Trial Outcomes & Findings for Azacitidine and Lintuzumab in Treating Patients With Previously Untreated Myelodysplastic Syndromes (NCT NCT00997243)

Last Updated: 2017-05-10

Results Overview

Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

up to 5 years

Results posted on

2017-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	5-azacytidine and Lintuzumab Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Overall Study STARTED	7
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	5-azacytidine and Lintuzumab Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Overall Study Early termination of study by sponsor	7

Baseline Characteristics

Azacitidine and Lintuzumab in Treating Patients With Previously Untreated Myelodysplastic Syndromes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	75 mg/m2 5-azacytidine (Vidaza, AZA) and 600 mg Lintuzumab n=7 Participants 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7 cycle 1 and all subsequent cycles. Lintuzumab 600mg as an IV infusion (flat dose for all), given on days 2, 7, 15, and 22 for cycle 1 and 600mg as an IV infusion, given every other week, twice during each cycle, including one dose given during AZA therapy for all other subsequent cycles.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	5 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Region of Enrollment United States	7 participants n=99 Participants

PRIMARY outcome

Timeframe: up to 5 years

Outcome measures

Outcome measures
Measure	5-azacytidine and Lintuzumab n=7 Participants Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Complete Response Rate	14 percentage of participants

SECONDARY outcome

Timeframe: up to 5 years

Outcome measures

Outcome measures
Measure	5-azacytidine and Lintuzumab n=7 Participants Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Overall Response Rate	14 percentage of participants

SECONDARY outcome

Timeframe: up to 5 years

All patients who received study drug were closely monitored for adverse events (AEs). All AEs that occured during study period were reported and the investigator determined the severity and relationship to study drug (unrelated, unlikely, possibly, probably, or definitely related). The NCI's CTCAE(Common Toxicity Criteria for Adverse Effects)v3.0 was used for grading AEs.

Outcome measures

Outcome measures
Measure	5-azacytidine and Lintuzumab n=7 Participants Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Toxicities of the Combination Thrombosis/embolism (vascular access-related)	14 percentage of participants
Toxicities of the Combination Platelets	100 percentage of participants
Toxicities of the Combination Neutrophils/granulocytes (ANC/AGC)	100 percentage of participants
Toxicities of the Combination Lymphopenia	57 percentage of participants
Toxicities of the Combination Leukocytes (total WBC)	100 percentage of participants
Toxicities of the Combination Infection with unknown ANC - Upper airway NOS	14 percentage of participants
Toxicities of the Combination Infection with normal ANC or Grade 1 or 2 neutroph	14 percentage of participants
Toxicities of the Combination Infection with unknown ANC - Bladder (urinary)	14 percentage of participants
Toxicities of the Combination Infection	28 percentage of participants
Toxicities of the Combination Infection Grade 3 or 4 neutrophils-blood	28 percentage of participants
Toxicities of the Combination Hemorrhage, GI (lower GI NOS/Rectum)	14 percentage of participants
Toxicities of the Combination Hemorrhage/Bleeding - Other	14 percentage of participants
Toxicities of the Combination Hemoglobin	100 percentage of participants
Toxicities of the Combination Fever (in the absence of neutropenia)	28 percentage of participants
Toxicities of the Combination Febrile neutropenia (fever of unknown origin)	14 percentage of participants

SECONDARY outcome

Timeframe: up to 5 years

Population: No participants were analyzed due to withdrawal of the investigational agent by the company.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years

Population: No participants were analyzed due to withdrawal of the investigational agent by the company.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years

Population: No participants were analyzed due to withdrawal of the investigational agent by the company.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: No participants were analyzed due to withdrawal of the investigational agent by the company.

