Trial Outcomes & Findings for Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer (NCT NCT00985192)

Last Updated: 2020-08-05

Results Overview

Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.

Results posted on

2020-08-05

Participant Flow

A total of 49 patients were enrolled between December of 2007 and November of 2009 from 18 participating sites including the University of California Los Angeles hospitals and clinics participating in the TRIO-US Network.

Participant milestones

Participant milestones
Measure	Everolimus Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis
Overall Study STARTED	49
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Everolimus Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis
Overall Study Withdrawal by Subject	1
Overall Study Disease Progression	1
Overall Study Determined to be Ineligible During Trial	2

Baseline Characteristics

Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Everolimus n=45 Participants Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Race/Ethnicity, Customized White	28 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	10 participants n=5 Participants
Race/Ethnicity, Customized Asian	4 participants n=5 Participants
Race/Ethnicity, Customized Black	3 participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants
Disease Site Gastric	21 participants n=5 Participants
Disease Site Gastroesophageal Junction	13 participants n=5 Participants
Disease Site Esophagus	11 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) score 0	15 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) score 1	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.

Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Outcome measures

Outcome measures
Measure	Everolimus n=45 Participants Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis
Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.	40 percent subjects with disease control Interval 23.0 to 54.8

SECONDARY outcome

Timeframe: 2.5 year

Overall Survival (OS), defined as the time from date of initial treatment to date of death. Survival function was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Everolimus n=45 Participants Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis
Overall Survival	3.4 months Interval 2.7 to 5.6

SECONDARY outcome

Timeframe: evry 3 months in year 1, every 6 months after that

Progression-free survival (PFS), was defined as the time from the date of initial treatment to first objective documentation of disease progression, or death. Estimated using the Kaplan-Meier method. Complete response (CR) + partial response (PR) + stable disease (SD) were determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Radiologic disease assessments were utilized.

Outcome measures

Outcome measures
Measure	Everolimus n=45 Participants Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis
Efficacy in Terms of Progression Free Response	1.8 months Interval 1.7 to 2.2

SECONDARY outcome

Timeframe: 30 months

Population: Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients. p-s6 and p-mTOR IHC expression in tumors

Potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in tumor tissue samples from these patients.

Outcome measures

Outcome measures
Measure	Everolimus n=39 Participants Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis
Observed Biomarkers Tumor Grade 0, p-S6	4 number of tissue blocks
Observed Biomarkers Tumor Grade 1+, p-S6	15 number of tissue blocks
Observed Biomarkers Tumor Grade 2+, p-S6	8 number of tissue blocks
Observed Biomarkers Tumor Grade 3+, p-S6	9 number of tissue blocks
Observed Biomarkers Tumor Grade 4+, p-S6	3 number of tissue blocks
Observed Biomarkers Tumor Grade 0, p-mTOR	0 number of tissue blocks
Observed Biomarkers Tumor Grade 1+, p-mTOR	8 number of tissue blocks
Observed Biomarkers Tumor Grade 2+, p-mTOR	22 number of tissue blocks
Observed Biomarkers Tumor Grade 3+, p-mTOR	9 number of tissue blocks
Observed Biomarkers Tumor Grade 4+, p-mTOR	0 number of tissue blocks

SECONDARY outcome

Timeframe: 30 months

Potential correlations between progression free survival and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.

Outcome measures

Outcome measures
Measure	Everolimus n=39 Participants Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis
Biomarker Correlations: Progression Free Survival p-S6 level 0-2	1.8 months Interval 1.6 to 1.9
Biomarker Correlations: Progression Free Survival p-S6 level >2	3.5 months Interval 1.9 to 3.9
Biomarker Correlations: Progression Free Survival p-mTOR level 0-2	1.8 months Interval 1.6 to 2.1
Biomarker Correlations: Progression Free Survival p-mTOR level >2	2.6 months Interval 0.7 to 3.9

SECONDARY outcome

Timeframe: 30 months

Potential correlations between time to progression and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.

Outcome measures

Outcome measures
Measure	Everolimus n=39 Participants Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis
Biomarker Correlations: Time to Progression p-S6 level 0-2	1.75 months Interval 1.6 to 1.8
Biomarker Correlations: Time to Progression p-S6 level >2	3.4 months Interval 1.9 to 3.9
Biomarker Correlations: Time to Progression p-mTOR level 0-2	1.8 months Interval 1.6 to 2.1
Biomarker Correlations: Time to Progression p-mTOR level >2	2.6 months Interval 0.7 to 3.9

Adverse Events

Everolimus

Serious events: 24 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Everolimus n=47 participants at risk Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis
Musculoskeletal and connective tissue disorders Mucositis	4.3% 2/47 • Number of events 2 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Metabolism and nutrition disorders Anorexia	10.6% 5/47 • Number of events 5 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Fatigue	19.1% 9/47 • Number of events 9 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Anemia	10.6% 5/47 • Number of events 5 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Thrombocytopenia	19.1% 9/47 • Number of events 9 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Hyperglycemia	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Hyperlipidemia	4.3% 2/47 • Number of events 2 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.

