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TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04887506
Recruitment Status : Recruiting
First Posted : May 14, 2021
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Tavanta Therapeutics

Brief Summary:
The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Metastatic Castration-sensitive Prostate Cancer Metastatic Prostate Cancer Drug: TAVT-45 Drug: Zytiga Drug: Prednisone Phase 3

Detailed Description:

This is a Phase 3 randomized, open-label study to evaluate the pharmacodynamic effect and safety profile of TAVT-45 compared to Zytiga (reference abiraterone acetate formulation, hereafter referred to as R-AA) in patients with mCSPC and mCRPC. Randomization will be stratified by prostate cancer population (CSPC vs CRPC) and baseline testosterone (<10 vs ≥ 10 ng/dL). Patients will be treated for 84 days and randomized into one of two groups in a 1:1 ratio:

  • TAVT-45: Administered twice daily as 1 x sachet containing TAVT-45 (250 mg abiraterone acetate) + Prednisone (5 mg once or twice daily, depending on prostate cancer population)
  • R-AA: Administered once daily as (2 x 500 mg Zytiga tablets) + Prednisone (5 mg once or twice daily, depending on prostate cancer population)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study Investigating the Efficacy and Safety of TAVT-45 (Abiraterone Acetate) Granules for Oral Suspension (Novel Abiraterone Acetate Formulation) Relative to a Reference Abiraterone Acetate Formulation in Patients With mCSPC & mCRPC
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAVT-45
TAVT-45 administered twice daily as a 1 x sachet containing TAVT-45 (250 mg abiraterone acetate) + Prednisone (5mg once or twice daily, depending on prostate cancer population). TAVT-45 administered approximately every 12 hours without respect to food. Patients treated for 84 days.
Drug: TAVT-45
250 mg abiraterone acetate granules for oral suspension in a sachet, administered twice daily.

Drug: Prednisone
mCSPC patients will receive 5 mg orally once daily. mCRPC patients will receive 5 mg orally twice daily.
Other Name: Encorton

Active Comparator: Reference abiraterone acetate (Zytiga®) - R-AA
Zytiga (reference abiraterone acetate formulation, hereafter referred to as R-AA) administered once daily as (2 x 500mg Zytiga tablets) + Prednisone (5mg once or twice daily, depending on prostate cancer population). R-AA administered once daily either ≥ 1 hour before or ≥ 2 hours after a meal. Patients treated for 84 days.
Drug: Zytiga
500 mg tablet, administered twice daily.
Other Name: Abiraterone Acetate

Drug: Prednisone
mCSPC patients will receive 5 mg orally once daily. mCRPC patients will receive 5 mg orally twice daily.
Other Name: Encorton




Primary Outcome Measures :
  1. Testosterone Levels [ Time Frame: Average over Day 9 and Day 10 ]
    Blood samples collected to measure serum testosterone in order to demonstrate equivalent pharmacodynamic effect between TAVT-45 and reference abiraterone acetate (R-AA)


Secondary Outcome Measures :
  1. Percent of Subjects With PSA-50 Response [ Time Frame: Over 84 days ]
    Blood samples collected to measure prostate-specific antigen (PSA). The PSA-50 response is defined as a decrease of ≥ 50% in PSA levels from baseline

  2. Testosterone Levels [ Time Frame: Days 28, 56 and 84 ]
    Blood samples collected to measure serum testosterone levels

  3. Percent of Subjects With PSA-50 Response [ Time Frame: Days 28, 56, and 84 ]
    Blood samples collected to measure PSA in order to determine PSA-50

  4. PSA Levels [ Time Frame: Days 28, 56, and 84 ]
    Blood samples collected to measure PSA

  5. Trough concentrations of abiraterone [ Time Frame: Days 9, 28, 56, and 84 ]
    Blood samples collected to measure plasma concentrations of abiraterone (trough sample to be collected before next dose)

  6. Pharmacokinetic analysis of AUC [ Time Frame: Days 1 and 9 ]
    Blood samples collected to measure plasma concentrations of abiraterone in a cohort of up to 8 patients randomized to TAVT-45 and participating in the serial PK sampling

  7. Pharmacokinetic analysis of Cmax [ Time Frame: Days 1 and 9 ]
    Blood samples collected to measure plasma concentrations of abiraterone in a cohort of up to 8 patients randomized to TAVT-45 and participating in the serial PK sampling

  8. Pharmacokinetic analysis of Cmin [ Time Frame: Days 1 and 9 ]
    Blood samples collected to measure plasma concentrations of abiraterone in a cohort of up to 8 patients randomized to TAVT-45 and participating in the serial PK sampling

  9. Pharmacokinetic analysis of Tmax [ Time Frame: Days 1 and 9 ]
    Blood samples collected to measure plasma concentrations of abiraterone in a cohort of up to 8 patients randomized to TAVT-45 and participating in the serial PK sampling

  10. Pharmacokinetic analysis of Rac [ Time Frame: Days 1 and 9 ]
    Blood samples collected to measure plasma concentrations of abiraterone in a cohort of up to 8 patients randomized to TAVT-45 and participating in the serial PK sampling

  11. Pharmacokinetic analysis of t1/2 [ Time Frame: Days 1 and 9 ]
    Blood samples collected to measure plasma concentrations of abiraterone in a cohort of up to 8 patients randomized to TAVT-45 and participating in the serial PK sampling