Outcome measures

Outcome data not reported

Adverse Events

5-azacytidine and Lintuzumab

Serious events: 7 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	5-azacytidine and Lintuzumab n=7 participants at risk Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Metabolism and nutrition disorders Acidosis	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Metabolism and nutrition disorders Anorexia	57.1% 4/7 • Number of events 4 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Respiratory, thoracic and mediastinal disorders Atelectasis	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations Bilirubin (hyperbilirubinemia)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Psychiatric disorders Confusion	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Constipation	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Respiratory, thoracic and mediastinal disorders Cough	57.1% 4/7 • Number of events 4 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Hepatobiliary disorders Cystitis	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Distension/bloating, abdominal	28.6% 2/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Nervous system disorders Dizziness	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Skin and subcutaneous tissue disorders Dry skin	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	71.4% 5/7 • Number of events 6 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Edema: limb	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Fatigue (asthenia, lethargy, malaise)	57.1% 4/7 • Number of events 5 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Blood and lymphatic system disorders Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	28.6% 2/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Blood and lymphatic system disorders Hemoglobin	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Hemorrhage, GI - Lower GI NOS	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Renal and urinary disorders Hemorrhage, GU - Urinary NOS	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Vascular disorders Hemorrhage/Bleeding - Other (Specify, __)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Vascular disorders Hypotension	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Respiratory, thoracic and mediastinal disorders Hypoxia	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Infections and infestations Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Infections and infestations Infection with unknown ANC - Bladder (urinary)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations Leukocytes (total WBC)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized	28.6% 2/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Nausea	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Nervous system disorders Neurology - Other (Specify, __)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations Neutrophils/granulocytes (ANC/AGC)	42.9% 3/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Renal and urinary disorders Obstruction, GU - Bladder	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Pain - Abdomen NOS	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Pain - Back	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Renal and urinary disorders Pain - Bladder	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Cardiac disorders Pain - Cardiac/heart	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Pain - Chest wall	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Pain - Chest/thorax NOS	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Nervous system disorders Pain - Head/headache	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Pain - Joint	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Pain - Neck	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Cardiac disorders Palpitations	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Skin and subcutaneous tissue disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations Platelets	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Skin and subcutaneous tissue disorders Rash/desquamation	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Rigors/chills	42.9% 3/7 • Number of events 4 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Cardiac disorders Supraventricular and nodal arrhythmia - Sinus tachycardia	42.9% 3/7 • Number of events 5 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Cardiac disorders Supraventricular and nodal arrhythmia - Supraventricular tachycardia	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Syndromes - Other (Specify, __)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Vascular disorders Thrombosis/embolism (vascular access-related)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Renal and urinary disorders Urinary frequency/urgency	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Renal and urinary disorders Urinary retention (including neurogenic bladder)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Renal and urinary disorders Urine color change	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Eye disorders Vision-blurred vision	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Eye disorders Vision-flashing lights/floaters	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Vomiting	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).

