Trial Outcomes & Findings for Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations (NCT NCT03448718)

Last Updated: 2023-11-22

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Up to a maximum of 17 months

Results posted on

2023-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Olaparib Monotherapy The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day. Olaparib: 1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olaparib Monotherapy n=19 Participants The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day. Olaparib: 1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 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	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	16 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	19 participants n=5 Participants
Prior Systemic Therapies	2 Lines of therapy n=5 Participants

PRIMARY outcome

Timeframe: Up to a maximum of 17 months

Population: Out of 19 patients, four subjects were not evaluable for best response.

Outcome measures

Outcome measures
Measure	Olaparib Monotherapy n=15 Participants The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day. Olaparib: 1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
Objective Response Rate (ORR)	0 Percentage of participants

SECONDARY outcome

Timeframe: Time of treatment start until the criteria for disease progression or death. Up to a maximum of 17 months.

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.

Outcome measures

Outcome measures
Measure	Olaparib Monotherapy n=19 Participants The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day. Olaparib: 1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
Progression-Free Survival (PFS)	1.9 Months Interval 0.8 to 16.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Time of treatment start until death or date of last contact, up to a maximum of 23 months.

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

Outcome measures

Outcome measures
Measure	Olaparib Monotherapy n=19 Participants The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day. Olaparib: 1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
Overall Survival (OS)	9.5 Months Interval 1.5 to 22.1

OTHER_PRE_SPECIFIED outcome

Timeframe: AE 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 18 months.

Number of participants with treatment related adverse events are reported by CTCAEv4 term and grade.

Outcome measures

Outcome measures
Measure	Olaparib Monotherapy n=19 Participants The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day. Olaparib: 1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
Adverse Events Platelet count decreased	3 Participants
Adverse Events Anemia	5 Participants
Adverse Events WBC count decreased	1 Participants
Adverse Events Lymphocyte count decreased	2 Participants
Adverse Events Neutrophil count decreased	2 Participants
Adverse Events Fatigue	4 Participants
Adverse Events Fever	1 Participants
Adverse Events Dizziness	1 Participants
Adverse Events Anorexia	2 Participants
Adverse Events Myalgia	1 Participants
Adverse Events Nausea	4 Participants
Adverse Events Vomiting	3 Participants
Adverse Events Diarrhea	2 Participants
Adverse Events Constipation	1 Participants
Adverse Events Abdominal pain	1 Participants
Adverse Events Allergic reaction	1 Participants
Adverse Events Confusion	1 Participants
Adverse Events Papulopustular rash	1 Participants
Adverse Events Skin disorders, other	1 Participants
Adverse Events Sore throat	1 Participants
Adverse Events Chronic kidney disease	1 Participants
Adverse Events Creatinine increased	2 Participants

Adverse Events

Olaparib Monotherapy

Serious events: 11 serious events

Other events: 18 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Olaparib Monotherapy n=19 participants at risk The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day. Olaparib: 1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
Psychiatric disorders CONFUSION	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Investigations CREATININE INCREASED	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Nervous system disorders EDEMA CEREBRAL	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
General disorders FEVER	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Respiratory, thoracic and mediastinal disorders HYPOXIA	5.3% 1/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Infections and infestations LUNG INFECTION	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
General disorders PAIN	5.3% 1/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Infections and infestations SEPSIS	5.3% 1/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Nervous system disorders STROKE	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Vascular disorders THROMBOEMBOLIC EVENT	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Infections and infestations URINARY TRACT INFECTION	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Gastrointestinal disorders VOMITING	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.

