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STAAR: A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer

Sponsor
Sun Pharmaceutical Industries Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT02737332
Collaborator
(none)
53
Enrollment
17
Locations
2
Arms
11.3
Actual Duration (Months)
3.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the serum testosterone levels in patients with Metastatic Castration-Resistant Prostate Cancer on SoluMatrix™ Abiraterone Acetate as Compared to Abiraterone Acetate

Condition or Disease Intervention/Treatment Phase
  • Drug: Zytiga® (Abiraterone Acetate)
  • Drug: SoluMatrix™ (Abiraterone Acetate)
 Phase 2

Detailed Description

This was a 12-week, open-label study of abiraterone acetate in at least 50 patients with metastatic castration-resistant prostate cancer.

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer: The STAAR STUDY
Actual Study Start Date :
Mar 21, 2016
Actual Primary Completion Date :
Feb 27, 2017
Actual Study Completion Date :
Feb 27, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Zytiga® (Abiraterone Acetate)

1,000 MG (4 x 250 mg qd)

Drug: Zytiga® (Abiraterone Acetate)
Zytiga® 1,000 mg (4 x 250 mg qd) tablets plus one 5 mg prednisone tablet to be taken bid, spaced approximately 12 hours apart
Other Names:
  • Zytiga®

    		•
    Experimental: SoluMatrix™ (Abiraterone Acetate)

    500 mg (4 x 125 mg qd)

    Drug: SoluMatrix™ (Abiraterone Acetate)
    SoluMatrix™ 500 mg (4 x 125 mg qd) tablets plus one 4 mg methylprednisolone tablet bid, spaced approximately 12 hours apart
    Other Names:
  • SoluMatrix™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Testosterone Levels [Average of Day 9 and 10]

      Blood Sample tested for Serum Testosterone Levels

    Secondary Outcome Measures

    1. PSA Levels [Day 28, Day 56, and Day 84]

      All patients randomized to one of the two treatment groups, round about level of PSA. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint

    2. Percent of Subjects With PSA-50 Response [Day 28, Day 56, and Day 84]

      Proportion of patients with complete suppression of PSA-50 were reported by treatment and compared for between-group differences. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

    3. Serum Testosterone Levels [Day 28, Day 56, and Day 84]

      These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

    4. Steady State Trough Concentration of Arbiraterone [Day 09, Day 28, Day 56, and Day 84]

      These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

    5. AUC (0-inf) [60 to 30 minutes prior to dosing and over 24 Hours post-dose]

      Steady state systemic exposure parameters

    6. AUC (0-24 hr) [60 to 30 minutes prior to dosing and over 24 Hours post-dose]

      Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

    7. AUC (0-t) [60 to 30 minutes prior to dosing and over 24 Hours post-dose]

      Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

    8. Cmax [60 to 30 minutes prior to dosing and over 24 Hours post-dose]

      Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Written informed consent obtained prior to any study-related procedure being performed

    2. Male subjects at least 18 years of age or older at time of consent

    3. Pathologically confirmed adenocarcinoma of the prostate

    4. Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level <50 ng/dL at screening

    5. Metastatic disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI) or bone scan. Imaging obtained within 42 days prior to the start of study medication will be accepted.

    6. Meeting disease progression according to the recommendations of the prostate cancer working group 2 by one of the following criteria:

    • Two rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 2 ng/mL,

    • Imaging progression (CT/MRI) by RECIST criteria

    • Nuclear scan progression by new lesion.

    1. Discontinuation of flutamide or nilutamide, and other anti-androgens at least 4 weeks prior to the start of study medication; discontinuation of bicalutamide at least 6 weeks prior to start of study medication.

