Trial Outcomes & Findings for Afatinib and Paclitaxel in Patients With Advanced HER2-Positive Trastuzumab-Refractory Advanced Esophagogastric Cancer (NCT NCT01522768)
NCT ID: NCT01522768
Last Updated: 2023-11-01
Results Overview
of afatinib in patients with metastatic HER2-positive esophagogastric cancer as measured by overall clinical benefit defined as response rate (ORR) = stable disease (SD) complete response (CR) or partial response (PR) at 4 months by RECIST 1.1 criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
2 years
Results posted on
2023-11-01
Participant Flow
Participant milestones
| Measure |
Afatinib and Paclitaxel
This is a multi-institution, open-label, non-randomized, Phase II evaluation of oral afatinib daily and intravenous paclitaxel in participants with trastuzumab refractory HER2-positive metastatic or recurrent esophagogastric adenocarcinoma.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Afatinib and Paclitaxel in Patients With Advanced HER2-Positive Trastuzumab-Refractory Advanced Esophagogastric Cancer
Baseline characteristics by cohort
| Measure |
Afatinib and Paclitaxel
n=42 Participants
This is a multi-institution, open-label, non-randomized, Phase II evaluation of oral afatinib daily and intravenous paclitaxel in participants with trastuzumab refractory HER2-positive metastatic or recurrent esophagogastric adenocarcinoma.
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|---|---|
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Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsof afatinib in patients with metastatic HER2-positive esophagogastric cancer as measured by overall clinical benefit defined as response rate (ORR) = stable disease (SD) complete response (CR) or partial response (PR) at 4 months by RECIST 1.1 criteria
Outcome measures
| Measure |
Afatinib and Paclitaxel
n=42 Participants
This is a multi-institution, open-label, non-randomized, Phase II evaluation of oral afatinib daily and intravenous paclitaxel in participants with trastuzumab refractory HER2-positive metastatic or recurrent esophagogastric adenocarcinoma.
|
|---|---|
|
Efficacy
Partial Response
|
4 Participants
|
|
Efficacy
Progression of Disease
|
18 Participants
|
|
Efficacy
Stable Disease
|
12 Participants
|
|
Efficacy
Not Evaluable
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 yearsThe type, frequency, severity, timing, and relationship of each adverse event will be determined as per the NCI Common Toxicity Criteria, version 4.0.
Outcome measures
| Measure |
Afatinib and Paclitaxel
n=42 Participants
This is a multi-institution, open-label, non-randomized, Phase II evaluation of oral afatinib daily and intravenous paclitaxel in participants with trastuzumab refractory HER2-positive metastatic or recurrent esophagogastric adenocarcinoma.
|
|---|---|
|
Number of Participants Evaluated for Toxicity
|
42 Participants
|
Adverse Events
Afatinib and Paclitaxel
Serious events: 22 serious events
Other events: 41 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Afatinib and Paclitaxel
n=42 participants at risk
This is a multi-institution, open-label, non-randomized, Phase II evaluation of oral afatinib daily and intravenous paclitaxel in participants with trastuzumab refractory HER2-positive metastatic or recurrent esophagogastric adenocarcinoma.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.4%
1/42 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
6/42 • 2 years
|
|
Metabolism and nutrition disorders
Acidosis
|
4.8%
2/42 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
3/42 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/42 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
4.8%
2/42 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
12/42 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.4%
1/42 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
2.4%
1/42 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/42 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.4%
1/42 • 2 years
|
|
Nervous system disorders
Ataxia
|
4.8%
2/42 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
3/42 • 2 years
|
|
Investigations
Blood bilirubin increased
|
7.1%
3/42 • 2 years
|
|
Eye disorders
Blurred vision
|
4.8%
2/42 • 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
2.4%
1/42 • 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/42 • 2 years
|
|
Psychiatric disorders
Confusion
|
4.8%
2/42 • 2 years
|
|
Infections and infestations
Conjunctivitis
|
2.4%
1/42 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
2.4%
1/42 • 2 years
|
|
Investigations
Creatinine increased
|
2.4%
1/42 • 2 years
|
|
General disorders
Death NOS
|
4.8%
2/42 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
6/42 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
9/42 • 2 years
|
|
Nervous system disorders
Dizziness
|
4.8%
2/42 • 2 years
|
|
Gastrointestinal disorders
Dry Mouth
|
2.4%
1/42 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
3/42 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
6/42 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/42 • 2 years
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
2.4%
1/42 • 2 years
|
|
General disorders
Fatigue
|
4.8%
2/42 • 2 years
|
|
General disorders
Gait disturbance
|
2.4%
1/42 • 2 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
7.1%
3/42 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
4.8%
2/42 • 2 years
|
|
General disorders
Gen disorders & admin site conditions Other, spec
|
2.4%
