We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Erlotinib Hydrochloride and Onalespib Lactate in Treating Patients With Recurrent or Metastatic EGFR-Mutant 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: NCT02535338
Recruitment Status : Active, not recruiting
First Posted : August 28, 2015
Results First Posted : June 22, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 8 participants 11 participants
51
(51 to 68)
62.5
(53 to 70)
60
(51 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 8 participants 11 participants
Female
2
  66.7%
6
  75.0%
8
  72.7%
Male
1
  33.3%
2
  25.0%
3
  27.3%
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%
7
  63.6%
Asian
1
  33.3%
1
  12.5%
2
  18.2%
Hispanic
1
  33.3%
0
   0.0%
1
   9.1%
Native Hawaiian or other Pacific Islander
0
   0.0%
1
  12.5%
1
   9.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 8 participants 11 participants
3 8 11
1.Primary Outcome
Title Number of Participants With at Least One Dose Limiting Toxicity (DLT)
Hide Description Adverse events were graded by CTCAE, v4. DLTs defined as ≥Gr 3 non-hematologic toxicity except nausea, vomiting, or diarrhea that could be controlled by appropriate medical intervention or prophylaxis and that resolved within 48 hours, except electrolyte toxicities that can be corrected within 48 hours. Gr 3 rash attributed to the combination was considered a DLT if it remained Gr 3 despite maximal medical management for > 72 hours. Hematologic toxicities qualifying as DLTs included febrile neutropenia; Gr 4 neutropenia for > 7 days or thrombocytopenia < 25,000/mm3 (Gr 4) if associated with a bleeding event that did not result in hemodynamic instability but required an elective platelet transfusion; or a life-threatening bleeding event that resulted in urgent intervention and admission to an intensive care unit. Delay in starting cycle 2 of ≥14 days due to toxicity related to one or more protocol drugs was also considered a DLT. The first 28-day cycle was considered the DLT period.
Time Frame 28 days from the start of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Two DLTs (Gr 3 maculopapular rash and Gr 3 hypophosphatemia) occurred at dose level 1.
Arm/Group Title Dose Level 1 - Onalespib IV 150 mg/m2 Dose Level -1 - Onalespib IV 120 mg/m2
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 3 8
Measure Type: Number
Unit of Measure: participants
2 0
2.Primary Outcome
Title Recommended Phase II Dose
Hide Description The maximum tolerated dose (MTD) of Onalespib IV in combination with 150 mg Erlotinib PO daily is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.
Time Frame 28 days from start of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Erlotinib Hydrochloride, Onalespib Lactate)
Hide Arm/Group Description:

Patients receive 150 erlotinib hydrochloride PO daily and starting dose of 150 mg/m2 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

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: mg/m2
120
3.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities.
Hide Description During the first course of therapy patients will be monitored for dose-limiting toxicities (DLT). Dose escalation will follow a 3+3 design, motivated by the desire to limit the incidence of dose-limiting toxicity to the lowest feasible levels and determine the recommended phase II dose. This outcome measure has been addressed in primary outcome measures 1 & 2.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure has been addressed in primary outcome measures 1 & 2.
Arm/Group Title Dose Level 1 - Onalespib IV 150 mg/m2 Dose Level -1 - Onalespib IV 120 mg/m2
Hide Arm/Group Description:

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 120 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

Overall Number of Participants Analyzed 3 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
  66.7%
0
   0.0%
4.Secondary Outcome
Title Number of Subject With Overall Response
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame Up to at least 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose Level 1 - Onalespib IV 150 mg/m2 Dose Level -1 - Onalespib IV 120 mg/m2
Hide Arm/Group Description:

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 120 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

Overall Number of Participants Analyzed 3 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival will be summarized as time from first protocol treatment until progression or death from any cause, using the product-limit Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame From start of treatment to time of progression or death from any cause, whichever occurs first, assessed up to at least 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The majority of patients (10/11) had lung cancers harboring EGFR ex20ins and were heavily pretreated.
Arm/Group Title Dose Level 1 - Onalespib IV 150 mg/m2 Dose Level -1 - Onalespib IV 120 mg/m2
Hide Arm/Group Description:

Patients receive 150 erlotinib hydrochloride PO daily and 150 mg/m2 of 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 120 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