Other adverse events

Other adverse events
Measure	Everolimus n=47 participants at risk Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis
Skin and subcutaneous tissue disorders Alkaline phosphatase	6.4% 3/47 • Number of events 3 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders ALT	4.3% 2/47 • Number of events 2 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Anemia	36.2% 17/47 • Number of events 31 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Metabolism and nutrition disorders Anorexia	29.8% 14/47 • Number of events 18 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Hepatobiliary disorders AST	8.5% 4/47 • Number of events 4 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Bloating	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Respiratory, thoracic and mediastinal disorders Bronchospasm	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Cachexia	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Cardiac disorders Cardiac Infarction	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Cardiac disorders Cardiopulmonary Arrest	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Gastrointestinal disorders Constipation	8.5% 4/47 • Number of events 4 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Respiratory, thoracic and mediastinal disorders Cough	10.6% 5/47 • Number of events 5 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Dehydration	4.3% 2/47 • Number of events 4 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Gastrointestinal disorders Diarrhea	23.4% 11/47 • Number of events 11 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Skin and subcutaneous tissue disorders Distension	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Ear and labyrinth disorders Dizziness	4.3% 2/47 • Number of events 2 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Dry Mouth	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Skin and subcutaneous tissue disorders Dry skin	12.8% 6/47 • Number of events 6 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Dysphagia	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.5% 4/47 • Number of events 6 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Skin and subcutaneous tissue disorders Ecchymosis	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Skin and subcutaneous tissue disorders Edema - limb	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Fatigue	46.8% 22/47 • Number of events 39 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Infections and infestations Fever	4.3% 2/47 • Number of events 2 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Gastrointestinal disorders Flatulence	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Halitosis	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Surgical and medical procedures Hemorrhage pulmonary - nose	8.5% 4/47 • Number of events 4 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Vascular disorders Hemorrhage, GI - abdomen NOS	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Hot flashes	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Hypercholesteremia	19.1% 9/47 • Number of events 10 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Hyperglycemia	14.9% 7/47 • Number of events 13 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Hyperlipidemia	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Hypertriglyceridemia	10.6% 5/47 • Number of events 5 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Hypocalcemia	4.3% 2/47 • Number of events 3 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Hypokalemia	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Vascular disorders Hypotension	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Infections and infestations Infection - Kidney	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Infections and infestations Infection - Lung	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Infections and infestations Infection - urinary tract NOS	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Insomnia	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders LDL - elevated	8.5% 4/47 • Number of events 5 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Leukopenia	6.4% 3/47 • Number of events 5 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Lymphopenia	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Psychiatric disorders Mood alteration - anxiety	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Psychiatric disorders Mood alteration - depression	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Musculoskeletal and connective tissue disorders Mucositis - oral cavity	23.4% 11/47 • Number of events 17 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Muscle weakness - generalized	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Ear and labyrinth disorders Nasal/paranasal reactions	2.1% 1/47 • Number of events 2 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Gastrointestinal disorders Nausea	27.7% 13/47 • Number of events 15 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Neuropathy-sensory	4.3% 2/47 • Number of events 2 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Neutropenia	10.6% 5/47 • Number of events 7 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - abdomen	17.0% 8/47 • Number of events 11 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - back	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - body	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - chest/thorax NOS	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - extremity-limb	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - eye	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - head	4.3% 2/47 • Number of events 2 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - hip	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - NOS	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - oral cavity	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - shoulder	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Gastrointestinal disorders Pain - Stomach	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Nervous system disorders Pain - throat	4.3% 2/47 • Number of events 2 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Performance status decrease	12.8% 6/47 • Number of events 8 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.1% 1/47 • Number of events 3 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Skin and subcutaneous tissue disorders Pruritus	10.6% 5/47 • Number of events 5 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Skin and subcutaneous tissue disorders Rash	23.4% 11/47 • Number of events 17 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Ear and labyrinth disorders Stomatitis	4.3% 2/47 • Number of events 3 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Sweating	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Cardiac disorders Tachycardia	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Taste alteration	2.1% 1/47 • Number of events 1 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Blood and lymphatic system disorders Thrombocytopenia	38.3% 18/47 • Number of events 39 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Gastrointestinal disorders Vomiting	17.0% 8/47 • Number of events 10 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Weakness	4.3% 2/47 • Number of events 2 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
General disorders Weight loss	6.4% 3/47 • Number of events 4 • Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years. Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.

Additional Information

Dr. Zev Wainberg

UCLA GI Oncology Program, David Geffen School of Medicine at UCLA

Phone: 310 794-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place