    2. Discontinuation of Radiotherapy > 4 weeks prior to start of study medication.

    3. ECOG performance status of 0-1 at screening

    4. Screening blood counts of the following:

    • Absolute neutrophil count > 1500/µL

    • Platelets > 100,000/µL

    • Hemoglobin > 9 g/dL

    1. Screening chemistry values of the following:

    • ALT and AST < 2.5 x ULN

    • Total bilirubin < 1.5 x ULN

    • Creatinine< 1.5 x ULN

    • Albumin > 3.0 g/dL

    1. Potassium > 3.5 mmol/L

    2. Life expectancy of at least 6 months at screening

    3. Subject is willing and able to comply with all protocol requirements assessments

    4. Agrees to protocol-defined use of effective contraception.

    Exclusion Criteria:

    1. History of impaired pituitary or adrenal gland function

    2. Prior therapy with abiraterone acetate, orteronel, ketoconazole or any other CYP17 inhibitor

    3. Prior therapy with enzalutamide

    4. Prior use of experimental androgen receptor antagonist

    5. Previous exposure to Ra-223:Xofigo

    6. Previous chemotherapy

    7. Initiation of bisphosphonate or denosumab therapy within 30 days prior to the start of study medication. Patients who are on a stable dose of these medications for at least 30 days at the time of starting study drug are eligible.

    8. Therapy with estrogen within 30 days prior to the start of study medication

    9. Use of systemic glucocorticoids equivalent to > 10 mg of prednisone daily; patients who have discontinued or have reduced dose to < 10 mg prednisone within 14 days prior to the start of study medication will be eligible

    10. Prior use of any herbal products that may decrease PSA levels (eg., saw palmetto) within 30 days of start of study medication

    11. Known metastases to the brain or CNS involvement

    12. History of other malignancy within the previous 2 years

    13. Major surgery within 30 days prior to the start of study medication

    14. Blood transfusion within 30 days of screening

    15. Serious, persistent infection within 14 days of the start of study medication

    16. Persistent pain that requires the use of a narcotic analgesic

    17. Known gastrointestinal disease or condition that may impair absorption

    18. Treatment with any investigational drug within 4 weeks prior to Day -1 of the study.

    19. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus

    20. Have poorly controlled diabetes.

    21. Uncontrolled hypertension

    22. History of New York Heart Association (NYHA) class III or IV heart failure

    23. Serious concurrent illness, including psychiatric illness, that would interfere with study participation

    24. Inability to swallow tablets whole

    25. Known hypersensitivity to any excipients in study medications

    26. Moderate to severe hepatic impairment (Child-Pugh Classes B and C)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alliance Research Laguna Hills California United States 92653
    2 Tower Urology Los Angeles California United States 90048
    3 San Bernardino Urological San Bernardino California United States 92404
    4 Skyline Urology Torrance California United States 90505
    5 Innovative Clinical Research Institute Whittier California United States 90603
    6 Urology Associates, P.C. Englewood Colorado United States 80113
    7 Manatee Medical Research Bradenton Florida United States 34205
    8 North Idaho Urology Coeur d'Alene Idaho United States 83814
    9 The Iowa Clinic West Des Moines Iowa United States 50266
    10 Wichita Urology Group Wichita Kansas United States 67226
    11 Chesapeake Urology Research Associates Towson Maryland United States 21204
    12 Lincoln Urology, PC Lincoln Nebraska United States 68516
    13 Urology Cancer Center Omaha Nebraska United States 68130
    14 Brooklyn Urology Research Group Brooklyn New York United States 11215
    15 Associated Urologist of North Carolina Raleigh North Carolina United States 27612
    16 Urology Clinics of North Texas Dallas Texas United States 75231
    17 Urology of Virginia Virginia Beach Virginia United States 23462

    Sponsors and Collaborators

    • Sun Pharmaceutical Industries Limited

    Investigators

    • Study Director: Paul Nemeth, PhD,

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sun Pharmaceutical Industries Limited
    ClinicalTrials.gov Identifier:
    NCT02737332
    Other Study ID Numbers:
    • CHL-AA-201
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Abiraterone Acetate

