Trial Outcomes & Findings for S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy (NCT NCT01309672)

NCT ID: NCT01309672

Last Updated: 2025-02-26

Results Overview

undetectable PSA defined as \<= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

12 months

Results posted on

2025-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Abiraterone Acetate + Prednisone Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Overall Study STARTED	41
Overall Study Received Protocol Treatment	40
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Abiraterone Acetate + Prednisone Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Overall Study Lack of Efficacy	20
Overall Study Other	9
Overall Study Adverse Event	5
Overall Study Withdrawal by Subject	3

Baseline Characteristics

S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abiraterone Acetate + Prednisone n=40 Participants Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Age, Continuous	66 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	40 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	10 Participants n=99 Participants
Race (NIH/OMB) White	27 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	4 Participants n=99 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic/unknown	36 Participants n=99 Participants
Testosterone	12.8 ng/dL n=99 Participants
PSA at entry	23.6 ng/mL n=99 Participants
Performance Status 0-1	39 Participants n=99 Participants
Performance Status 2	1 Participants n=99 Participants
Gleason Score 2-6	3 Participants n=99 Participants
Gleason Score 7	7 Participants n=99 Participants
Gleason Score 8-10	30 Participants n=99 Participants
Metastasis Bone	37 Participants n=99 Participants
Metastasis Lymph node	8 Participants n=99 Participants
Metastasis Visceral	6 Participants n=99 Participants
Prostate RT Yes	5 Participants n=99 Participants
Prostate RT No	35 Participants n=99 Participants
Prostatectomy Yes	5 Participants n=99 Participants
Prostatectomy No	35 Participants n=99 Participants
Antiandrogen use Yes	35 Participants n=99 Participants
Antiandrogen use No	5 Participants n=99 Participants
PSA status at registration Rising level	34 Participants n=99 Participants
PSA status at registration Stable/falling level	6 Participants n=99 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All patients who received at least 1 dose of protocol treatment

undetectable PSA defined as \<= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate + Prednisone n=40 Participants Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Number of Patients With Undetectable PSA	5 Participants

SECONDARY outcome

Timeframe: 12 months

PSA reduction to \< 4 ng/ml, but \>0.2 ng/ml

Outcome measures

Outcome measures
Measure	Abiraterone Acetate + Prednisone n=40 Participants Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Number of Patients With PSA Partial Response	13 Participants

SECONDARY outcome

Timeframe: 3 years

Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate + Prednisone n=40 Participants Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Objective Progression-free Survival	17.5 months Interval 8.6 to 25.0

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Abiraterone Acetate + Prednisone n=40 Participants Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Overall Survival	25.8 months Interval 15.7 to 25.8

SECONDARY outcome

Timeframe: Up to 3 years

Population: All participants receiving at least some protocol treatment

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Outcome measures
Measure	Abiraterone Acetate + Prednisone n=40 Participants Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Number of Patients With Toxicity of Abiraterone Acetate Aspartate aminotransferase increased	2 Participants
Number of Patients With Toxicity of Abiraterone Acetate Hyperglycemia	2 Participants
Number of Patients With Toxicity of Abiraterone Acetate Hypertension	2 Participants
Number of Patients With Toxicity of Abiraterone Acetate Alanine aminotransferase increased	2 Participants
Number of Patients With Toxicity of Abiraterone Acetate Anorexia	1 Participants
Number of Patients With Toxicity of Abiraterone Acetate Hypokalemia	2 Participants
Number of Patients With Toxicity of Abiraterone Acetate INR increased	1 Participants
Number of Patients With Toxicity of Abiraterone Acetate Leukocytosis	1 Participants
Number of Patients With Toxicity of Abiraterone Acetate Lung infection	1 Participants
Number of Patients With Toxicity of Abiraterone Acetate Nausea	2 Participants
Number of Patients With Toxicity of Abiraterone Acetate Rectal hemorrhage	1 Participants
Number of Patients With Toxicity of Abiraterone Acetate Thromboembolic event	1 Participants
Number of Patients With Toxicity of Abiraterone Acetate Vomiting	2 Participants
Number of Patients With Toxicity of Abiraterone Acetate Weight gain	1 Participants