Other adverse events

Other adverse events
Measure	5-azacytidine and Lintuzumab n=7 participants at risk Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7. Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	57.1% 4/7 • Number of events 11 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	14.3% 1/7 • Number of events 7 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	28.6% 2/7 • Number of events 9 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	14.3% 1/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Anorexia	42.9% 3/7 • Number of events 7 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Arthritis (non-septic)	14.3% 1/7 • Number of events 7 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	28.6% 2/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations Bilirubin (hyperbilirubinemia)	42.9% 3/7 • Number of events 8 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Constipation	100.0% 7/7 • Number of events 29 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Constitutional Symptoms - Other (Specify, __)	14.3% 1/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Respiratory, thoracic and mediastinal disorders Cough	57.1% 4/7 • Number of events 15 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Immune system disorders Cytokine release syndrome/acute infusion reaction	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Skin and subcutaneous tissue disorders Dermatology/Skin - Other (Specify, __)	14.3% 1/7 • Number of events 4 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Diarrhea	57.1% 4/7 • Number of events 17 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Distension/bloating, abdominal	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Nervous system disorders Dizziness	42.9% 3/7 • Number of events 8 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Skin and subcutaneous tissue disorders Dry skin	14.3% 1/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	100.0% 7/7 • Number of events 37 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Edema: head and neck	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Edema: limb	57.1% 4/7 • Number of events 33 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Fatigue (asthenia, lethargy, malaise)	100.0% 7/7 • Number of events 52 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Infections and infestations Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	28.6% 2/7 • Number of events 4 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Skin and subcutaneous tissue disorders Flushing	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	57.1% 4/7 • Number of events 5 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Vascular disorders Hematoma	14.3% 1/7 • Number of events 4 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Blood and lymphatic system disorders Hemoglobin	100.0% 7/7 • Number of events 41 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Hemorrhage, GI - Lower GI NOS	14.3% 1/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Vascular disorders Hemorrhage/Bleeding - Other	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Vascular disorders Hot flashes/flushes	14.3% 1/7 • Number of events 6 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Vascular disorders Hypotension	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Respiratory, thoracic and mediastinal disorders Hypoxia	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Incontinence, anal	14.3% 1/7 • Number of events 4 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Renal and urinary disorders Incontinence, urinary	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Infections and infestations Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Infections and infestations Infection with unknown ANC - Upper airway NOS	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations INR (International Normalized Ratio of prothrombin time)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Psychiatric disorders Insomnia	42.9% 3/7 • Number of events 25 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations Leukocytes (total WBC)	100.0% 7/7 • Number of events 31 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations Lymphopenia	57.1% 4/7 • Number of events 23 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Psychiatric disorders Mood alteration - Anxiety	28.6% 2/7 • Number of events 20 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Psychiatric disorders Mood alteration - Depression	28.6% 2/7 • Number of events 13 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Facial	14.3% 1/7 • Number of events 5 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized	28.6% 2/7 • Number of events 9 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Nausea	71.4% 5/7 • Number of events 33 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Nervous system disorders Neurology - Other (Specify, __)	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Nervous system disorders Neuropathy: sensory	14.3% 1/7 • Number of events 5 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations Neutrophils/granulocytes (ANC/AGC)	100.0% 7/7 • Number of events 33 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Eye disorders Ocular/Visual - Other (Specify, __)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Pain - Abdomen NOS	28.6% 2/7 • Number of events 4 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Pain - Back	42.9% 3/7 • Number of events 15 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Cardiac disorders Pain - Cardiac/heart	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Pain - Chest wall	14.3% 1/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Pain - Chest/thorax NOS	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	57.1% 4/7 • Number of events 17 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Eye disorders Pain - Eye	14.3% 1/7 • Number of events 5 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Nervous system disorders Pain - Head/headache	57.1% 4/7 • Number of events 22 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Pain - Joint	42.9% 3/7 • Number of events 16 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Pain - Muscle	28.6% 2/7 • Number of events 14 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Musculoskeletal and connective tissue disorders Pain - Neck	28.6% 2/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Pain - Other (Specify, __)	57.1% 4/7 • Number of events 23 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Pain - Pain NOS	28.6% 2/7 • Number of events 10 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Pain - Rectum	14.3% 1/7 • Number of events 9 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Nervous system disorders Pain - Sinus	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Respiratory, thoracic and mediastinal disorders Pain - Throat/pharynx/larynx	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Cardiac disorders Palpitations	28.6% 2/7 • Number of events 5 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Skin and subcutaneous tissue disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	28.6% 2/7 • Number of events 7 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations Platelets	100.0% 7/7 • Number of events 48 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	28.6% 2/7 • Number of events 6 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Skin and subcutaneous tissue disorders Pruritus/itching	14.3% 1/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Investigations PTT (Partial Thromboplastin Time)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Skin and subcutaneous tissue disorders Rash/desquamation	42.9% 3/7 • Number of events 13 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
General disorders Rigors/chills	57.1% 4/7 • Number of events 14 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Salivary gland changes/saliva	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	57.1% 4/7 • Number of events 12 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Cardiac disorders Supraventricular and nodal arrhythmia - Sinus tachycardia	42.9% 3/7 • Number of events 7 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Cardiac disorders Supraventricular and nodal arrhythmia - Supraventricular tachycardia	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	42.9% 3/7 • Number of events 14 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Nervous system disorders Syncope (fainting)	14.3% 1/7 • Number of events 4 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Injury, poisoning and procedural complications Thrombosis/embolism (vascular access-related)	14.3% 1/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	14.3% 1/7 • Number of events 1 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Renal and urinary disorders Urine color change	28.6% 2/7 • Number of events 6 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Eye disorders Vision-blurred vision	14.3% 1/7 • Number of events 3 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Gastrointestinal disorders Vomiting	42.9% 3/7 • Number of events 10 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Eye disorders Watery eye (epiphora, tearing)	14.3% 1/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).
Eye disorders Keratitis (corneal inflammation/corneal ulceration)	28.6% 2/7 • Number of events 2 • Reported Adverse Events (AEs) include events present at screening and after discontinuation from study (day 30).

Additional Information

Alison Walker, MD

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Phone: 614-293-3196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place