Trial Outcomes & Findings for Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors (NCT NCT01560260)
NCT ID: NCT01560260
Last Updated: 2018-09-21
Results Overview
Determine the response rate, Complete Response (CR) or Partial Response (PR), to treatment with linsitinib (OSI-906) in patients with advanced wild-type (WT) gastrointestional stromal tumor (GIST) as determined by RECIST 1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
At 6 months
Results posted on
2018-09-21
Participant Flow
Participant milestones
| Measure |
Treatment (Linsitinib)
Patients receive linsitinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Linsitinib in Treating Patients With Gastrointestinal Stromal Tumors
Baseline characteristics by cohort
| Measure |
Treatment (Linsitinib)
n=20 Participants
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: 0 out of 20 patients had a response
Determine the response rate, Complete Response (CR) or Partial Response (PR), to treatment with linsitinib (OSI-906) in patients with advanced wild-type (WT) gastrointestional stromal tumor (GIST) as determined by RECIST 1.1.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=20 Participants
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Number of Participants With Complete Response or Partial Response Using Response Evaluation Criteria in Solid Tumors Guideline Version 1.1
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsProlonged non-progression is of clinical benefit (CR + PR + SD at 9 months).
Outcome measures
| Measure |
Treatment (Linsitinib)
n=20 Participants
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Clinical Benefit Rate Defined as Stable Disease (SD) >= 9 Months, Partial Response (PR) or Complete Response (CR)
|
40 percentage of participants
|
SECONDARY outcome
Timeframe: Estimates at 9 monthsAnalyzed using Kaplan-Meier curves for the all treated and per protocol populations.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=20 Participants
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Survival (OS)
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: Time from date of enrollment to time of progression or death due to any cause, estimates at 9 monthsAnalyzed using Kaplan-Meier curves for the all treated and per protocol populations.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=20 Participants
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Progression Free Survival (PFS)
|
52 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: No responses were observed.
Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: Data was not collected for this outcome measure due to limited activity seen with the study treatment.
Analyzed using Kaplan-Meier curves for the all treated and per protocol populations
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: 285 Adverse Events reported during the study.
To determine the tolerability and adverse event profile of OSI-906 in patients with advanced GIST.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=285 Adverse Events
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Tolerability and Adverse Event Profile of Linsitinib
Related to study drug
|
101 Adverse Events
|
|
Tolerability and Adverse Event Profile of Linsitinib
Related to study drug Grade 3 or higher
|
2 Adverse Events
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: Depending on the patient samples available, the available samples varied from 17 to 14.
To explore patterns of protein expression in serum and tumor tissues as predictors of response and progression-free survival in advanced WT GIST treated with OSI-906. All Insulin Growth Factor Receptor (IGFR) and phosphorylated AKT (pAKT) evaluation was performed in a blinded manner. Distribution and intensity of positive tumor cell staining was assessed for these markers. Loss of succinate dehydrogenase complex flavoprotein subunit A (SDHA) protein expression has been correlated with the presence of a mutation in SDHA. Loss of succinate dehydrogenase complex iron sulfur subunit B (SDHB) protein expression occurs from bi-allelic inactivation of any of the succinate dehydrogenase (SDH) subunit genes. Loss of expression of one member of the complex alters the structure or production of SDH proteins such that the complex is no longer able to form. This results in elevated intracellular levels of succinate as well as loss of demethylase activity.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=17 Participants
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Patterns of Protein Expression in Serum and Tumor Tissues as Predictors of Response and PFS
SDHA deficiency
|
6 Participants
|
|
Patterns of Protein Expression in Serum and Tumor Tissues as Predictors of Response and PFS
SDHB deficiency
|
15 Participants
|
|
Patterns of Protein Expression in Serum and Tumor Tissues as Predictors of Response and PFS
High to intermediate paKT stain
|
6 Participants
|
|
Patterns of Protein Expression in Serum and Tumor Tissues as Predictors of Response and PFS
High expression of IGFR
|
10 Participants
|
|
Patterns of Protein Expression in Serum and Tumor Tissues as Predictors of Response and PFS
Intermediate levels of IGFR
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 37 weeksEvaluate the number of participants with metabolic response to OSI-906 using fluorodeoxyglucose positron emission tomography (FDG-PET). Evaluation of metabolic response to linsitinib based on two criteria (EORTC and PERCIST).
Outcome measures
| Measure |
Treatment (Linsitinib)
n=17 Participants
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Number of Participants With Metabolic Response to Linsitinib Using FDG-PET.
Partial metabolic response rate
|
2 Participants
|
|
Number of Participants With Metabolic Response to Linsitinib Using FDG-PET.
Stable disease metabolic response rate
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksTo measure changes in tumor metabolism by FDG-PET qualitatively and semi-quantitatively with SUV from baseline to first CT response evaluation and correlate the findings with size changes as defined by conventional cross-sectional imaging scans. SUVmax determined by: SUVmax = \[VOI activity (mCi/ml) \* body wt (g)\]/injected dose (mCi) SUVpeak determined by identifying the hottest cubic centimeter within a VOI centered on the lesion with the highest FDG.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=17 Participants
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Changes in Tumor Metabolism by FDG-PET Qualitatively and Semi-quantitatively With Standard Uptake Value (SUV)
SUVmax
|
19 Standard uptake value (SUV)
Interval 8.0 to 28.0
|
|
Changes in Tumor Metabolism by FDG-PET Qualitatively and Semi-quantitatively With Standard Uptake Value (SUV)
SUVpeak
|
16 Standard uptake value (SUV)
Interval 7.0 to 31.0
|
SECONDARY outcome
Timeframe: Up to 37 weeksPopulation: Data was not collected in correlation to FDG-PET response results.
