Trial Outcomes & Findings for Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer (NCT NCT01866423)
NCT ID: NCT01866423
Last Updated: 2017-08-31
Results Overview
The two-sample t-test will be used. Once association between AR protein expression levels and response is established, graphical methods such as receiver-operator curves (ROC) or more quantitative methods such as the maximal chi-square method to determine whether there might be a cut-point with either great sensitivity or great specificity (or both) for identifying a cohort with either a high or low likelihood of prostate-specific antigen (PSA) response.
TERMINATED
PHASE2
4 participants
Up to 4 weeks
2017-08-31
Participant Flow
Participants were recruited at the University of Southern California (USC) medical clinics from December 2013 to February 2014. Due to results of two phase III clinical trials in metastatic, castration resistant prostate cancer (mCRPC), the sponsor determined that the drug has not demonstrated a clinical profile sufficient to move forward in mCRPC.
The trial had no pre-assignment criteria. All subjects were given the same treatment.
Participant milestones
| Measure |
Treatment (Orteronel)
Patients receive orteronel 300 mg PO BID (twice a day) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Orteronel)
Patients receive orteronel 300 mg PO BID (twice a day) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Sponsor Decision
|
1
|
Baseline Characteristics
Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Orteronel)
n=4 Participants
Patients receive orteronel 300 mg PO twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Only 4 patients were accrued to this trial. No data analysis was performed.
The two-sample t-test will be used. Once association between AR protein expression levels and response is established, graphical methods such as receiver-operator curves (ROC) or more quantitative methods such as the maximal chi-square method to determine whether there might be a cut-point with either great sensitivity or great specificity (or both) for identifying a cohort with either a high or low likelihood of prostate-specific antigen (PSA) response.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At 12 weeksPopulation: Only 4 patients were accrued to this trial. No data analysis was performed.
Standard descriptive methods will be used to summarize PSA. Values will be tabulated as outlined in the Prostate Cancer Working Group 2 (PCWG2) criteria and presented as Kaplan-Meier survival curves, as appropriate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Only 4 patients was accrued to this trial. No data analysis was performed.
Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: Only 4 patients was accrued to this trial. No data analysis was performed.
Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Only 4 patients was accrued to this trial. No data analysis was performed.
Response will be tabulated descriptively with 95% confidence intervals (CIs) and Kaplan-Meier survival curves, as appropriate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Only 4 patients was accrued to this trial. No data analysis was performed.
Response will be tabulated descriptively with 95% CIs and Kaplan-Meier survival curves, as appropriate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: Tracked during treatment period until 30 days after last dose of study drug.
Summary of grade 3 (per Common Terminology Criteria for Adverse Events (CTCAE v4.0) or higher toxicities which generally is described as a severe reaction or symptom.
Outcome measures
| Measure |
Treatment (Orteronel)
n=4 Participants
Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Participants With Grade 3 or Higher Toxicity
|
1 Participants
|
Adverse Events
Treatment (Orteronel)
Serious adverse events
| Measure |
Treatment (Orteronel)
n=4 participants at risk
Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
Other adverse events
| Measure |
Treatment (Orteronel)
n=4 participants at risk
Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
orteronel: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abodminal Pain
|
50.0%
2/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Metabolism and nutrition disorders
Anorexia
|
75.0%
3/4 • Number of events 3 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Endocrine disorders
Adrenal insufficiency
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Investigations
Aspartate Aminotransferase increased
|
50.0%
2/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
2/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
1/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Injury, poisoning and procedural complications
Bruising
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Cardiac disorders
Chest pain - cardiac
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 4 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
3/4 • Number of events 4 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Investigations
Creatinine increased
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 4 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
General disorders
Fever
|
50.0%
2/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Renal and urinary disorders
Hematuria
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
2/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Psychiatric disorders
Libido decreased
|
50.0%
2/4 • Number of events 3 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Gastrointestinal disorders
Stomach pain
|
50.0%
2/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Infections and infestations
Tooth infection
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Gastrointestinal disorders
Toothache
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Renal and urinary disorders
Urinary frequency
|
25.0%
1/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
|
Investigations
White blood cell decreased
|
25.0%
1/4 • Number of events 1 • Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).
|
Additional Information
Victoria Soto, Project Specialist
USC Norris Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place