Overall Number of Participants Analyzed 3 8
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(0.9 to NA)
4.5 [2] 
(1.4 to NA)
[1]
NA - The Median and upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
[2]
NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
6.Secondary Outcome
Title Number of Subject With Overall Response (Recommended Phase II Dose)
Hide Description

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI:

Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Time Frame Up to at least 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Erlotinib Hydrochloride, Onalespib Lactate)
Hide Arm/Group Description:

Patients receive 150 erlotinib hydrochloride PO daily and 120 mg/m2 of 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

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Adverse events occurred over a period of 2 years and 4 months.
Adverse Event Reporting Description "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
 
Arm/Group Title Dose Level 1 - Onalespib IV 150 mg/m2 Dose Level -1 - Onalespib IV 120 mg/m2
Hide Arm/Group Description

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

All-Cause Mortality
Dose Level 1 - Onalespib IV 150 mg/m2 Dose Level -1 - Onalespib IV 120 mg/m2
Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)      8/8 (100.00%)    
Hide Serious Adverse Events
Dose Level 1 - Onalespib IV 150 mg/m2 Dose Level -1 - Onalespib IV 120 mg/m2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/8 (37.50%)    
Gastrointestinal disorders     
Colitis * 1  1/3 (33.33%)  2 0/8 (0.00%)  0
Diarrhea * 1  1/3 (33.33%)  1 2/8 (25.00%)  2
Gastric hemorrhage * 1  1/3 (33.33%)  1 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Generalized muscle weakness * 1  1/3 (33.33%)  1 0/8 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Progressive Disease * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Nervous system disorders     
Expression aphasia * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Psychiatric disorders     
Confusion * 1  1/3 (33.33%)  1 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Skin and subcutaneous tissue disorders     
Rash maculo-papular * 1  1/3 (33.33%)  1 0/8 (0.00%)  0
1
Term from vocabulary, MedDRA (12.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Level 1 - Onalespib IV 150 mg/m2 Dose Level -1 - Onalespib IV 120 mg/m2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      8/8 (100.00%)    
Blood and lymphatic system disorders     
Anemia * 1  2/3 (66.67%)  4 8/8 (100.00%)  35
Cardiac disorders     
Sinus tachycardia * 1  0/3 (0.00%)  0 1/8 (12.50%)  2
Supraventricular tachycardia * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Ventricular tachycardia * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
tachycardia * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Gastrointestinal disorders     
Abdominal pain * 1  0/3 (0.00%)  0 5/8 (62.50%)  10
Anal hemorrhage * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Constipation * 1  1/3 (33.33%)  2 2/8 (25.00%)  3
Diarrhea * 1  3/3 (100.00%)  9 8/8 (100.00%)  60
Dry mouth * 1  0/3 (0.00%)  0 2/8 (25.00%)  2
Dyspepsia * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Dysphagia * 1  0/3 (0.00%)  0 1/8 (12.50%)  2
Gastroesophageal reflux disease * 1  1/3 (33.33%)  1 0/8 (0.00%)  0
Mucositis oral * 1  1/3 (33.33%)  1 0/8 (0.00%)  0
Nausea * 1  2/3 (66.67%)  2 4/8 (50.00%)  10
Oral pain * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Vomiting * 1  1/3 (33.33%)  1 4/8 (50.00%)  4
General disorders     
Chills * 1  1/3 (33.33%)  1 0/8 (0.00%)  0
Edema limbs * 1  1/3 (33.33%)  1 1/8 (12.50%)  1
Fatigue * 1  1/3 (33.33%)  2 6/8 (75.00%)  25
Gait disturbance * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Infusion related reaction * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Pain * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Infections and infestations     
Thrush * 1  1/3 (33.33%)  1 0/8 (0.00%)  0
Injury, poisoning and procedural complications     
Wrist fracture * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Investigations     
Activated partial thromboplastin time pr * 1  1/3 (33.33%)  2 0/8 (0.00%)  0
