Trial Outcomes & Findings for Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma: (NCT NCT03861702)

Last Updated: 2025-04-18

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Disease Control Rate (DCR) = CR +PR+SD

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Up to 22 months

Results posted on

2025-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	FOLFOX + Irinotecan Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma:

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOLFOX + Irinotecan n=28 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	1 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 22 months

Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Disease Control Rate was defined as all participants who received at least one dose of trial drug and undergo at least one post-baseline disease assessment.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=26 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Disease Control Rate (DCR)	73 Percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: All participants who have disease assessment at 8 weeks.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=25 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Objective Response Rate (ORR) at 8 Weeks	16 Percentage of participants

SECONDARY outcome

Timeframe: 16 weeks

Population: All participants who have disease assessment at 16 weeks.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=19 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Objective Response Rate (ORR) at 16 Weeks	21 Percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Population: All participants who have disease assessment at 24 weeks.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=16 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Objective Response Rate (ORR) at 24 Weeks	25 Percentage of participants

SECONDARY outcome

Timeframe: 8 Weeks

Population: All participants who have disease assessment at 8 weeks.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=25 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Stable Disease Rate (SDR) at 8 Weeks	84 Percentage of participants

SECONDARY outcome

Timeframe: 16 Weeks

Population: All participants who have disease assessment at 16 weeks.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=19 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Stable Disease Rate (SDR) at 16 Weeks	89 Percentage of participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: All participants who have disease assessment at 24 weeks.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=15 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Stable Disease Rate (SDR) at 24 Weeks	80 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Out of 28 subjects, only 21 subjects had information for surgical resection.

Rate of resectability as determined by the proportion of subjects who undergo surgical resection of tumors.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=21 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Proportion of Subjects Able to Undergo Surgical Resection	0.095 Proportion of participants

SECONDARY outcome

Timeframe: Up to 7 months

Population: All participants who received at least one dose of trial drug, undergo at least one post-baseline disease assessment, and have post-baseline serum CA19-9 information.

A CA 19-9 test measures the amount of a protein called CA19-9 (cancer antigen 19-9) in a sample of blood. Healthy people can have small amounts of CA 19-9 in their blood. High levels of CA 19-9 are often a sign of pancreatic cancer. Increasing CA 19-9 levels mean the tumor is growing, whether decreasing CA 19-9 levels may mean the tumor is shrinking. The Mean of the percentage change from baseline in serum CA19-9 levels associated with best confirmed response (PR, SD, PD) per RECIST 1.1 are reported in the outcome measure data table.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=25 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Response of Serum CA19-9 Levels Best response: PR	-69 Percentage Change from Baseline Standard Deviation 37.41
Response of Serum CA19-9 Levels Best response: SD	-41 Percentage Change from Baseline Standard Deviation 40.87
Response of Serum CA19-9 Levels Best response: PD	31 Percentage Change from Baseline Standard Deviation 8.04

SECONDARY outcome

Timeframe: Up to 22 months

Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Progression-Free Survival was defined as all participants who received at least one dose of trial drug and either undergo at least one post-baseline disease assessment or die before any evaluation.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=26 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Progression-Free Survival (PFS)	8.1 Months Interval 5.19 to 12.1

SECONDARY outcome

Timeframe: Up to 31 months

Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint Overall Survival was defined as all participants who received at least one dose of trial drug and either undergo at least one post-baseline disease assessment or die before any evaluation.

Overall survival (OS) is defined as time from the first dose of study drug to date of death from any cause.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=26 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Overall Survival (OS)	18 Months Interval 11.3 to 22.5

SECONDARY outcome

Timeframe: Up to 7 months

Population: The analysis population for Adverse Events was defined as all patients who received at least one dose of study treatment regardless of the dosage.

Adverse events will be assessed to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=28 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Number of Participants With Adverse Events	28 Participants

SECONDARY outcome

Timeframe: Treatment Cycle 1 (14 days), Treatment Cycle 5 (70 days), Treatment Cycle 9 (126 days), Follow-Up (7 Months)

Population: All participants who reached the specified assessment time points (e.g., Cycle 9) were included in this outcome measure (Total 14 subjects). 13 out of these 14 subjects had information at treatment cycle 1, 12 out of these 14 subjects had information at treatment cycle 5, and 12 out of these 14 subjects had information at Follow-Up.

This secondary outcome measure evaluates overall quality of life using the Global Health Status scale from the EORTC QLQ-C30. Scores range from 0 to 100, with higher scores indicating better global health and quality of life. Mean (SD) scores are reported by assessment period, including only those participants who reached the defined time points (e.g., Cycle 9).