1/42 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
2/42 • 2 years
|
|
Nervous system disorders
Headache
|
7.1%
3/42 • 2 years
|
|
Vascular disorders
Hematoma
|
2.4%
1/42 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.4%
1/42 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.4%
1/42 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
12/42 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.5%
4/42 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
3/42 • 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.8%
2/42 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
2/42 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
2/42 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.8%
2/42 • 2 years
|
|
Vascular disorders
Hypotension
|
2.4%
1/42 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
2/42 • 2 years
|
|
Investigations
INR increased
|
7.1%
3/42 • 2 years
|
|
Infections and infestations
Infections and infestations - Other
|
4.8%
2/42 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
11.9%
5/42 • 2 years
|
|
Nervous system disorders
Movements involuntary
|
2.4%
1/42 • 2 years
|
|
Nervous system disorders
Muscle weakness left-sided
|
2.4%
1/42 • 2 years
|
|
Nervous system disorders
Muscle weakness lower limb
|
2.4%
1/42 • 2 years
|
|
Nervous system disorders
Muscle weakness upper limb
|
2.4%
1/42 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
9.5%
4/42 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/42 • 2 years
|
|
General disorders
Pain
|
4.8%
2/42 • 2 years
|
|
Cardiac disorders
Palpitations
|
2.4%
1/42 • 2 years
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
2.4%
1/42 • 2 years
|
|
Nervous system disorders
Paresthesia
|
2.4%
1/42 • 2 years
|
|
Investigations
Platelet count decreased
|
2.4%
1/42 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/42 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.4%
1/42 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
2/42 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.4%
1/42 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
2.4%
1/42 • 2 years
|
|
Nervous system disorders
Seizure
|
2.4%
1/42 • 2 years
|
|
Infections and infestations
Sepsis
|
2.4%
1/42 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
2.4%
1/42 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
2.4%
1/42 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/42 • 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
2.4%
1/42 • 2 years
|
|
Renal and urinary disorders
Urine discoloration
|
2.4%
1/42 • 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.4%
1/42 • 2 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.4%
1/42 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
6/42 • 2 years
|
|
Investigations
Weight loss
|
2.4%
1/42 • 2 years
|
Other adverse events
| Measure |
Afatinib and Paclitaxel
n=42 participants at risk
This is a multi-institution, open-label, non-randomized, Phase II evaluation of oral afatinib daily and intravenous paclitaxel in participants with trastuzumab refractory HER2-positive metastatic or recurrent esophagogastric adenocarcinoma.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
90.5%
38/42 • 2 years
|
|
General disorders
Fatigue
|
50.0%
21/42 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
42.9%
18/42 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
31.0%
13/42 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
12/42 • 2 years
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
19.0%
8/42 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
7/42 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
7/42 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
6/42 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
6/42 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
6/42 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
11.9%
5/42 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
11.9%
5/42 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.9%
5/42 • 2 years
|
|
Investigations
White blood cell decreased
|
11.9%
5/42 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
4/42 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
4/42 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
2/42 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
9.5%
4/42 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
3/42 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
3/42 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
3/42 • 2 years
|
|
Investigations
Blood bilirubin increased
|
7.1%
3/42 • 2 years
|
|
Investigations
Creatinine increased
|
7.1%
3/42 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
7.1%
3/42 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
3/42 • 2 years
|
|
Infections and infestations
Paronychia
|
7.1%
3/42 • 2 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.8%
2/42 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
2/42 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
4.8%
2/42 • 2 years
|
|
General disorders
Edema limbs
|
4.8%
2/42 • 2 years
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
4.8%
2/42 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
2/42 • 2 years
|
|
Investigations
Platelet count decreased
|
4.8%
2/42 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
2/42 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
2/42 • 2 years
|
|
Investigations
Weight loss
|
4.8%
2/42 • 2 years
|
Additional Information
Dr. Yelena Janjigian, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place