Alanine aminotransferase increased * 1  1/3 (33.33%)  2 1/8 (12.50%)  2
Alkaline phosphatase increased * 1  1/3 (33.33%)  2 3/8 (37.50%)  11
Aspartate aminotransferase increased * 1  1/3 (33.33%)  2 2/8 (25.00%)  4
Blood bilirubin increased * 1  0/3 (0.00%)  0 3/8 (37.50%)  9
Creatinine increased * 1  0/3 (0.00%)  0 3/8 (37.50%)  18
INR increased * 1  1/3 (33.33%)  1 0/8 (0.00%)  0
Lymphocyte count decreased * 1  2/3 (66.67%)  4 5/8 (62.50%)  18
Neutrophil count decreased * 1  0/3 (0.00%)  0 2/8 (25.00%)  2
Serum amylase increased * 1  0/3 (0.00%)  0 1/8 (12.50%)  2
Weight loss * 1  1/3 (33.33%)  1 4/8 (50.00%)  13
White blood cell decreased * 1  1/3 (33.33%)  1 2/8 (25.00%)  4
Metabolism and nutrition disorders     
Anorexia * 1  0/3 (0.00%)  0 4/8 (50.00%)  11
Dehydration * 1  0/3 (0.00%)  0 1/8 (12.50%)  3
Hypercalcemia * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Hyperglycemia * 1  0/3 (0.00%)  0 2/8 (25.00%)  5
Hyperkalemia * 1  0/3 (0.00%)  0 1/8 (12.50%)  2
Hypermagnesemia * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Hypoalbuminemia * 1  0/3 (0.00%)  0 5/8 (62.50%)  20
Hypocalcemia * 1  2/3 (66.67%)  2 2/8 (25.00%)  2
Hypoglycemia * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Hypokalemia * 1  1/3 (33.33%)  1 2/8 (25.00%)  6
Hyponatremia * 1  3/3 (100.00%)  6 5/8 (62.50%)  19
Hypophosphatemia * 1  2/3 (66.67%)  4 2/8 (25.00%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/3 (0.00%)  0 2/8 (25.00%)  5
Back pain * 1  0/3 (0.00%)  0 3/8 (37.50%)  7
Bone pain * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Chest wall pain * 1  0/3 (0.00%)  0 1/8 (12.50%)  4
Generalized muscle weakness * 1  0/3 (0.00%)  0 2/8 (25.00%)  2
Hand shaking * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Myalgia * 1  0/3 (0.00%)  0 2/8 (25.00%)  2
Pain in extremity * 1  0/3 (0.00%)  0 2/8 (25.00%)  3
cramps * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
left shoulder pain * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
muscle cramps * 1  1/3 (33.33%)  1 0/8 (0.00%)  0
Nervous system disorders     
Dizziness * 1  1/3 (33.33%)  1 3/8 (37.50%)  3
Dysgeusia * 1  0/3 (0.00%)  0 2/8 (25.00%)  3
Headache * 1  0/3 (0.00%)  0 2/8 (25.00%)  5
Memory impairment * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Paresthesia * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Presyncope * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Syncope * 1  0/3 (0.00%)  0 1/8 (12.50%)  2
Psychiatric disorders     
Anxiety * 1  1/3 (33.33%)  1 0/8 (0.00%)  0
Confusion * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Depression * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Insomnia * 1  0/3 (0.00%)  0 2/8 (25.00%)  2
Renal and urinary disorders     
Renal calculi * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Urinary frequency * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Urinary tract pain * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Cough * 1  1/3 (33.33%)  1 1/8 (12.50%)  1
Dyspnea * 1  1/3 (33.33%)  1 2/8 (25.00%)  5
Hoarseness * 1  0/3 (0.00%)  0 1/8 (12.50%)  3
Laryngeal hemorrhage * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Rhinorrhea * 1  0/3 (0.00%)  0 1/8 (12.50%)  2
thoracic area * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Skin and subcutaneous tissue disorders     
Alopecia * 1  0/3 (0.00%)  0 2/8 (25.00%)  3
Dry skin * 1  0/3 (0.00%)  0 5/8 (62.50%)  11
Exfoliating skin * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Nail cracking * 1  0/3 (0.00%)  0 1/8 (12.50%)  2
Rash acneiform * 1  1/3 (33.33%)  1 4/8 (50.00%)  17
Rash maculo-papular * 1  1/3 (33.33%)  1 2/8 (25.00%)  5
cold sore * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
nail changes * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
port site skin irritation * 1  0/3 (0.00%)  0 1/8 (12.50%)  1
Vascular disorders     
Flushing * 1  0/3 (0.00%)  0 1/8 (12.50%)  2
Hypertension * 1  0/3 (0.00%)  0 3/8 (37.50%)  12
1
Term from vocabulary, MedDRA (12.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Paul Frankel, Ph.D.
Organization: City of Hope
Phone: 626-218-5265
EMail: pfrankel@coh.org
Layout table for additonal information
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