To investigate correlations between glucose, insulin, tumor tissue and blood biomarkers with FDG-PET metabolic response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsTime to progression will be evaluated using cumulative incidence.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=20 Participants
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Time to Progression
|
9.1 months
Interval 1.84 to 30.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 37 weeksTo determine if the number of participants with tumor metabolic response correlates with anatomic response and clinical benefit.
Outcome measures
| Measure |
Treatment (Linsitinib)
n=17 Participants
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Determine the Number of Participants With Tumor Metabolic Response Correlating With Anatomic Response and Clinical Benefit.
Partial metabolic response
|
2 Participants
|
|
Determine the Number of Participants With Tumor Metabolic Response Correlating With Anatomic Response and Clinical Benefit.
Stable disease metabolic response
|
11 Participants
|
Adverse Events
Treatment (Linsitinib)
Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Linsitinib)
n=20 participants at risk
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal Distension - Grade 3 (Unrelated)
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain - Grade 3 (Unrelated)
|
15.0%
3/20 • Number of events 4
|
|
Gastrointestinal disorders
Constipation - Grade 2 (Unrelated)
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Edema Limbs - Grade 2 (Unlikely Related)
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Gastric Hemorrhage - Grade 3 (Unrelated)
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia - Grade 3 (Definitely Related)
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 3 (Unlikely Related)
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Lung Infection - Grade 3 (Unrelated)
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage - Grade 3 (Unrelated)
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular - Grade 3 (Unrelated)
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis - Grade 3 (Unlikely Related)
|
5.0%
1/20 • Number of events 2
|
|
Renal and urinary disorders
Renal Calculi - Grade 3 (Unrelated)
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion - Grade 2 (Unlikely Related)
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Supraventricular Tachycardia - Grade 2 (Unrelated)
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Thromboembolic event (Grade 2 - Unlikely Related)
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage - Grade 3 (Unlikely Related)
|
5.0%
1/20 • Number of events 2
|
|
Nervous system disorders
Seizure - Grade 2 (Unrelated)
|
5.0%
1/20 • Number of events 1
|
|
Surgical and medical procedures
Fistula Repair - Grade 3 (Unrelated)
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage - Grade 3 (Unrelated)
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain - Grade 3 (Unlikely Related)
|
5.0%
1/20 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Linsitinib)
n=20 participants at risk
Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Linsitinib: Given PO
Pharmacological Study: Correlative studies
|
|---|---|
|
Renal and urinary disorders
Urinary Frequency
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract Infection
|
5.0%
1/20 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
8/20 • Number of events 12
|
|
Investigations
Weight Loss
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders - Other
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Serum Amylase Increased
|
5.0%
1/20 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
5.0%
1/20 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Infection
|
10.0%
2/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Sinus Pain
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
40.0%
8/20 • Number of events 10
|
|
Investigations
Alanine Aminotransferase Increased
|
10.0%
2/20 • Number of events 3
|
|
Investigations
Alkaline Phosphatase Increased
|
10.0%
2/20 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
4/20 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
5/20 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Number of events 2
|
|
Gastrointestinal disorders
Ascites
|
10.0%
2/20 • Number of events 3
|
|
Investigations
Aspartate Aminotransferase Increased
|
10.0%
2/20 • Number of events 6
|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
15.0%
3/20 • Number of events 4
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders - Other
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Blurred Vision
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Chills
|
15.0%
3/20 • Number of events 4
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
40.0%
8/20 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 2
|
|
Investigations
Creatinine Increased
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Dental Caries
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Depression
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
8/20 • Number of events 13
|
|
Nervous system disorders
Dizziness
|
25.0%
5/20 • Number of events 6
|
|
Gastrointestinal disorders
Dry Mouth
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
15.0%
3/20 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
6/20 • Number of events 7
|
|
General disorders
Edema Limbs
|
10.0%
2/20 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Eye Disorders - Other
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fatigue
|
75.0%
15/20 • Number of events 22
|
|
General disorders
Fever
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Flu-like Symptoms
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
10.0%
2/20 • Number of events 2
|
|
General disorders
General Disorders and Administration Site Conditions - Other
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2
|
|
Hepatobiliary disorders
Hepatobiliary Disorders - Other
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
2/20 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
1/20 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
25.0%
5/20 • Number of events 5
|
|
Investigations
Investigations - Other
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Lipase Increased
|
5.0%
1/20 • Number of events 7
|
|
Nervous system disorders
Memory Impairment
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders - Other
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders - Other
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
5/20 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
65.0%
13/20 • Number of events 17
|
|
Nervous system disorders
Nervous System Disorders - Other
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Pain
|
10.0%
2/20 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
10.0%
2/20 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar Erythrodysesthesia Syndrome
|
10.0%
2/20 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
10.0%
2/20 • Number of events 2
|
|
Cardiac disorders
Paroxysmal Atrial Tachycardia
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
15.0%
3/20 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
3/20 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
15.0%
3/20 • Number of events 3
|
|
Renal and urinary disorders
Renal Colic
|
5.0%
1/20 • Number of events 1
|
Additional Information
Kristen Nuyen, Research Project Manager
Sarcoma Alliance for Research through Collaboration (SARC)
Phone: 734-930-7600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60