Outcome measures

Outcome measures
Measure	FOLFOX + Irinotecan n=14 Participants Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Quality of Life (QoL) Assessment: Global Health Status (EORTC QLQ-C30) Treatment Cycle 1	66.7 score on a scale Standard Deviation 26.4
Quality of Life (QoL) Assessment: Global Health Status (EORTC QLQ-C30) Treatment Cycle 5	69.4 score on a scale Standard Deviation 25.5
Quality of Life (QoL) Assessment: Global Health Status (EORTC QLQ-C30) Treatment Cycle 9	68.5 score on a scale Standard Deviation 16.7
Quality of Life (QoL) Assessment: Global Health Status (EORTC QLQ-C30) Follow-Up	76.4 score on a scale Standard Deviation 17.0

Adverse Events

FOLFOX + Irinotecan

Serious events: 15 serious events

Other events: 28 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	FOLFOX + Irinotecan n=28 participants at risk Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Gastrointestinal disorders ABDOMINAL PAIN	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Renal and urinary disorders ACUTE KIDNEY INJURY	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Investigations ALANINE AMINOTRANSFERASE INCREASED	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Infections and infestations BILIARY TRACT INFECTION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders CONSTIPATION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Metabolism and nutrition disorders DEHYDRATION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders DIARRHEA	14.3% 4/28 • Number of events 7 • Up to maximum 31 months
Gastrointestinal disorders ENTEROCOLITIS	7.1% 2/28 • Number of events 3 • Up to maximum 31 months
Infections and infestations ENTEROCOLITIS INFECTIOUS	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Infections and infestations GALLBLADDER INFECTION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders GASTRITIS	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Hepatobiliary disorders HEPATOBILIARY DISORDERS - OTHER, SPECIFY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Metabolism and nutrition disorders HYPOMAGNESEMIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Infections and infestations LUNG INFECTION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders PANCREATITIS	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Infections and infestations URINARY TRACT INFECTION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Cardiac disorders VENTRICULAR TACHYCARDIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months

