Trial Outcomes & Findings for Image Guided Hypofractionated Radiation Therapy, Nelfinavir Mesylate, Pembrolizumab, Nivolumab and Atezolizumab in Treating Patients With Advanced Melanoma, Lung, or Kidney Cancer (NCT NCT03050060)

Last Updated: 2022-06-22

Results Overview

Will be determined by immune-related Response Evaluation Criteria in Solid Tumor 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT Scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Up to 6 months after initiating treatment

Results posted on

2022-06-22

Participant Flow

We consented 21 patients but 1 patient was not eligible. Therefore, there are only 20 patients in the number of participants.

Participant milestones

Participant milestones
Measure	Treatment (Nelfinavir, Immunotherapy, Radiation Therapy) Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution. Atezolizumab: Given IV Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Laboratory Biomarker Analysis: Correlative studies Nelfinavir Mesylate: Given PO Nivolumab: Given IV Pembrolizumab: Given IV
Overall Study STARTED	20
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Nelfinavir, Immunotherapy, Radiation Therapy) Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution. Atezolizumab: Given IV Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Laboratory Biomarker Analysis: Correlative studies Nelfinavir Mesylate: Given PO Nivolumab: Given IV Pembrolizumab: Given IV
Overall Study Adverse Event	7
Overall Study Withdrawal by Subject	1
Overall Study Progression	7

Baseline Characteristics

Image Guided Hypofractionated Radiation Therapy, Nelfinavir Mesylate, Pembrolizumab, Nivolumab and Atezolizumab in Treating Patients With Advanced Melanoma, Lung, or Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Nelfinavir, Immunotherapy, Radiation Therapy) n=20 Participants Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution. Atezolizumab: Given IV Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Laboratory Biomarker Analysis: Correlative studies Nelfinavir Mesylate: Given PO Nivolumab: Given IV Pembrolizumab: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants 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	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	2 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months after initiating treatment

Population: All patients starting trial therapy

Outcome measures

Outcome measures
Measure	Treatment (Nelfinavir, Immunotherapy, Radiation Therapy) n=17 Participants Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution. Atezolizumab: Given IV Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Laboratory Biomarker Analysis: Correlative studies Nelfinavir Mesylate: Given PO Nivolumab: Given IV Pembrolizumab: Given IV
Response Rate	2 Participants

SECONDARY outcome

Timeframe: From start of study treatment to death due to any cause, assessed up to 2 years

Population: 2 Patients were lost to follow-up before 2 year mark, 1 patient passed away during treatment due to Myocardial infarction, so they were not considered in the OS data.

Any long term data in the medical record that showed survival was use to measure overall survival.

Outcome measures

Outcome measures
Measure	Treatment (Nelfinavir, Immunotherapy, Radiation Therapy) n=17 Participants Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution. Atezolizumab: Given IV Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Laboratory Biomarker Analysis: Correlative studies Nelfinavir Mesylate: Given PO Nivolumab: Given IV Pembrolizumab: Given IV
Overall Survival OS after 2 years (Renal)	2 Participants
Overall Survival OS after 2 years (Melanoma)	3 Participants
Overall Survival Patient death occurred prior to 2 years	12 Participants

SECONDARY outcome

Timeframe: From start of treatment to progression by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, symptomatic deterioration, or death due to any cause, assessed up to 2 years

Population: 2 participants were lost to follow-up before the 2-year mark. 1 Patient passed away during treatment due to a myocardial infraction.

No RECIST measurable progression over the course of 2 years post-treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Treatment (Nelfinavir, Immunotherapy, Radiation Therapy) n=17 Participants Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution. Atezolizumab: Given IV Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Laboratory Biomarker Analysis: Correlative studies Nelfinavir Mesylate: Given PO Nivolumab: Given IV Pembrolizumab: Given IV
Progression-free Survival	2 Participants

SECONDARY outcome

Timeframe: Adverse events were assessed up to 6 months from start of study treatment and All Cause Mortality was assessed upto 2 years from start of study treatment.

Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All adverse events that were attributable to study intervention in 20 participants, and counted the frequency of severity levels in the participants.

Outcome measures

Outcome measures
Measure	Treatment (Nelfinavir, Immunotherapy, Radiation Therapy) n=83 Adverse Events Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution. Atezolizumab: Given IV Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Laboratory Biomarker Analysis: Correlative studies Nelfinavir Mesylate: Given PO Nivolumab: Given IV Pembrolizumab: Given IV
Number of Adverse Events Percentage of mild adverse events	59 Percentage of adverse events
Number of Adverse Events Percentage of Moderate Adverse Events	23 Percentage of adverse events
Number of Adverse Events Percentage of Severe Adverse Events	14.5 Percentage of adverse events
Number of Adverse Events Percentage of Life-Threatening Adverse Events	3.5 Percentage of adverse events

SECONDARY outcome

Timeframe: Up to 6 months

Population: Bio-specimens have been collected and stored, and cannot be analyzed by a processing team due to COVID-19 staffing limitations.

