Trial Outcomes & Findings for Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases (NCT NCT02582749)

NCT ID: NCT02582749

Last Updated: 2022-07-11

Results Overview

rPFS assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) to compare outcomes of subjects on experimental arm vs control arm

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: From date of randomization to disease progression or death from any cause, up to a maximum of 24 months.
• Results posted on: 2022-07-11

Participant Flow

Participant milestones

Measure	Control Arm A All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle. Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.	Experimental Arm B All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. Radium-223 dichloride, 50 kBq/kg body weight, will be administered as a bolus intravenous (IV) injection at intervals of every 28 days for up to 6 cycles. LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle. Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle. Radium-223 dichloride: Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections
Overall Study STARTED	5	11
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	11

Reasons for withdrawal

Measure	Control Arm A All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle. Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.	Experimental Arm B All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. Radium-223 dichloride, 50 kBq/kg body weight, will be administered as a bolus intravenous (IV) injection at intervals of every 28 days for up to 6 cycles. LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle. Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle. Radium-223 dichloride: Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections
Overall Study Study terminated by funder	5	10
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases

Baseline characteristics by cohort

Measure	Control Arm A n=5 Participants All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle. Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.	Experimental Arm B n=11 Participants All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. Radium-223 dichloride, 50 kBq/kg body weight, will be administered as a bolus intravenous (IV) injection at intervals of every 28 days for up to 6 cycles. LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle. Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle. Radium-223 dichloride: Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	11 participants n=7 Participants	16 participants n=5 Participants
Extent of Disease <6 skel met, no visc met, total alk phos<=130 IU/L	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Extent of Disease <6 skel met, no visc met, total alk phos >130IU/L	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Extent of Disease >=6 skel met or visc met, total alk phos <=130IU/L	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Extent of Disease >=6 skel met or visc met, total alk phos >130IU/L	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization to disease progression or death from any cause, up to a maximum of 24 months.

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

rPFS assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) to compare outcomes of subjects on experimental arm vs control arm

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

The intensity of AEs for subjects on both arms graded according to CTCAE v4.0 on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

SRE of subjects on both arms assessed by bone scan or axial imaging

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

Secondary neoplasms of subjects on both arms assessed by bone scan or axial imaging

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose of androgen deprivation therapy (ADT) until completion of 7 cycles (28 weeks)

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

Subjects on both arms with PSA ≤ 0.2 ng/mL after 7 months of androgen deprivation therapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose of ADT until completion of 7 cycles (28 weeks)

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

Subjects on both arms with PSA between 0.2 and ≤ 4 ng/mL after 7 months of androgen deprivation therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of ADT (first LHRH agonist/antagonist/surgical castration) to date of PSA and/or radiographic progression, assessed for a maximum of 24 months

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

Castration resistance for subjects on both arms determined by first PSA level increase and/or radiographic progression by first imaging assessment showing progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization to first occurrence of PSA progression, symptomatic deterioration, or death due to any cause, assessed up to 24 months

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

PSA PFS for subjects on both arms defined as first PSA level increase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization to death from any cause, assessed up to 24 months

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

OS for subjects on both arms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization until completion of 12 weeks of therapy

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

ALP normalization for subjects with abnormal ALP at randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of randomization until date of ALP progression, assessed up to 24 months

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

ALP progression of 25% or greater from baseline/nadir for subjects on both arms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline until 30 days after the last treatment, assessed for a maximum of 24 months

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

Subjects on both arms self-reported evaluation of worst pain item, as well as the subscale scores for pain severity and pain interference as determined by subject responses on the BPI-SF questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline until 30 days after the last treatment, assessed for a maximum of 24 months

Population: Data was not collected or analyzed for this objective due to the termination of the study by the funder

Analgesic use scores for subjects on both arms will be assigned by the treating physician based on the subject's daily analgesic use on average. A single numeric score (0, 1, 2 or 3) will be assigned based on the 3-step WHO pain ladder.