Adverse Events

Abiraterone Acetate + Prednisone

Serious events: 16 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Abiraterone Acetate + Prednisone n=40 participants at risk Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Blood and lymphatic system disorders Anemia	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Blood and lymphatic system disorders Leukocytosis	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Cardiac disorders Aortic valve disease	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Cardiac disorders Atrial flutter	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Eye disorders Retinal detachment	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Abdominal pain	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Constipation	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Nausea	7.5% 3/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Rectal hemorrhage	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Small intestinal obstruction	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Vomiting	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
General disorders Death NOS	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
General disorders Fatigue	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
General disorders Fever	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Hepatobiliary disorders Cholecystitis	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Infections and infestations Lung infection	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Infections and infestations Urinary tract infection	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Injury, poisoning and procedural complications Hip fracture	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Injury, poisoning and procedural complications Injury, poison and procedural complications - Other	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Injury, poisoning and procedural complications Postoperative hemorrhage	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Investigations Alanine aminotransferase increased	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Investigations Aspartate aminotransferase increased	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Investigations Blood bilirubin increased	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Anorexia	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hyperglycemia	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hyperkalemia	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hypokalemia	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Back pain	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tiss disorder - Other	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Nervous system disorders Paresthesia	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Vascular disorders Hypertension	2.5% 1/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Vascular disorders Thromboembolic event	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.

Other adverse events

Other adverse events
Measure	Abiraterone Acetate + Prednisone n=40 participants at risk Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
Blood and lymphatic system disorders Anemia	30.0% 12/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	7.5% 3/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Ear and labyrinth disorders Ear and labyrinth disorders-Other	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Abdominal pain	10.0% 4/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Constipation	22.5% 9/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Diarrhea	7.5% 3/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Gastroesophageal reflux disease	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Gastrointestinal disorders-Other	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Nausea	17.5% 7/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Gastrointestinal disorders Vomiting	17.5% 7/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
General disorders Chills	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
General disorders Edema limbs	20.0% 8/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
General disorders Fatigue	37.5% 15/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
General disorders Pain	15.0% 6/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Infections and infestations Bronchial infection	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Infections and infestations Infections and infestations-Other	7.5% 3/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Infections and infestations Upper respiratory infection	10.0% 4/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Injury, poisoning and procedural complications Bruising	10.0% 4/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Injury, poisoning and procedural complications Fracture	7.5% 3/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Investigations Alanine aminotransferase increased	17.5% 7/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Investigations Alkaline phosphatase increased	35.0% 14/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Investigations Aspartate aminotransferase increased	25.0% 10/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Investigations Blood bilirubin increased	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Investigations Creatinine increased	12.5% 5/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Investigations Lymphocyte count decreased	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Investigations Platelet count decreased	10.0% 4/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Investigations Weight gain	12.5% 5/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Anorexia	7.5% 3/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Dehydration	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hypercalcemia	7.5% 3/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hyperglycemia	35.0% 14/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hyperkalemia	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hypernatremia	12.5% 5/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hypoalbuminemia	12.5% 5/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hypocalcemia	12.5% 5/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hypoglycemia	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hypokalemia	17.5% 7/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Metabolism and nutrition disorders Hyponatremia	12.5% 5/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 4/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Back pain	25.0% 10/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Bone pain	17.5% 7/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Chest wall pain	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Flank pain	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.5% 3/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tiss disorder - Other	10.0% 4/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 4/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Musculoskeletal and connective tissue disorders Pain in extremity	15.0% 6/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Nervous system disorders Dizziness	12.5% 5/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Nervous system disorders Headache	10.0% 4/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Nervous system disorders Nervous system disorders-Other	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Psychiatric disorders Insomnia	15.0% 6/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Renal and urinary disorders Urinary frequency	7.5% 3/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Reproductive system and breast disorders Pelvic pain	10.0% 4/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Respiratory, thoracic and mediastinal disorders Cough	15.0% 6/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 4/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Respiratory, thoracic and mediastinal disorders Resp, thoracic and mediastinal disorders - Other	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Skin and subcutaneous tissue disorders Rash acneiform	7.5% 3/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	7.5% 3/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Surgical and medical procedures Surgical and medical procedures-Other	5.0% 2/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Vascular disorders Hot flashes	27.5% 11/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
Vascular disorders Hypertension	37.5% 15/40 • Up to 3 years Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.

Additional Information

Dr. Thomas W. Flaig, MD

University of Colorado, School of Medicine

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place