Other adverse events

Other adverse events
Measure	FOLFOX + Irinotecan n=28 participants at risk Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle. FOLFOX regimen: FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil) Liposomal Irinotecan: Liposomal Irinotecan
Gastrointestinal disorders ABDOMINAL DISTENSION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders ABDOMINAL PAIN	75.0% 21/28 • Number of events 32 • Up to maximum 31 months
Renal and urinary disorders ACUTE KIDNEY INJURY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Psychiatric disorders AGITATION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Investigations ALANINE AMINOTRANSFERASE INCREASED	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Investigations ALKALINE PHOSPHATASE INCREASED	10.7% 3/28 • Number of events 3 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders ALLERGIC RHINITIS	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Skin and subcutaneous tissue disorders ALOPECIA	17.9% 5/28 • Number of events 5 • Up to maximum 31 months
Blood and lymphatic system disorders ANEMIA	32.1% 9/28 • Number of events 24 • Up to maximum 31 months
Metabolism and nutrition disorders ANOREXIA	75.0% 21/28 • Number of events 41 • Up to maximum 31 months
Nervous system disorders ANOSMIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Psychiatric disorders ANXIETY	25.0% 7/28 • Number of events 8 • Up to maximum 31 months
Musculoskeletal and connective tissue disorders ARTHRITIS	3.6% 1/28 • Number of events 2 • Up to maximum 31 months
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Cardiac disorders ATRIAL FIBRILLATION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Musculoskeletal and connective tissue disorders BACK PAIN	25.0% 7/28 • Number of events 7 • Up to maximum 31 months
Infections and infestations BACTEREMIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders BELCHING	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders BLOATING	3.6% 1/28 • Number of events 2 • Up to maximum 31 months
Investigations BLOOD BILIRUBIN INCREASED	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Eye disorders BLURRED VISION	7.1% 2/28 • Number of events 3 • Up to maximum 31 months
Musculoskeletal and connective tissue disorders BONE PAIN	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Cardiac disorders CARDIAC DISORDERS - OTHER, SPECIFY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Eye disorders CATARACT	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
General disorders CHILLS	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Investigations CHOLESTEROL HIGH	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Renal and urinary disorders CHRONIC KIDNEY DISEASE	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders COLITIS	10.7% 3/28 • Number of events 3 • Up to maximum 31 months
Psychiatric disorders CONFUSION	7.1% 2/28 • Number of events 3 • Up to maximum 31 months
Gastrointestinal disorders CONSTIPATION	60.7% 17/28 • Number of events 25 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders COUGH	14.3% 4/28 • Number of events 5 • Up to maximum 31 months
Investigations CREATININE INCREASED	3.6% 1/28 • Number of events 2 • Up to maximum 31 months
Metabolism and nutrition disorders DEHYDRATION	14.3% 4/28 • Number of events 4 • Up to maximum 31 months
Psychiatric disorders DEPRESSION	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Gastrointestinal disorders DIARRHEA	89.3% 25/28 • Number of events 74 • Up to maximum 31 months
Nervous system disorders DIZZINESS	32.1% 9/28 • Number of events 10 • Up to maximum 31 months
Eye disorders DRY EYE	3.6% 1/28 • Number of events 2 • Up to maximum 31 months
Gastrointestinal disorders DRY MOUTH	14.3% 4/28 • Number of events 5 • Up to maximum 31 months
Nervous system disorders DYSESTHESIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Nervous system disorders DYSGEUSIA	25.0% 7/28 • Number of events 7 • Up to maximum 31 months
Gastrointestinal disorders DYSPEPSIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders DYSPHAGIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders DYSPNEA	17.9% 5/28 • Number of events 5 • Up to maximum 31 months
Renal and urinary disorders DYSURIA	3.6% 1/28 • Number of events 2 • Up to maximum 31 months
Skin and subcutaneous tissue disorders ECZEMA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
General disorders EDEMA LIMBS	14.3% 4/28 • Number of events 6 • Up to maximum 31 months
Endocrine disorders ENDOCRINE DISORDERS - OTHER, SPECIFY	10.7% 3/28 • Number of events 3 • Up to maximum 31 months
Infections and infestations ENTEROCOLITIS INFECTIOUS	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders EPISTAXIS	14.3% 4/28 • Number of events 4 • Up to maximum 31 months
Reproductive system and breast disorders ERECTILE DYSFUNCTION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Eye disorders EYE DISORDERS - OTHER, SPECIFY	10.7% 3/28 • Number of events 5 • Up to maximum 31 months
Injury, poisoning and procedural complications FALL	10.7% 3/28 • Number of events 4 • Up to maximum 31 months
General disorders FATIGUE	78.6% 22/28 • Number of events 55 • Up to maximum 31 months
General disorders FEVER	10.7% 3/28 • Number of events 9 • Up to maximum 31 months
Musculoskeletal and connective tissue disorders FLANK PAIN	10.7% 3/28 • Number of events 3 • Up to maximum 31 months
Gastrointestinal disorders FLATULENCE	14.3% 4/28 • Number of events 4 • Up to maximum 31 months
Eye disorders FLOATERS	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Vascular disorders FLUSHING	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Infections and infestations FUNGEMIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Infections and infestations GALLBLADDER INFECTION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	50.0% 14/28 • Number of events 17 • Up to maximum 31 months
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	35.7% 10/28 • Number of events 11 • Up to maximum 31 months
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Nervous system disorders HEADACHE	17.9% 5/28 • Number of events 8 • Up to maximum 31 months
Cardiac disorders HEART FAILURE	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Renal and urinary disorders HEMATURIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders HEMORRHOIDS	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Infections and infestations HERPES SIMPLEX REACTIVATION	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders HICCUPS	17.9% 5/28 • Number of events 5 • Up to maximum 31 months
Metabolism and nutrition disorders HYPERGLYCEMIA	14.3% 4/28 • Number of events 8 • Up to maximum 31 months