Outcome measures

Outcome data not reported

Adverse Events

Control Arm A

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Experimental Arm B

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control Arm A n=5 participants at risk All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle. Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.	Experimental Arm B n=11 participants at risk All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. Radium-223 dichloride, 50 kBq/kg body weight, will be administered as a bolus intravenous (IV) injection at intervals of every 28 days for up to 6 cycles. LHRH agonist/antagonist: Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle. Bicalutamide: Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle. Radium-223 dichloride: Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections
Gastrointestinal disorders ABDOMINAL PAIN	20.0% 1/5 • Number of events 2 • Duration of participation in study, until study termination.	18.2% 2/11 • Number of events 2 • Duration of participation in study, until study termination.
Investigations ALKALINE PHOSPHATASE INCREASED	20.0% 1/5 • Number of events 2 • Duration of participation in study, until study termination.	18.2% 2/11 • Number of events 2 • Duration of participation in study, until study termination.
Blood and lymphatic system disorders ANEMIA	40.0% 2/5 • Number of events 2 • Duration of participation in study, until study termination.	45.5% 5/11 • Number of events 8 • Duration of participation in study, until study termination.
Musculoskeletal and connective tissue disorders ARTHRALGIA	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	0.00% 0/11 • Duration of participation in study, until study termination.
Musculoskeletal and connective tissue disorders BACK PAIN	40.0% 2/5 • Number of events 2 • Duration of participation in study, until study termination.	27.3% 3/11 • Number of events 4 • Duration of participation in study, until study termination.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Gastrointestinal disorders CONSTIPATION	60.0% 3/5 • Number of events 4 • Duration of participation in study, until study termination.	36.4% 4/11 • Number of events 4 • Duration of participation in study, until study termination.
Psychiatric disorders DEPRESSION	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Respiratory, thoracic and mediastinal disorders DYSPNEA	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	18.2% 2/11 • Number of events 2 • Duration of participation in study, until study termination.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Injury, poisoning and procedural complications FALL	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	0.00% 0/11 • Duration of participation in study, until study termination.
General disorders FATIGUE	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	63.6% 7/11 • Number of events 12 • Duration of participation in study, until study termination.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	0.00% 0/11 • Duration of participation in study, until study termination.
Nervous system disorders HEADACHE	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 2 • Duration of participation in study, until study termination.
Vascular disorders HOT FLASHES	40.0% 2/5 • Number of events 3 • Duration of participation in study, until study termination.	72.7% 8/11 • Number of events 8 • Duration of participation in study, until study termination.
Metabolism and nutrition disorders HYPERGLYCEMIA	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	36.4% 4/11 • Number of events 13 • Duration of participation in study, until study termination.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	20.0% 1/5 • Number of events 3 • Duration of participation in study, until study termination.	0.00% 0/11 • Duration of participation in study, until study termination.
Vascular disorders HYPERTENSION	80.0% 4/5 • Number of events 4 • Duration of participation in study, until study termination.	63.6% 7/11 • Number of events 12 • Duration of participation in study, until study termination.
Psychiatric disorders INSOMNIA	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	0.00% 0/11 • Duration of participation in study, until study termination.
Musculoskeletal and connective tissue disorders MYALGIA	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	0.00% 0/11 • Duration of participation in study, until study termination.
Gastrointestinal disorders NAUSEA	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	36.4% 4/11 • Number of events 5 • Duration of participation in study, until study termination.
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
General disorders PAIN	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	27.3% 3/11 • Number of events 4 • Duration of participation in study, until study termination.
Nervous system disorders SPASTICITY	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	0.00% 0/11 • Duration of participation in study, until study termination.
Renal and urinary disorders URINARY INCONTINENCE	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	0.00% 0/11 • Duration of participation in study, until study termination.
Renal and urinary disorders URINARY RETENTION	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Infections and infestations URINARY TRACT INFECTION	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	0.00% 0/11 • Duration of participation in study, until study termination.