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Arm/Group Description Zytiga® 1,000 mg (4 x 250 mg qd) tablets SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
    Period Title: Overall Study
    STARTED 29 24
    COMPLETED 28 23
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate) Total
    Arm/Group Description Zytiga® 1,000 mg (4 x 250 mg qd) tablets SoluMatrix™ 500 mg (4 x 125 mg qd) tablets Total of all reporting groups
    Overall Participants 29 24 53
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    73.5
    (9.4)
    77
    (8.9)
    75.1
    (9.3)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    29
    100%
    24
    100%
    53
    100%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    6.9%
    4
    16.7%
    6
    11.3%
    Not Hispanic or Latino
    27
    93.1%
    20
    83.3%
    47
    88.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    1
    4.2%
    1
    1.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    8
    27.6%
    3
    12.5%
    11
    20.8%
    White
    20
    69%
    20
    83.3%
    40
    75.5%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    3.4%
    0
    0%
    1
    1.9%
    Region of Enrollment (participants) [Number]
    United States
    29
    100%
    24
    100%
    53
    100%

    Outcome Measures

    1. Primary Outcome
    Title Testosterone Levels
    Description Blood Sample tested for Serum Testosterone Levels
    Time Frame Average of Day 9 and 10

    Outcome Measure Data

    Analysis Population Description
    Analysis of serum T levels in the ITT population
    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Arm/Group Description Zytiga® 1,000 mg (4 x 250 mg qd) tablets SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
    Measure Participants 29 24
    Mean (Standard Error) [ng/dL]
    1.02
    (0.03)
    1.05
    (0.04)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Equivalence
    Comments The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.
    Statistical Test of Hypothesis p-Value 0.4879
    Comments One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Geometric mean ratio of treatments
    Estimated Value 1.019
    Confidence Interval (2-Sided) 90%
    0.964 to 1.077
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
    2. Secondary Outcome
    Title PSA Levels
    Description All patients randomized to one of the two treatment groups, round about level of PSA. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint
    Time Frame Day 28, Day 56, and Day 84

    Outcome Measure Data

    Analysis Population Description
    ITT population:The intention-to-treat (ITT) population is defined as all subjects who are randomized to one of the two treatment groups. The ITT population is the primary population for PD evaluation. The ITT population will be identified and finalized before the database is locked.
    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Arm/Group Description Zytiga® 1,000 mg (4 x 250 mg qd) tablets SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
    Measure Participants 29 24
    Day 28
    37.5
    (11.33)
    22.37
    (12.02)
    Day 56
    40.84
    (12.58)
    25.29
    (13.68)
    Day 84
    33.88
    (13.43)
    26.46
    (15.41)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Other
    Comments The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.
    Statistical Test of Hypothesis p-Value 0.3642
    Comments One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.994
    Confidence Interval (2-Sided) 90%
    0.0451 to 2.192
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Equivalence
    Comments The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.
    Statistical Test of Hypothesis p-Value 0.4069
    Comments One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.810
    Confidence Interval (2-Sided) 90%
    0.338 to 1.939
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Equivalence
    Comments One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.
    Statistical Test of Hypothesis p-Value 0.7186
    Comments The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.039
    Confidence Interval (2-Sided) 90%
    0.412 to 2.617
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
    3. Secondary Outcome
    Title Percent of Subjects With PSA-50 Response
    Description Proportion of patients with complete suppression of PSA-50 were reported by treatment and compared for between-group differences. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.
    Time Frame Day 28, Day 56, and Day 84

    Outcome Measure Data

    Analysis Population Description
    ITT population:The intention-to-treat (ITT) population is defined as all subjects who are randomized to one of the two treatment groups. The ITT population is the primary population for PD evaluation. The ITT population will be identified and finalized before the database is locked.
    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Arm/Group Description Zytiga® 1,000 mg (4 x 250 mg qd) tablets SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
    Measure Participants 27 24
    Day 28
    70.4
    242.8%
    66.7
    277.9%
    Day 56
    65.4
    225.5%
    63.6
    265%
    Day 84
    72.0
    248.3%
    68.4
    285%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    4. Secondary Outcome
    Title Serum Testosterone Levels
    Description These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.
    Time Frame Day 28, Day 56, and Day 84

