Trial Outcomes & Findings for Guadecitabine in Combination With Carboplatin in Extensive Stage Small Cell Lung Cancer (NCT NCT03913455)

Last Updated: 2023-12-20

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. PFS is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Time of treatment start until the criteria for disease progression or death. Up to a maximum of 7 months.

Results posted on

2023-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	Guadecitabine and Carboplatin Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Guadecitabine in Combination With Carboplatin in Extensive Stage Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guadecitabine and Carboplatin n=24 Participants Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5
Age, Continuous	62.5 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 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	24 participants n=5 Participants
Smoking Status Current	10 Participants n=5 Participants
Smoking Status Former	13 Participants n=5 Participants
Smoking Status Never	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time of treatment start until the criteria for disease progression or death. Up to a maximum of 7 months.

Population: Out of 24 subjects, 15 subjects were in Platinum Sensitive group and 9 subjects were in Platinum Resistant group.

Outcome measures

Outcome measures
Measure	Guadecitabine and Carboplatin (Platinum Sensitive) n=15 Participants Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5	Guadecitabine and Carboplatin (Platinum Resistant) n=9 Participants Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5
Progression Free Survival (PFS)	1.9 Months Interval 1.2 to 2.5	1.7 Months Interval 0.9 to 4.1

SECONDARY outcome

Timeframe: AEs had been recorded from time of signed informed consent until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 5 months

All adverse events (AEs) had been determined according to the NCI Common Terminology Criteria for (NCI CTCAE) V5. A summary of the total number of participants is provided.

Outcome measures

Outcome measures
Measure	Guadecitabine and Carboplatin (Platinum Sensitive) n=24 Participants Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5	Guadecitabine and Carboplatin (Platinum Resistant) Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5
Adverse Events	24 Participants	—

SECONDARY outcome

Timeframe: Up to a maximum of 7 months

Population: Out of 24 subjects, 15 subjects were in Platinum Sensitive group and 9 subjects were in Platinum Resistant group.

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. ORR is defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1

Outcome measures

Outcome measures
Measure	Guadecitabine and Carboplatin (Platinum Sensitive) n=15 Participants Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5	Guadecitabine and Carboplatin (Platinum Resistant) n=9 Participants Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5
Objective Response Rate (ORR)	7.1 Percentage of participants Interval 0.2 to 33.9	0 Percentage of participants No patients on Platinum Resistant group achieved confirmed CR or PR.

SECONDARY outcome

Timeframe: Up to a maximum of 7 months

Population: Out of 24 subjects, 15 subjects were in Platinum Sensitive group and 9 subjects were in Platinum Resistant group.

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. DCR defined as CR + PR + Stable Disease (SD) \>=8 weeks per RECIST 1.1

Outcome measures

Outcome measures
Measure	Guadecitabine and Carboplatin (Platinum Sensitive) n=15 Participants Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5	Guadecitabine and Carboplatin (Platinum Resistant) n=9 Participants Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5
Disease Control Rate (DCR)	42.9 Percentage of participants Interval 17.7 to 71.1	33.3 Percentage of participants Interval 7.5 to 70.1

SECONDARY outcome

Timeframe: Time of treatment start until death or date of last contact, up to a maximum of 16 months.

Population: Out of 24 subjects, 15 subjects were in Platinum Sensitive group and 9 subjects were in Platinum Resistant group.

Overall survival is defined as the time from treatment start until death or date of last contact.

Outcome measures

Outcome measures
Measure	Guadecitabine and Carboplatin (Platinum Sensitive) n=15 Participants Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5	Guadecitabine and Carboplatin (Platinum Resistant) n=9 Participants Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5
Overall Survival (OS)	6.8 Months Interval 2.7 to 10.0	4.4 Months Interval 1.4 to 11.4

Adverse Events

Guadecitabine and Carboplatin

Serious events: 6 serious events

Other events: 24 other events

Deaths: 18 deaths

Serious adverse events

Serious adverse events
Measure	Guadecitabine and Carboplatin n=24 participants at risk Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5
Musculoskeletal and connective tissue disorders BACK PAIN	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Respiratory, thoracic and mediastinal disorders DYSPNEA	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders LOWER GASTROINTESTINAL HEMORRHAGE	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Infections and infestations SEPSIS	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.

