Trial Outcomes & Findings for Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma (NCT NCT01488318)
NCT ID: NCT01488318
Last Updated: 2018-01-05
Results Overview
Number of patients experiencing a Complete Response (CR) + Partial Response (PR) to study treatment / Total number of evaluable patients, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to 36 months
Results posted on
2018-01-05
Participant Flow
Participant milestones
| Measure |
CETUXIMAB + DASATINIB
Cetuximab dosed at 250 mg/m\^2/week and Dasatinib dosed at 150 mg daily
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
CETUXIMAB + DASATINIB
n=14 Participants
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: Patients that received Cetuximab dosed at 250 mg/m\^2/week and Dasatinib 150 mg daily who were evaluable for response.
Number of patients experiencing a Complete Response (CR) + Partial Response (PR) to study treatment / Total number of evaluable patients, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Outcome measures
| Measure |
CETUXIMAB + DASATINIB
n=13 Participants
|
|---|---|
|
Overall Response Rate (ORR)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 36 monthsPopulation: Patients that received Cetuximab dosed at 250 mg/m\^2/week and Dasatinib 150 mg daily who were evaluable for response.
Response of evaluable patients to treatment, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Outcome measures
| Measure |
CETUXIMAB + DASATINIB
n=13 Participants
|
|---|---|
|
Response to Treatment
Patients experiencing Stable Disease (SD)
|
5 participants
|
|
Response to Treatment
Patients experiencing Progressive Disease (PD)
|
8 participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsOutcome measures
| Measure |
CETUXIMAB + DASATINIB
n=14 Participants
|
|---|---|
|
Progression-free Survival (PFS)
|
1.7 months
Interval 1.4 to 3.9
|
SECONDARY outcome
Timeframe: Up to 60 monthsFrom date of entry into the study until the date of death from any cause, assessed up to 60 months.
Outcome measures
| Measure |
CETUXIMAB + DASATINIB
n=14 Participants
|
|---|---|
|
Overall Survival (OS)
|
5.1 months
Interval 4.2 to 11.5
|
Adverse Events
CETUXIMAB + DASATINIB
Serious events: 8 serious events
Other events: 12 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
CETUXIMAB + DASATINIB
n=14 participants at risk
Cetuximab dosed at 250 mg/m\^2/week and Dasatinib dosed at 150 mg daily
|
|---|---|
|
General disorders
Edema face
|
7.1%
1/14
|
|
General disorders
Edema limbs
|
7.1%
1/14
|
|
General disorders
Fever
|
7.1%
1/14
|
|
Infections and infestations
Bronchial infection
|
7.1%
1/14
|
|
Infections and infestations
Sepsis
|
7.1%
1/14
|
|
Infections and infestations
Skin infection
|
7.1%
1/14
|
|
Infections and infestations
Soft tissue infection
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Injury to carotid artery
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
1/14
|
|
Nervous system disorders
Syncope
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
7.1%
1/14
|
|
Vascular disorders
Hypotension
|
7.1%
1/14
|
Other adverse events
| Measure |
CETUXIMAB + DASATINIB
n=14 participants at risk
Cetuximab dosed at 250 mg/m\^2/week and Dasatinib dosed at 150 mg daily
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.1%
1/14
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14
|
|
Cardiac disorders
Heart failure
|
7.1%
1/14
|
|
Ear and labyrinth disorders
Ear pain
|
7.1%
1/14
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
1/14
|
|
Eye disorders
Eye disorders - Other, specify
|
7.1%
1/14
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
1/14
|
|
Gastrointestinal disorders
Oral dysesthesia
|
7.1%
1/14
|
|
General disorders
Edema face
|
7.1%
1/14
|
|
General disorders
Facial pain
|
7.1%
1/14
|
|
General disorders
Flu like symptoms
|
7.1%
1/14
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.1%
1/14
|
|
Infections and infestations
Lung infection
|
7.1%
1/14
|
|
Infections and infestations
Mucosal infection
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Fracture
|
7.1%
1/14
|
|
Investigations
Hemoglobin increased
|
7.1%
1/14
|
|
Investigations
INR increased
|
7.1%
1/14
|
|
Investigations
Lymphocyte count increased
|
7.1%
1/14
|
|
Investigations
Weight loss
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
7.1%
1/14
|
|
Nervous system disorders
Facial nerve disorder
|
7.1%
1/14
|
|
Nervous system disorders
Lethargy
|
7.1%
1/14
|
|
Nervous system disorders
Movements involuntary
|
7.1%
1/14
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
7.1%
1/14
|
|
Nervous system disorders
Neuralgia
|
7.1%
1/14
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
1/14
|
|
Nervous system disorders
Syncope
|
7.1%
1/14
|
|
Nervous system disorders
Tremor
|
7.1%
1/14
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Body odor
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
7.1%
1/14
|
|
Vascular disorders
Lymphedema
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
14.3%
2/14
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14
|
|
General disorders
Fever
|
14.3%
2/14
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
2/14
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
2/14
|
|
Investigations
Investigations - Other, specify
|
14.3%
2/14
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
2/14
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
14.3%
2/14
|
|
Nervous system disorders
Headache
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
2/14
|
|
Vascular disorders
Hypertension
|
14.3%
2/14
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
21.4%
3/14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
21.4%
3/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
3/14
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.4%
3/14
|
|
Gastrointestinal disorders
Dry mouth
|
28.6%
4/14
|
|
Gastrointestinal disorders
Dysphagia
|
28.6%
4/14
|
|
Investigations
Platelet count decreased
|
28.6%
4/14
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
28.6%
4/14
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
4/14
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
28.6%
4/14
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
35.7%
5/14
|
|
General disorders
Fatigue
|
42.9%
6/14
|
|
General disorders
Pain
|
42.9%
6/14
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
7/14
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
7/14
|
|
Investigations
Lymphocyte count decreased
|
57.1%
8/14
|
|
Blood and lymphatic system disorders
Anemia
|
64.3%
9/14
|
Additional Information
Barbara Stadterman, Regulatory Supervisor
University of Pittsburgh Cancer Institute
Phone: 414-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place