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Arm/Group Description Zytiga® 1,000 mg (4 x 250 mg qd) tablets SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
    Measure Participants 29 24
    Day 28
    1.01
    (0.01)
    1.01
    (0.01)
    Day 56
    1.01
    (1.03)
    2.56
    (1.07)
    Day 84
    1
    (0)
    1
    (0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Equivalence
    Comments The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.
    Statistical Test of Hypothesis p-Value 0.9211
    Comments One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 0.999
    Confidence Interval (2-Sided) 90%
    0.980 to 1.018
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
    Other Statistical Analysis ANOVA-model-based Least-Square Mean
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Equivalence
    Comments The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.
    Statistical Test of Hypothesis p-Value 0.3037
    Comments One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.168
    Confidence Interval (2-Sided) 90%
    0.900 to 1.515
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Equivalence
    Comments The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Geometric mean ratio
    Estimated Value 1.000
    Confidence Interval (2-Sided) 90%
    1.000 to 1.000
    Parameter Dispersion Type:
    Value:
    Estimation Comments Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.
    5. Secondary Outcome
    Title Steady State Trough Concentration of Arbiraterone
    Description These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.
    Time Frame Day 09, Day 28, Day 56, and Day 84

    Outcome Measure Data

    Analysis Population Description
    Safety Population
    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Arm/Group Description Zytiga® 1,000 mg (4 x 250 mg qd) tablets SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
    Measure Participants 28 23
    Day 09
    20.938
    (7.044)
    27.259
    (7.772)
    Day 28
    56.721
    (23.104)
    18.662
    (24.18)
    Day 56
    29.978
    (8.117)
    18.707
    (9.175)
    Day 84
    18.263
    (3.087)
    13.819
    (3.381)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5495
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2616
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3632
    Comments
    Method ANOVA
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3393
    Comments
    Method ANOVA
    Comments
    6. Secondary Outcome
    Title AUC (0-inf)
    Description Steady state systemic exposure parameters
    Time Frame 60 to 30 minutes prior to dosing and over 24 Hours post-dose

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Arm/Group Description Zytiga® 1,000 mg (4 x 250 mg qd) tablets SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
    Measure Participants 8 4
    Least Squares Mean (Standard Error) [ng*hr/mL]
    1020.218
    (154.549)
    326.458
    (218.565)
    7. Secondary Outcome
    Title AUC (0-24 hr)
    Description Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).
    Time Frame 60 to 30 minutes prior to dosing and over 24 Hours post-dose

    Outcome Measure Data

    Analysis Population Description
    Overall, 14 subjects were analyzed in the PK population, amongst which, 8 were in the Zytiga group and 5 were in the SoluMatrix group.
    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Arm/Group Description Zytiga® 1,000 mg (4 x 250 mg qd) tablets. SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
    Measure Participants 8 5
    Least Squares Mean (Standard Error) [ng*hr/mL]
    870.859
    (221.709)
    626.066
    (280.443)
    8. Secondary Outcome
    Title AUC (0-t)
    Description Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).
    Time Frame 60 to 30 minutes prior to dosing and over 24 Hours post-dose

    Outcome Measure Data

    Analysis Population Description
    Overall, 14 subjects were analyzed in the PK population, amongst which, 8 were in the Zytiga group and 5 were in the SoluMatrix group.
    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Arm/Group Description Zytiga® 1,000 mg (4 x 250 mg qd) tablets SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
    Measure Participants 8 5
    Least Squares Mean (Standard Error) [ng*hr/mL]
    870.859
    (221.709)
    626.066
    (280.443)
    9. Secondary Outcome
    Title Cmax
    Description Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).
    Time Frame 60 to 30 minutes prior to dosing and over 24 Hours post-dose

