Trial Outcomes & Findings for S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor (NCT NCT00068367)
NCT ID: NCT00068367
Last Updated: 2017-11-06
Results Overview
Complete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
25 weeks
Results posted on
2017-11-06
Participant Flow
Four patients enrolled to study were found to be ineligible. One patient did not have measurable disease, one patient had radiotherapy 19 days prior to registration and two patients were found ineligible upon pathology review.
Participant milestones
| Measure |
Arm I (OSI-774)
OSI-774 150 mg daily for 25 weeks
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor
Baseline characteristics by cohort
| Measure |
Arm I (OSI-774)
n=20 Participants
OSI-774 150 mg daily for 25 weeks
|
|---|---|
|
Age, Continuous
|
45.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Prior multi-agent chemotherapy
Yes
|
14 Participants
n=5 Participants
|
|
Prior multi-agent chemotherapy
No
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 25 weeksComplete response - Complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial response - Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease, no new lesions.
Outcome measures
| Measure |
Arm I (OSI-774)
n=20 Participants
OSI-774 150 mg daily for 25 weeks
|
|---|---|
|
Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 25 weeksPopulation: All participants receiving at least some protocol treatment
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Arm I (OSI-774)
n=20 Participants
OSI-774 150 mg daily for 25 weeks
|
|---|---|
|
Toxicity
Anorexia
|
1 Participants
|
|
Toxicity
Pain - Abdomen NOS
|
1 Participants
|
|
Toxicity
Diarrhea
|
1 Participants
|
|
Toxicity
Dyspnea (shortness of breath)
|
1 Participants
|
|
Toxicity
Fatigue (asthenia, lethargy, malaise)
|
3 Participants
|
|
Toxicity
Hemoglobin
|
1 Participants
|
|
Toxicity
Nausea
|
1 Participants
|
|
Toxicity
Pruritus/itching
|
1 Participants
|
|
Toxicity
Rash/desquamation
|
1 Participants
|
|
Toxicity
Somnolence/depressed level of consciousness
|
1 Participants
|
|
Toxicity
Vision-blurred vision
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
NOT COMPLETED DUE TO EARLY CLOSURE OF STUDY
Outcome measures
Outcome data not reported
Adverse Events
Arm I (OSI-774)
Serious events: 12 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (OSI-774)
n=20 participants at risk
OSI-774 150 mg daily for 25 weeks
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Up to 25 weeks
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
5.0%
1/20 • Up to 25 weeks
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
5.0%
1/20 • Up to 25 weeks
|
|
General disorders
Pain - Chest/thorax NOS
|
10.0%
2/20 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
5.0%
1/20 • Up to 25 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
45.0%
9/20 • Up to 25 weeks
|
|
Nervous system disorders
Pain - Neuralgia/peripheral nerve
|
5.0%
1/20 • Up to 25 weeks
|
|
Nervous system disorders
Syncope (fainting)
|
5.0%
1/20 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.0%
2/20 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • Up to 25 weeks
|
Other adverse events
| Measure |
Arm I (OSI-774)
n=20 participants at risk
OSI-774 150 mg daily for 25 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
10.0%
2/20 • Up to 25 weeks
|
|
Eye disorders
Dry eye syndrome
|
5.0%
1/20 • Up to 25 weeks
|
|
Eye disorders
Ocular/Visual-Other
|
10.0%
2/20 • Up to 25 weeks
|
|
Eye disorders
Vision-blurred vision
|
5.0%
1/20 • Up to 25 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Up to 25 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
35.0%
7/20 • Up to 25 weeks
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
5.0%
1/20 • Up to 25 weeks
|
|
Gastrointestinal disorders
Hemorrhage, GI - Oral cavity
|
5.0%
1/20 • Up to 25 weeks
|
|
Gastrointestinal disorders
Hemorrhage, GI - Upper GI NOS
|
5.0%
1/20 • Up to 25 weeks
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
10.0%
2/20 • Up to 25 weeks
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
5.0%
1/20 • Up to 25 weeks
|
|
Gastrointestinal disorders
Nausea
|
30.0%
6/20 • Up to 25 weeks
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
10.0%
2/20 • Up to 25 weeks
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • Up to 25 weeks
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
5.0%
1/20 • Up to 25 weeks
|
|
General disorders
Edema: head and neck
|
5.0%
1/20 • Up to 25 weeks
|
|
General disorders
Edema: limb
|
10.0%
2/20 • Up to 25 weeks
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
45.0%
9/20 • Up to 25 weeks
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
10.0%
2/20 • Up to 25 weeks
|
|
General disorders
Pain - Chest/thorax NOS
|
5.0%
1/20 • Up to 25 weeks
|
|
General disorders
Pain-Other
|
5.0%
1/20 • Up to 25 weeks
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus
|
5.0%
1/20 • Up to 25 weeks
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - UTI
|
5.0%
1/20 • Up to 25 weeks
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
5.0%
1/20 • Up to 25 weeks
|
|
Investigations
Alkaline phosphatase
|
5.0%
1/20 • Up to 25 weeks
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
10.0%
2/20 • Up to 25 weeks
|
|
Investigations
Leukocytes (total WBC)
|
5.0%
1/20 • Up to 25 weeks
|
|
Investigations
Lymphopenia
|
10.0%
2/20 • Up to 25 weeks
|
|
Investigations
Weight loss
|
10.0%
2/20 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
35.0%
7/20 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
5.0%
1/20 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
5.0%
1/20 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
5.0%
1/20 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
10.0%
2/20 • Up to 25 weeks
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
5.0%
1/20 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
15.0%
3/20 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
5.0%
1/20 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
5.0%
1/20 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
5.0%
1/20 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
5.0%
1/20 • Up to 25 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
30.0%
6/20 • Up to 25 weeks
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Up to 25 weeks
|
|
Nervous system disorders
Leak, cerebrospinal fluid (CSF)
|
5.0%
1/20 • Up to 25 weeks
|
|
Nervous system disorders
Neuropathy: sensory
|
5.0%
1/20 • Up to 25 weeks
|
|
Nervous system disorders
Ocular/Visual-Other
|
10.0%
2/20 • Up to 25 weeks
|
|
Nervous system disorders
Pain - Head/headache
|
20.0%
4/20 • Up to 25 weeks
|
|
Nervous system disorders
Pain - Neuralgia/peripheral nerve
|
5.0%
1/20 • Up to 25 weeks
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
5.0%
1/20 • Up to 25 weeks
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Up to 25 weeks
|
|
Psychiatric disorders
Mood alteration - depression
|
5.0%
1/20 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
1/20 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
6/20 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
40.0%
8/20 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.0%
1/20 • Up to 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other
|
5.0%
1/20 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
4/20 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
20.0%
4/20 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
15.0%
3/20 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
80.0%
16/20 • Up to 25 weeks
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
5.0%
1/20 • Up to 25 weeks
|
|
Vascular disorders
Hemorrhage/Bleeding-Other
|
10.0%
2/20 • Up to 25 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60