Other adverse events

Other adverse events
Measure	Olaparib Monotherapy n=19 participants at risk The starting dose of olaparib tablets will be dependent on the subject's calculated creatinine clearance (CrCl). Subjects with a CrCl of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day. Olaparib: 1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of \> 30 to \< 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
Gastrointestinal disorders ABDOMINAL PAIN	15.8% 3/19 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Investigations ALANINE AMINOTRANSFERASE INCREASED	10.5% 2/19 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Investigations ALKALINE PHOSPHATASE INCREASED	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Immune system disorders ALLERGIC REACTION	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Gastrointestinal disorders ANAL MUCOSITIS	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Blood and lymphatic system disorders ANEMIA	52.6% 10/19 • Number of events 24 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Metabolism and nutrition disorders ANOREXIA	21.1% 4/19 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Psychiatric disorders ANXIETY	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	15.8% 3/19 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Musculoskeletal and connective tissue disorders BACK PAIN	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Renal and urinary disorders BLADDER SPASM	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	5.3% 1/19 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Investigations BLOOD BILIRUBIN INCREASED	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Cardiac disorders CHEST PAIN - CARDIAC	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Investigations CHOLESTEROL HIGH	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Renal and urinary disorders CHRONIC KIDNEY DISEASE	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Psychiatric disorders CONFUSION	5.3% 1/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Gastrointestinal disorders CONSTIPATION	21.1% 4/19 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Respiratory, thoracic and mediastinal disorders COUGH	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Investigations CREATININE INCREASED	36.8% 7/19 • Number of events 16 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Psychiatric disorders DEPRESSION	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Gastrointestinal disorders DIARRHEA	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Nervous system disorders DIZZINESS	10.5% 2/19 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Gastrointestinal disorders DYSPEPSIA	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Gastrointestinal disorders DYSPHAGIA	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Respiratory, thoracic and mediastinal disorders DYSPNEA	15.8% 3/19 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
General disorders EDEMA LIMBS	10.5% 2/19 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Endocrine disorders ENDOCRINE DISORDERS - OTHER, SPECIFY	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
General disorders FACIAL PAIN	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Injury, poisoning and procedural complications FALL	10.5% 2/19 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
General disorders FATIGUE	52.6% 10/19 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
General disorders FEVER	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Musculoskeletal and connective tissue disorders FLANK PAIN	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Gastrointestinal disorders GASTROPARESIS	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	15.8% 3/19 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Nervous system disorders HEADACHE	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Vascular disorders HEMATOMA	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Renal and urinary disorders HEMATURIA	21.1% 4/19 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Metabolism and nutrition disorders HYPERGLYCEMIA	21.1% 4/19 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Metabolism and nutrition disorders HYPERKALEMIA	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Vascular disorders HYPERTENSION	15.8% 3/19 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Metabolism and nutrition disorders HYPOALBUMINEMIA	21.1% 4/19 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Metabolism and nutrition disorders HYPOCALCEMIA	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Metabolism and nutrition disorders HYPOKALEMIA	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Metabolism and nutrition disorders HYPOMAGNESEMIA	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Metabolism and nutrition disorders HYPONATREMIA	21.1% 4/19 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Vascular disorders HYPOTENSION	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Psychiatric disorders INSOMNIA	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Nervous system disorders LETHARGY	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Blood and lymphatic system disorders LEUKOCYTOSIS	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
General disorders LOCALIZED EDEMA	5.3% 1/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Investigations LYMPHOCYTE COUNT DECREASED	36.8% 7/19 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Gastrointestinal disorders MUCOSITIS ORAL	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Musculoskeletal and connective tissue disorders MYALGIA	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Gastrointestinal disorders NAUSEA	26.3% 5/19 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Investigations NEUTROPHIL COUNT DECREASED	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
General disorders PAIN	10.5% 2/19 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Infections and infestations PAPULOPUSTULAR RASH	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	10.5% 2/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Investigations PLATELET COUNT DECREASED	26.3% 5/19 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Renal and urinary disorders PROTEINURIA	15.8% 3/19 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Renal and urinary disorders RENAL AND URINARY DISORDERS - OTHER, SPECIFY	5.3% 1/19 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Reproductive system and breast disorders REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER, SPECIFY	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Cardiac disorders SINUS TACHYCARDIA	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Respiratory, thoracic and mediastinal disorders SORE THROAT	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Vascular disorders THROMBOEMBOLIC EVENT	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Infections and infestations URINARY TRACT INFECTION	15.8% 3/19 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Renal and urinary disorders URINARY TRACT OBSTRUCTION	5.3% 1/19 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Gastrointestinal disorders VOMITING	15.8% 3/19 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 months.
Investigations WHITE BLOOD CELL DECREASED	5.3% 1/19 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 23 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 18 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