    Outcome Measure Data

    Analysis Population Description
    Overall, 14 subjects were analyzed in the PK population, amongst which, 8 were in the Zytiga group and 5 were in the SoluMatrix group.
    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Arm/Group Description Zytiga® 1,000 mg (4 x 250 mg qd) tablets 500 mg (4 x 125 mg qd) SoluMatrix™ (Abiraterone Acetate): SoluMatrix™ Abiraterone Acetate 500 mg Compared to Zytiga® 1,000 mg (4 x 250 mg qd)
    Measure Participants 8 5
    Least Squares Mean (Standard Error) [ng/mL]
    268.261
    (69.967)
    111.316
    (88.503)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Zytiga® (Abiraterone Acetate), SoluMatrix™ (Abiraterone Acetate)
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1917
    Comments
    Method ANOVA
    Comments

    Adverse Events

    Time Frame AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF.
    Adverse Event Reporting Description The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
    Arm/Group Title Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Arm/Group Description 1,000 MG (4 x 250 mg qd) Zytiga® (Abiraterone Acetate): Zytiga® 1,000 mg (4 x 250 mg qd) Compared to SoluMatrix™ Abiraterone Acetate 500 mg 500 mg (4 x 125 mg qd) SoluMatrix™ (Abiraterone Acetate): SoluMatrix™ Abiraterone Acetate 500 mg Compared to Zytiga® 1,000 mg (4 x 250 mg qd)
    All Cause Mortality
    Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/29 (6.9%) 0/24 (0%)
    Serious Adverse Events
    Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/29 (6.9%) 5/24 (20.8%)
    Cardiac disorders
    Corornary artery disease 0/29 (0%) 0 1/24 (4.2%) 1
    Myocardial infarction 1/29 (3.4%) 1 0/24 (0%) 0
    Infections and infestations
    Sepsis 0/29 (0%) 0 1/24 (4.2%) 1
    Pyelonephritis 0/29 (0%) 0 1/24 (4.2%) 1
    Vertigo 0/29 (0%) 0 1/24 (4.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Progression of prostate cancer 1/29 (3.4%) 1 0/24 (0%) 0
    Renal and urinary disorders
    Worsening of left hydroureteronephrosis 0/29 (0%) 0 1/24 (4.2%) 1
    Other (Not Including Serious) Adverse Events
    Zytiga® (Abiraterone Acetate) SoluMatrix™ (Abiraterone Acetate)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 22/29 (75.9%) 16/24 (66.7%)
    Gastrointestinal disorders
    Abdominal pain 0/29 (0%) 2/24 (8.3%)
    Nausea 3/29 (10.3%) 0/24 (0%)
    Vomiting 2/29 (6.9%) 0/24 (0%)
    Gastroesophgeal reflux disease 0/29 (0%) 1/24 (4.2%)
    General disorders
    Asthenia 2/29 (6.9%) 0/24 (0%)
    Oedema peripheral 0/29 (0%) 2/24 (8.3%)
    Thirst 0/29 (0%) 1/24 (4.2%)
    Infections and infestations
    Urinary tract infections 3/29 (10.3%) 4/24 (16.7%)
    Bacteriuria 0/29 (0%) 1/24 (4.2%)
    Cellulitis 0/29 (0%) 1/24 (4.2%)
    Investigations
    Blood creatiineincreased 2/29 (6.9%) 0/24 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 4/29 (13.8%) 1/24 (4.2%)
    Muscle spasms 4/29 (13.8%) 1/24 (4.2%)
    Muscular weakness 2/29 (6.9%) 0/24 (0%)
    Nervous system disorders
    Dizziness 4/29 (13.8%) 0/24 (0%)
    Skin and subcutaneous tissue disorders
    Night sweats 0/29 (0%) 1/24 (4.2%)
    Vascular disorders
    Hypertension 2/29 (6.9%) 1/24 (4.2%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Head, Clinical Development
    Organization SPARC
    Phone 912266455645
    Email clinical.trials@sparcmail.com
    Responsible Party:
    Sun Pharmaceutical Industries Limited
    ClinicalTrials.gov Identifier:
    NCT02737332
    Other Study ID Numbers:
    • CHL-AA-201
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021