Renal and urinary disorders URINARY URGENCY	20.0% 1/5 • Number of events 1 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Psychiatric disorders AGITATION	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/5 • Duration of participation in study, until study termination.	27.3% 3/11 • Number of events 5 • Duration of participation in study, until study termination.
Nervous system disorders AMNESIA	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Metabolism and nutrition disorders ANOREXIA	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Psychiatric disorders ANORGASMIA	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Psychiatric disorders ANXIETY	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/5 • Duration of participation in study, until study termination.	27.3% 3/11 • Number of events 4 • Duration of participation in study, until study termination.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/5 • Duration of participation in study, until study termination.	27.3% 3/11 • Number of events 4 • Duration of participation in study, until study termination.
Investigations CHOLESTEROL HIGH	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Gastrointestinal disorders DIARRHEA	0.00% 0/5 • Duration of participation in study, until study termination.	36.4% 4/11 • Number of events 8 • Duration of participation in study, until study termination.
Nervous system disorders DIZZINESS	0.00% 0/5 • Duration of participation in study, until study termination.	27.3% 3/11 • Number of events 4 • Duration of participation in study, until study termination.
General disorders EDEMA LIMBS	0.00% 0/5 • Duration of participation in study, until study termination.	18.2% 2/11 • Number of events 3 • Duration of participation in study, until study termination.
Eye disorders EYE DISORDERS - OTHER, SPECIFY	0.00% 0/5 • Duration of participation in study, until study termination.	36.4% 4/11 • Number of events 4 • Duration of participation in study, until study termination.
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Vascular disorders FLUSHING	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Reproductive system and breast disorders GYNECOMASTIA	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Ear and labyrinth disorders HEARING IMPAIRED	0.00% 0/5 • Duration of participation in study, until study termination.	18.2% 2/11 • Number of events 2 • Duration of participation in study, until study termination.
Renal and urinary disorders HEMATURIA	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Injury, poisoning and procedural complications INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Investigations INVESTIGATIONS - OTHER, SPECIFY	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Psychiatric disorders LIBIDO DECREASED	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Investigations LYMPHOCYTE COUNT DECREASED	0.00% 0/5 • Duration of participation in study, until study termination.	18.2% 2/11 • Number of events 2 • Duration of participation in study, until study termination.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/5 • Duration of participation in study, until study termination.	18.2% 2/11 • Number of events 5 • Duration of participation in study, until study termination.
Nervous system disorders PARESTHESIA	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Reproductive system and breast disorders PELVIC PAIN	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Investigations PLATELET COUNT DECREASED	0.00% 0/5 • Duration of participation in study, until study termination.	18.2% 2/11 • Number of events 5 • Duration of participation in study, until study termination.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Psychiatric disorders PSYCHIATRIC DISORDERS - OTHER, SPECIFY	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Renal and urinary disorders RENAL AND URINARY DISORDERS - OTHER, SPECIFY	0.00% 0/5 • Duration of participation in study, until study termination.	36.4% 4/11 • Number of events 4 • Duration of participation in study, until study termination.
Renal and urinary disorders RENAL CALCULI	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Reproductive system and breast disorders REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER, SPECIFY	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Cardiac disorders SINUS BRADYCARDIA	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	0.00% 0/5 • Duration of participation in study, until study termination.	18.2% 2/11 • Number of events 4 • Duration of participation in study, until study termination.
Respiratory, thoracic and mediastinal disorders SLEEP APNEA	0.00% 0/5 • Duration of participation in study, until study termination.	18.2% 2/11 • Number of events 2 • Duration of participation in study, until study termination.
Infections and infestations TOOTH INFECTION	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Renal and urinary disorders URINARY FREQUENCY	0.00% 0/5 • Duration of participation in study, until study termination.	45.5% 5/11 • Number of events 5 • Duration of participation in study, until study termination.
Investigations WEIGHT GAIN	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.
Investigations WHITE BLOOD CELL DECREASED	0.00% 0/5 • Duration of participation in study, until study termination.	9.1% 1/11 • Number of events 1 • Duration of participation in study, until study termination.

Additional Information

Clinicaltrials.gov Results Coordinator

Hoosier Cancer Research Network

Phone: 317.921.2050

Email: jsmith@hoosiercancer.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place