Trial Outcomes & Findings for Dasatinib and Erlotinib in Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00826449)

Last Updated: 2016-06-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

53 participants

Primary outcome timeframe

Baseline and at Day 21

Results posted on

2016-06-28

Participant Flow

Recruitment Period: February 6, 2008 to July 18, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Of the 53 participants registered, only 47 were eligible and treated. The study was terminated early due to futility.

Participant milestones

Participant milestones
Measure	Dasatinib + Erlotinib Dasatinib orally starting dose 70 mg/day \& Erlotinib 150 mg orally/day every 21 day cycle.
Overall Study STARTED	47
Overall Study Phase I	12
Overall Study Phase II	35
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Dasatinib + Erlotinib Dasatinib orally starting dose 70 mg/day \& Erlotinib 150 mg orally/day every 21 day cycle.
Overall Study Disease Progression	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Dasatinib and Erlotinib in Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib + Erlotinib: Phase I n=12 Participants Dasatinib orally starting dose 70 mg/day \& Erlotinib 150 mg orally/day every 21 day cycle.	Dasatinib + Erlotinib: Phase 2 n=35 Participants MTD from Phase I Dasatinib orally dose 70 mg/day \& Erlotinib 150 mg orally/day every 21 day cycle.	Total n=47 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	33 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants	63 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	17 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	18 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	29 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	35 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at Day 21

Outcome measures

Outcome measures
Measure	Dasatinib + Erlotinib n=12 Participants Dasatinib orally starting dose 70 mg/day \& Erlotinib 150 mg orally/day every 21 day cycle.
Phase I: Maximum Tolerable Dose (MTD) of Dasatinib Given With Erlotinib Hydrochloride	70 mg/day

SECONDARY outcome

Timeframe: 12 Weeks

Population: One participant only received one day of therapy therefore was not evaluable for efficacy analyses; a second participant discontinued study treatment.

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.

Outcome measures

Outcome measures
Measure	Dasatinib + Erlotinib n=33 Participants Dasatinib orally starting dose 70 mg/day \& Erlotinib 150 mg orally/day every 21 day cycle.
Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Partial Response (PR)	5 participants
Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Complete Response (CR)	0 participants
Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Progressive Disease (PD)	13 participants
Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Stable Disease (SD)	15 participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Dasatinib + Erlotinib n=33 Participants Dasatinib orally starting dose 70 mg/day \& Erlotinib 150 mg orally/day every 21 day cycle.
Phase II: Progression-Free Survival (PFS) Rate	53 Percentage of Participants

Adverse Events

Dasatinib + Erlotinib

Serious events: 3 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib + Erlotinib n=47 participants at risk Dasatinib orally starting dose 70 mg/day \& Erlotinib 150 mg orally/day every 21 day cycle.
General disorders Death	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
General disorders Multi-Organ Failure	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.

