia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  3/6 (50.00%)  0/19 (0.00%) 
Back pain  1  2/3 (66.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Chest wall pain  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Flank Pain  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Generalized Muscle Weakness  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Joint Range of Motion Decreased  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Muscle Weakness, Left-sided  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Muscle Weakness Lower Limb  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Myalgia  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/19 (5.26%) 
Pain in Extremity  1  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Muscle spasms  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Muscle cramps  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  4/19 (21.05%) 
Tremors  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Leg and hip pain/weakness  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Nervous system disorders             
Dizziness  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Dysgeusia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Headache  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Paresthesia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Peripheral Sensory Neuropathy  1  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  3/6 (50.00%)  9/19 (47.37%) 
Seizure  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  0/19 (0.00%) 
New progressive leptomeningeal disease  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Psychiatric disorders             
Depression  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  2/3 (66.67%)  3/3 (100.00%)  2/3 (66.67%)  3/3 (100.00%)  6/6 (100.00%)  16/19 (84.21%) 
Dyspnea  1  2/3 (66.67%)  1/3 (33.33%)  1/3 (33.33%)  3/3 (100.00%)  5/6 (83.33%)  12/19 (63.16%) 
Epistaxis  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  1/19 (5.26%) 
Hoarseness  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Nasal Congestion  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/19 (5.26%) 
Sore Throat  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Erythema Multiforme  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Dry throat  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Skin and subcutaneous tissue disorders             
Alopecia  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Dry Skin  1  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  2/6 (33.33%)  1/19 (5.26%) 
Hirsutism  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/19 (5.26%) 
Pruritus  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  2/6 (33.33%)  3/19 (15.79%) 
Rash Acneiform  1  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  3/6 (50.00%)  4/19 (21.05%) 
Rash Maculo-papular  1  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  1/6 (16.67%)  4/19 (21.05%) 
Rash from cut  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Sores in mouth  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Redness on bottom lip  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/19 (0.00%) 
Social circumstances             
Menopause  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
Vascular disorders             
Hypertension  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  4/19 (21.05%) 
Thromboembolic event  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/19 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Office
Organization: Northwestern University
Phone: 312-695-1301
Layout table for additonal information
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01259089    
Other Study ID Numbers: NU 10L01
STU00038215 ( Other Identifier: Northwestern University IRB )
First Submitted: December 10, 2010
First Posted: December 13, 2010
Results First Submitted: October 22, 2018
Results First Posted: November 21, 2018
Last Update Posted: September 11, 2019