Changes in T-cell receptor diversity

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Nelfinavir, Immunotherapy, Radiation Therapy)

Serious events: 10 serious events

Other events: 20 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Nelfinavir, Immunotherapy, Radiation Therapy) n=20 participants at risk Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution. Atezolizumab: Given IV Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Laboratory Biomarker Analysis: Correlative studies Nelfinavir Mesylate: Given PO Nivolumab: Given IV Pembrolizumab: Given IV
Hepatobiliary disorders AST Increased	40.0% 8/20 • Number of events 8 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Hepatobiliary disorders ALT increased	50.0% 10/20 • Number of events 10 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Hepatobiliary disorders Alk phos increased	10.0% 2/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.

Other adverse events

Other adverse events
Measure	Treatment (Nelfinavir, Immunotherapy, Radiation Therapy) n=20 participants at risk Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution. Atezolizumab: Given IV Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy Laboratory Biomarker Analysis: Correlative studies Nelfinavir Mesylate: Given PO Nivolumab: Given IV Pembrolizumab: Given IV
Renal and urinary disorders Acute Kidney Injury	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Metabolism and nutrition disorders Anorexia	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Psychiatric disorders Anxiety	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Musculoskeletal and connective tissue disorders Arthritis	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Eye disorders Blurred Vision	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Cardiac disorders Bradycardia	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Psychiatric disorders Cognitive Disturbance	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Congestion	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Investigations Creatinine increase	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Skin and subcutaneous tissue disorders Dermatitis Radiaiton	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Dry cough	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Edema	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Gastrointestinal disorders Enteritis	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Eye disorders Flashing Lights	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Gastrointestinal disorders Gastritis	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Musculoskeletal and connective tissue disorders Gout	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Metabolism and nutrition disorders Hyperkalemia	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Endocrine disorders Hyperthyroidism	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Metabolism and nutrition disorders Hyponatremia	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Metabolism and nutrition disorders Insomnia	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Metabolism and nutrition disorders Loss of appetite	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Blood and lymphatic system disorders Lymphedema	5.0% 1/20 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Malaise	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Musculoskeletal and connective tissue disorders Muscle weakness	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Nervous system disorders Neuropathy	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Skin and subcutaneous tissue disorders Papulopustular rash	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Nervous system disorders Paraesthesia	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Pneumonia	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Productive Cough	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Nervous system disorders Seizure	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Sinusitis	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Investigations Lipase increase	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Investigations Increased Serum Amylase	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Sleep apnea	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Sore throat	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Ear and labyrinth disorders Vertigo	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Investigations Glucose 149	5.0% 1/20 • Number of events 1 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Investigations Increased Alkaline Phosphate	10.0% 2/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Investigations Increased Serum Bilirubin	10.0% 2/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Dehydration	10.0% 2/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Nervous system disorders Dizziness	10.0% 2/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Skin and subcutaneous tissue disorders Dry skin	10.0% 2/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Gastrointestinal disorders Dyspepsia	10.0% 2/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Fever	5.0% 1/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Hot Flashes	10.0% 2/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Skin and subcutaneous tissue disorders Pruritis	5.0% 1/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Skin and subcutaneous tissue disorders Skin Itchiness	10.0% 2/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Metabolism and nutrition disorders Weight gain	10.0% 2/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Metabolism and nutrition disorders Weight Loss	10.0% 2/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Wheezing	5.0% 1/20 • Number of events 2 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Chills	15.0% 3/20 • Number of events 3 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Investigations Hyperglycemia	15.0% 3/20 • Number of events 3 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Gastrointestinal disorders Constipation	20.0% 4/20 • Number of events 4 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Dry mouth	15.0% 3/20 • Number of events 4 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Gastrointestinal disorders Dysgeusia	15.0% 3/20 • Number of events 5 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Renal and urinary disorders Urinary frequency	20.0% 4/20 • Number of events 5 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Cough	30.0% 6/20 • Number of events 7 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 5/20 • Number of events 7 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Headache	30.0% 6/20 • Number of events 7 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Investigations Increased AST	30.0% 6/20 • Number of events 8 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Gastrointestinal disorders Vomiting	25.0% 5/20 • Number of events 9 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Investigations Increased ALT	35.0% 7/20 • Number of events 10 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Fatigue	55.0% 11/20 • Number of events 15 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Gastrointestinal disorders Nausea	50.0% 10/20 • Number of events 19 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
Gastrointestinal disorders Diarrhea	75.0% 15/20 • Number of events 24 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.
General disorders Pain	65.0% 13/20 • Number of events 39 • Adverse events are assessed during study treatment and study follow-up until the patient is removed from study (15 patients study length is 6-8 weeks, 5 patients study length 6 months.). The overall survival outcome measure data was assessed up to 2 years.

Additional Information

Dr. Ramesh Rengan, Department Chair

University of Washington

Phone: 206-598-4100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place