Skin and subcutaneous tissue disorders HYPERHIDROSIS	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Metabolism and nutrition disorders HYPERKALEMIA	3.6% 1/28 • Number of events 2 • Up to maximum 31 months
Metabolism and nutrition disorders HYPERLIPIDEMIA	21.4% 6/28 • Number of events 6 • Up to maximum 31 months
Metabolism and nutrition disorders HYPERNATREMIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Vascular disorders HYPERTENSION	53.6% 15/28 • Number of events 42 • Up to maximum 31 months
Metabolism and nutrition disorders HYPOALBUMINEMIA	10.7% 3/28 • Number of events 4 • Up to maximum 31 months
Metabolism and nutrition disorders HYPOCALCEMIA	3.6% 1/28 • Number of events 6 • Up to maximum 31 months
Metabolism and nutrition disorders HYPOKALEMIA	42.9% 12/28 • Number of events 35 • Up to maximum 31 months
Metabolism and nutrition disorders HYPOMAGNESEMIA	14.3% 4/28 • Number of events 6 • Up to maximum 31 months
Metabolism and nutrition disorders HYPONATREMIA	17.9% 5/28 • Number of events 8 • Up to maximum 31 months
Metabolism and nutrition disorders HYPOPHOSPHATEMIA	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Vascular disorders HYPOTENSION	14.3% 4/28 • Number of events 6 • Up to maximum 31 months
Endocrine disorders HYPOTHYROIDISM	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Gastrointestinal disorders ILEUS	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Immune system disorders IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY	3.6% 1/28 • Number of events 3 • Up to maximum 31 months
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	7.1% 2/28 • Number of events 3 • Up to maximum 31 months
Psychiatric disorders INSOMNIA	35.7% 10/28 • Number of events 11 • Up to maximum 31 months
Investigations INVESTIGATIONS - OTHER, SPECIFY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Blood and lymphatic system disorders LEUKOCYTOSIS	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
General disorders LOCALIZED EDEMA	3.6% 1/28 • Number of events 2 • Up to maximum 31 months
Gastrointestinal disorders LOWER GASTROINTESTINAL HEMORRHAGE	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Investigations LYMPHOCYTE COUNT DECREASED	7.1% 2/28 • Number of events 6 • Up to maximum 31 months
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders MUCOSITIS ORAL	17.9% 5/28 • Number of events 8 • Up to maximum 31 months
Musculoskeletal and connective tissue disorders MUSCLE CRAMP	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	17.9% 5/28 • Number of events 6 • Up to maximum 31 months
Musculoskeletal and connective tissue disorders MYALGIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	10.7% 3/28 • Number of events 4 • Up to maximum 31 months
Gastrointestinal disorders NAUSEA	71.4% 20/28 • Number of events 59 • Up to maximum 31 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	10.7% 3/28 • Number of events 3 • Up to maximum 31 months
Investigations NEUTROPHIL COUNT DECREASED	28.6% 8/28 • Number of events 16 • Up to maximum 31 months
General disorders NON-CARDIAC CHEST PAIN	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Metabolism and nutrition disorders OBESITY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders ORAL PAIN	3.6% 1/28 • Number of events 3 • Up to maximum 31 months
General disorders PAIN	10.7% 3/28 • Number of events 6 • Up to maximum 31 months
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Nervous system disorders PARESTHESIA	42.9% 12/28 • Number of events 21 • Up to maximum 31 months
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	46.4% 13/28 • Number of events 29 • Up to maximum 31 months
Investigations PLATELET COUNT DECREASED	21.4% 6/28 • Number of events 9 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Reproductive system and breast disorders PROSTATIC OBSTRUCTION	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Psychiatric disorders PSYCHOSIS	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Nervous system disorders RADICULITIS	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders RECTAL FISSURE	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders RECTAL PAIN	3.6% 1/28 • Number of events 2 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	10.7% 3/28 • Number of events 3 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders RHINORRHEA	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Nervous system disorders SEIZURE	3.6% 1/28 • Number of events 2 • Up to maximum 31 months
Cardiac disorders SINUS BRADYCARDIA	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Skin and subcutaneous tissue disorders SKIN HYPERPIGMENTATION	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Infections and infestations SKIN INFECTION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders SLEEP APNEA	10.7% 3/28 • Number of events 3 • Up to maximum 31 months
Social circumstances SOCIAL CIRCUMSTANCES - OTHER, SPECIFY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders STRIDOR	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Surgical and medical procedures SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Nervous system disorders SYNCOPE	7.1% 2/28 • Number of events 3 • Up to maximum 31 months
Reproductive system and breast disorders TESTICULAR DISORDER	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Endocrine disorders TESTOSTERONE DEFICIENCY	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Vascular disorders THROMBOEMBOLIC EVENT	21.4% 6/28 • Number of events 6 • Up to maximum 31 months
Nervous system disorders TREMOR	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOR PAIN	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders UPPER GASTROINTESTINAL HEMORRHAGE	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Infections and infestations UPPER RESPIRATORY INFECTION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Renal and urinary disorders URINARY TRACT OBSTRUCTION	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Renal and urinary disorders URINARY TRACT PAIN	3.6% 1/28 • Number of events 2 • Up to maximum 31 months
Vascular disorders VASCULAR DISORDERS - OTHER, SPECIFY	7.1% 2/28 • Number of events 2 • Up to maximum 31 months
Ear and labyrinth disorders VERTIGO	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Gastrointestinal disorders VOMITING	50.0% 14/28 • Number of events 33 • Up to maximum 31 months
Investigations WEIGHT LOSS	35.7% 10/28 • Number of events 17 • Up to maximum 31 months
Respiratory, thoracic and mediastinal disorders WHEEZING	3.6% 1/28 • Number of events 1 • Up to maximum 31 months
Investigations WHITE BLOOD CELL DECREASED	10.7% 3/28 • Number of events 6 • Up to maximum 31 months

Additional Information

Fauzia Sharmin

Hoosier Cancer Research Network

Phone: 317-921-2050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place