Erlotinib Hydrochloride and Onalespib Lactate in Treating Patients With Recurrent or Metastatic EGFR-Mutant Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT02535338 |
Recruitment Status :
Active, not recruiting
First Posted : August 28, 2015
Results First Posted : June 22, 2022
Last Update Posted : October 12, 2022
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Recurrent Lung Non-Small Cell Carcinoma Stage IV Lung Non-Small Cell Cancer AJCC v7 |
Interventions |
Drug: Erlotinib Hydrochloride Other: Laboratory Biomarker Analysis Drug: Onalespib Lactate Other: Pharmacological Study |
Enrollment | 11 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Dose Level 1 - Onalespib IV 150 mg/m2 | Dose Level -1 - Onalespib IV 120 mg/m2 |
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Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Onalespib Lactate: Given IV Pharmacological Study: Correlative studies |
Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Onalespib Lactate: Given IV Pharmacological Study: Correlative studies |
Period Title: Overall Study | ||
Started | 3 | 8 |
Completed | 3 | 8 |
Not Completed | 0 | 0 |
Arm/Group Title | Dose Level 1 - Onalespib IV 150 mg/m2 | Dose Level -1 - Onalespib IV 120 mg/m2 | Total | |
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Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Onalespib Lactate: Given IV Pharmacological Study: Correlative studies |
Patients receive 150 mg erlotinib hydrochloride PO daily and onalespib lactate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Onalespib Lactate: Given IV Pharmacological Study: Correlative studies |
Total of all reporting groups | |
Overall Number of Baseline Participants | 3 | 8 | 11 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 3 participants | 8 participants | 11 participants | |
51
(51 to 68)
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62.5
(53 to 70)
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60
(51 to 70)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 3 participants | 8 participants | 11 participants | |
Female |
2 66.7%
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6 75.0%
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8 72.7%
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Male |
1 33.3%
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2 25.0%
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3 27.3%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 3 participants | 8 participants | 11 participants |
Caucasian |
1 33.3%
|
6 75.0%
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7 63.6%
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|
Asian |
1 33.3%
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1 12.5%
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2 18.2%
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Hispanic |
1 33.3%
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0 0.0%
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1 9.1%
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Native Hawaiian or other Pacific Islander |
0 0.0%
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1 12.5%
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1 9.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 3 participants | 8 participants | 11 participants |
3 | 8 | 11 |
Name/Title: | Paul Frankel, Ph.D. |
Organization: | City of Hope |
Phone: | 626-218-5265 |
EMail: | pfrankel@coh.org |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT02535338 |
Other Study ID Numbers: |
NCI-2015-01411 NCI-2015-01411 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) PHI-80 9878 ( Other Identifier: City of Hope Comprehensive Cancer Center LAO ) 9878 ( Other Identifier: CTEP ) N01CM00038 ( U.S. NIH Grant/Contract ) UM1CA186717 ( U.S. NIH Grant/Contract ) |
First Submitted: | August 27, 2015 |
First Posted: | August 28, 2015 |
Results First Submitted: | April 11, 2022 |
Results First Posted: | June 22, 2022 |
Last Update Posted: | October 12, 2022 |