Other adverse events

Other adverse events
Measure	Guadecitabine and Carboplatin n=24 participants at risk Each cycle = 28 days; Subjects receive 4 cycles Guadecitabine: Guadecitabine 30 mg/m2 subcutaneously Days 1-5 Carboplatin: Carboplatin AUC 4 IV Day 5
Metabolism and nutrition disorders ANOREXIA	25.0% 6/24 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Psychiatric disorders ANXIETY	12.5% 3/24 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	20.8% 5/24 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Musculoskeletal and connective tissue disorders BACK PAIN	16.7% 4/24 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders BELCHING	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders BLOATING	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
General disorders PAIN	29.2% 7/24 • Number of events 16 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Investigations BLOOD BILIRUBIN INCREASED	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Investigations BLOOD PROLACTIN ABNORMAL	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Musculoskeletal and connective tissue disorders BONE PAIN	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Musculoskeletal and connective tissue disorders BUTTOCK PAIN	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Cardiac disorders CARDIAC DISORDERS - OTHER, SPECIFY	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders COLITIS	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders COLONIC ULCER	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders CONSTIPATION	33.3% 8/24 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Respiratory, thoracic and mediastinal disorders COUGH	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Metabolism and nutrition disorders DEHYDRATION	8.3% 2/24 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Nervous system disorders DEPRESSED LEVEL OF CONSCIOUSNESS	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Psychiatric disorders DEPRESSION	4.2% 1/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders DIARRHEA	20.8% 5/24 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders DRY MOUTH	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Nervous system disorders DYSGEUSIA	20.8% 5/24 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders DYSPHAGIA	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Respiratory, thoracic and mediastinal disorders DYSPNEA	29.2% 7/24 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Renal and urinary disorders DYSURIA	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Ear and labyrinth disorders EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
General disorders EDEMA LIMBS	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Endocrine disorders ENDOCRINE DISORDERS - OTHER, SPECIFY	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders ESOPHAGEAL PAIN	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Injury, poisoning and procedural complications FALL	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
General disorders FATIGUE	58.3% 14/24 • Number of events 20 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
General disorders FEVER	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	4.2% 1/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Nervous system disorders HEADACHE	12.5% 3/24 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Respiratory, thoracic and mediastinal disorders HICCUPS	4.2% 1/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Vascular disorders HOT FLASHES	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Metabolism and nutrition disorders HYPERGLYCEMIA	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Metabolism and nutrition disorders HYPERLIPIDEMIA	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Vascular disorders HYPERTENSION	4.2% 1/24 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Metabolism and nutrition disorders HYPOCALCEMIA	25.0% 6/24 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Metabolism and nutrition disorders HYPOKALEMIA	8.3% 2/24 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Metabolism and nutrition disorders HYPOMAGNESEMIA	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Metabolism and nutrition disorders HYPONATREMIA	16.7% 4/24 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Metabolism and nutrition disorders HYPOPHOSPHATEMIA	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Vascular disorders HYPOTENSION	8.3% 2/24 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
General disorders INJECTION SITE REACTION	25.0% 6/24 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Psychiatric disorders INSOMNIA	20.8% 5/24 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Blood and lymphatic system disorders LEUKOCYTOSIS	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Investigations LYMPHOCYTE COUNT DECREASED	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Nervous system disorders MEMORY IMPAIRMENT	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Musculoskeletal and connective tissue disorders MUSCLE CRAMP	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS LOWER LIMB	4.2% 1/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Musculoskeletal and connective tissue disorders MYALGIA	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders NAUSEA	41.7% 10/24 • Number of events 24 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Musculoskeletal and connective tissue disorders NECK PAIN	4.2% 1/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Investigations NEUTROPHIL COUNT DECREASED	41.7% 10/24 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
General disorders NON-CARDIAC CHEST PAIN	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Nervous system disorders PARESTHESIA	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	8.3% 2/24 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Investigations PLATELET COUNT DECREASED	16.7% 4/24 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Nervous system disorders PRESYNCOPE	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Skin and subcutaneous tissue disorders PRURITUS	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Skin and subcutaneous tissue disorders RASH ACNEIFORM	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Respiratory, thoracic and mediastinal disorders SINUS PAIN	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Cardiac disorders SINUS TACHYCARDIA	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Infections and infestations SKIN INFECTION	8.3% 2/24 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Endocrine disorders TESTOSTERONE DEFICIENCY	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Vascular disorders THROMBOEMBOLIC EVENT	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Infections and infestations THRUSH	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Infections and infestations TOOTH INFECTION	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Infections and infestations UPPER RESPIRATORY INFECTION	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Infections and infestations URINARY TRACT INFECTION	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	12.5% 3/24 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Investigations ALKALINE PHOSPHATASE INCREASED	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Skin and subcutaneous tissue disorders ALOPECIA	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Blood and lymphatic system disorders ANEMIA	50.0% 12/24 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders ABDOMINAL PAIN	20.8% 5/24 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Investigations ALANINE AMINOTRANSFERASE INCREASED	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Infections and infestations VAGINAL INFECTION	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Gastrointestinal disorders VOMITING	25.0% 6/24 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Investigations WEIGHT GAIN	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Investigations WEIGHT LOSS	20.8% 5/24 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months.
Investigations WHITE BLOOD CELL DECREASED	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 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