Other adverse events

Other adverse events
Measure	Dasatinib + Erlotinib n=47 participants at risk Dasatinib orally starting dose 70 mg/day \& Erlotinib 150 mg orally/day every 21 day cycle.
Gastrointestinal disorders Abdominal pain	10.6% 5/47 • Number of events 7 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Metabolism and nutrition disorders Acidosis	2.1% 1/47 • Number of events 2 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Blood and lymphatic system disorders Activated partial thromboplastin time prolonged	6.4% 3/47 • Number of events 3 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Metabolism and nutrition disorders Alanine aminotransferase increased	19.1% 9/47 • Number of events 10 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Metabolism and nutrition disorders Alkaline phosphatase increased	23.4% 11/47 • Number of events 17 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Immune system disorders Allergic rhinitis	8.5% 4/47 • Number of events 4 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Skin and subcutaneous tissue disorders Alopecia	4.3% 2/47 • Number of events 2 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Anorexia	38.3% 18/47 • Number of events 20 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Nervous system disorders Anxiety	14.9% 7/47 • Number of events 7 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Cardiac disorders Arrhythmia supraventricular	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Metabolism and nutrition disorders Aspartate aminotransferase increased	31.9% 15/47 • Number of events 23 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Ear and labyrinth disorders Auditory/Ear	4.3% 2/47 • Number of events 2 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Musculoskeletal and connective tissue disorders Back pain	8.5% 4/47 • Number of events 4 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Metabolism and nutrition disorders Bilirubin increased	8.5% 4/47 • Number of events 8 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Renal and urinary disorders Bladder hemorrhage	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Metabolism and nutrition disorders Blood glucose increased	51.1% 24/47 • Number of events 54 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Metabolism and nutrition disorders Blood uric acid increased	8.5% 4/47 • Number of events 4 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Blood and lymphatic system disorders Blood/Bone Marrow	2.1% 1/47 • Number of events 3 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Musculoskeletal and connective tissue disorders Bone pain	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Respiratory, thoracic and mediastinal disorders Bronchitis	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Cardiac disorders Cardiac General	4.3% 2/47 • Number of events 4 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Cardiac disorders Cardiac pain	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Cardiac disorders Cardiac troponin I increased	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Cardiac disorders Chest pain	10.6% 5/47 • Number of events 6 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Cardiac disorders Chest wall pain	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Blood and lymphatic system disorders Coagulation	6.4% 3/47 • Number of events 3 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Colitis	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Colitis, infectious	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Eye disorders Conjunctival disorder	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Constipation	36.2% 17/47 • Number of events 20 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
General disorders Constitutional Symptoms	4.3% 2/47 • Number of events 2 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Respiratory, thoracic and mediastinal disorders Cough	63.8% 30/47 • Number of events 34 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Metabolism and nutrition disorders Creatine phosphokinase increased	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Metabolism and nutrition disorders Creatinine increased	27.7% 13/47 • Number of events 26 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Dehydration	8.5% 4/47 • Number of events 4 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Psychiatric disorders Depression	23.4% 11/47 • Number of events 11 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Skin and subcutaneous tissue disorders Dermatology/Skin	4.3% 2/47 • Number of events 2 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Diarrhea	68.1% 32/47 • Number of events 40 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Nervous system disorders Dizziness	10.6% 5/47 • Number of events 5 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Eye disorders Dry eye syndrome	6.4% 3/47 • Number of events 3 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Dry mouth	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Skin and subcutaneous tissue disorders Dry skin	6.4% 3/47 • Number of events 3 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Dyspepsia	4.3% 2/47 • Number of events 2 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Respiratory, thoracic and mediastinal disorders Dysphagia	6.4% 3/47 • Number of events 3 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	72.3% 34/47 • Number of events 64 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
General disorders Edema limbs	19.1% 9/47 • Number of events 10 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Cardiac disorders Electrocardiogram QTc interval prolonged	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Endocrine disorders Endocrine	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Reproductive system and breast disorders Erectile dysfunction	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
General disorders Fatigue	80.9% 38/47 • Number of events 55 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Investigations Fever	12.8% 6/47 • Number of events 7 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Endocrine disorders Flushing	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Musculoskeletal and connective tissue disorders Gait abnormal	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Hepatobiliary disorders Gallbladder obstruction	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Gastritis	8.5% 4/47 • Number of events 4 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Gastrointestinal	8.5% 4/47 • Number of events 4 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Gastrointestinal pain	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
General disorders Headache	25.5% 12/47 • Number of events 13 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Ear and labyrinth disorders Hearing loss	6.4% 3/47 • Number of events 3 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Blood and lymphatic system disorders Hemoglobin decreased	72.3% 34/47 • Number of events 80 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Renal and urinary disorders Hemorrhage urinary tract	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Blood and lymphatic system disorders Hemorrhage/Bleeding	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Reproductive system and breast disorders Hot flashes	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Metabolism and nutrition disorders Hypercalcaemia	6.4% 3/47 • Number of events 3 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Cardiac disorders Hypertension	19.1% 9/47 • Number of events 9 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Endocrine disorders Hypoparathyroidism	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Cardiac disorders Hypotension	4.3% 2/47 • Number of events 2 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Endocrine disorders Hypothyroidism	4.3% 2/47 • Number of events 2 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	8.5% 4/47 • Number of events 5 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Infections and infestations Infection	6.4% 3/47 • Number of events 3 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Infections and infestations Infection (Other)	6.4% 3/47 • Number of events 3 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Blood and lymphatic system disorders INR increased	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
General disorders Insomnia	17.0% 8/47 • Number of events 8 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Musculoskeletal and connective tissue disorders Joint pain	4.3% 2/47 • Number of events 2 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Blood and lymphatic system disorders Leukopenia	8.5% 4/47 • Number of events 9 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Skin and subcutaneous tissue disorders Localized edema	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Blood and lymphatic system disorders Lymphatics	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Blood and lymphatic system disorders Lymphopenia	19.1% 9/47 • Number of events 34 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Metabolism and nutrition disorders Metabolic/Laboratory	23.4% 11/47 • Number of events 25 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Psychiatric disorders Mini mental status examination abnormal	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Mucositis oral	10.6% 5/47 • Number of events 6 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal	4.3% 2/47 • Number of events 2 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Cardiac disorders Myocardial ischemia	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Skin and subcutaneous tissue disorders Nail disorder	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Gastrointestinal disorders Nausea	63.8% 30/47 • Number of events 34 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Musculoskeletal and connective tissue disorders Neck pain	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Nervous system disorders Neurology	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Blood and lymphatic system disorders Neutrophil count decreased	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Cardiac disorders Nodal arrhythmia	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
General disorders Oral pain	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
Musculoskeletal and connective tissue disorders Osteonecrosis	2.1% 1/47 • Number of events 1 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
General disorders Pain	29.8% 14/47 • Number of events 27 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.
General disorders Pain (Other)	21.3% 10/47 • Number of events 11 • Adverse event collection was through each 3 week treatment cycle, up to 12 weeks of assessment with treatment.

Additional Information

Faye Johnson, Associate Professor, Thoracic/Head & Neck Med Oncology

University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place