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent obtained prior to any study-related procedure being performed
  2. Male patients at least 18 years of age or older at time of consent
  3. Pathologically confirmed adenocarcinoma of the prostate
  4. Ongoing therapy with a gonadotropin releasing hormone (GnRH) agonist or antagonist (unless patient has already had a bilateral orchiectomy) AND serum testosterone level <50 ng/dL at screening
  5. Have either metastatic CSPC or metastatic CRPC (per protocol definitions).
  6. The following prior treatments and/or surgery for prostate cancer are allowed:

    1. CSPC:

      • Up to 90 days of androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists/antagonists or orchiectomy with or without concurrent anti-androgens prior to patients' randomization is permitted
      • Patients may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease (e.g., impending cord compression or obstructive symptoms) if administered prior to randomization
      • Radiation or surgical therapy that was not initiated 4 weeks after the start of ADT or orchiectomy
    2. CRPC:

      • Previous chemotherapy with docetaxel for metastatic disease with treatment completed at least 1 year prior to enrolment
  7. Discontinuation of flutamide or nilutamide, and other anti-androgens prior to the start of study medication; discontinuation of bicalutamide prior to start of study medication
  8. Discontinuation of strong CYP3A4 inducers at prior to start of study medication
  9. Discontinuation of radiotherapy prior to start of study medication
  10. Discontinuation of herbal supplements at least 4 weeks prior to the first dose of study medication and for the duration of the trial.
  11. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening
  12. Normal organ function with acceptable initial laboratory values within the screening period:

    • ANC: ≥ 1,500/μl
    • Albumin: ≥ 3.0g/dL
    • Hemoglobin: ≥ 9g/dL
    • Platelet count: ≥ 100,000/μl
    • Serum Creatinine: ≤ 3.0 x the institutional upper limit of normal (ULN)
    • Potassium: ≥ 3.5 mmol/L (within institutional normal range)
    • Bilirubin: ≤ 1.5 ULN (unless documented Gilbert's disease)
    • SGOT (AST): ≤ 2.5 x ULN
    • SGPT (ALT): ≤ 2.5 x ULN
  13. Life expectancy of at least 6 months at screening
  14. Patients engaged in sex with women of child-bearing potential agree to use a condom plus another effective contraception method. Patients agree to use a condom when engaged in any sexual activity, including sex with a pregnant woman. These restrictions will apply from the time informed consent is provided until 3 weeks after the last dose of study medication is taken.
  15. Patient is willing and able to comply with all protocol requirements

Exclusion Criteria:

  1. For mCSPC patients: any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer not specified as allowable treatment in Inclusion Criterion 6. For example, prior therapy with apalutamide or enzalutamide is prohibited as well as therapy with an investigational agent as described in Exclusion Criterion 16.
  2. For mCRPC patients:

    • Prior treatment with abiraterone or enzalutamide is prohibited
    • Previous chemotherapy is prohibited with exception of docetaxel treatment as specified in the inclusion criteria 6.
  3. Initiation of bisphosphonate or denosumab therapy within 4 weeks prior to the start of study drug/reference product. Patients who are on a stable dose of these medications for at least 4 weeks at the time of starting study drug/reference product will be eligible.
  4. Therapy with estrogen within 4 weeks prior to the start of study drug
  5. Use of systemic glucocorticoids equivalent to >10 mg prednisone daily. Patients who have discontinued or reduced dosing to the equivalent of ≤ 10 mg prednisone daily within 14 days prior to the start of study drug are eligible
  6. Known, symptomatic metastases to the brain or central nervous system involvement (patients with asymptomatic and neurologically stable disease for the past 4 weeks will be permitted)
  7. History of adrenal gland dysfunction defined as requiring treatment for adrenal insufficiency
  8. History of other malignancy within the previous 2 years (no longer being actively treated), with the exceptions of basal cell carcinoma, nonmuscle invasive bladder cancer that has been treated and is under surveillance, or other in-situ cancers with a low likelihood of recurrence
  9. Major surgery within 4 weeks prior to the start of study drug
  10. Known gastrointestinal disease or condition that could impair absorption inclusive of gastrocolic fistula, gastroenterostomy, biliary obstruction, cirrhosis, chronic pancreatitis or pancreatic cancer, cystic fibrosis, lactate deficiency, amyloidosis, celiac disease, Crohn's disease, radiation enteritis, intestinal resection, and history of bariatric surgery
  11. Known history of human immunodeficiency virus or seropositive test for hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg) (note: HCV patients with undetectable viral load will be eligible)
  12. Poorly controlled diabetes, defined as HbA1c > 8% within the past 12 months
  13. Uncontrolled hypertension at screening
  14. History of New York Heart Association class III or IV heart failure
  15. Serious concurrent illness, including psychiatric illness, that could interfere with study participation
  16. Receipt of another investigational agent within 4 weeks or 5 x the treatment half-life, whichever is longer, of treatment start.
  17. Known hypersensitivity or allergy to abiraterone acetate, prednisone or any excipients in the study drugs
  18. In the opinion of the investigator, participation in the trial would prevent the patient from receiving local standard-of-care treatment for metastatic prostate cancer, if clinically indicated, after completion of the trial
  19. Other condition which, in the opinion of the Investigator, would preclude participation in this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887506


Contacts
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Contact: Dominic Capone +16093100378 dominic.capone@tavanta.com

Locations
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United States, Arkansas
Arkansas Urology Research Center Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Jeffrey Marotte, MD    501-219-8900 ext 2002    JMarotte@arkansasurology.com   
United States, Colorado
The Urology Centre of Colorado, 2777 Mile High Stadium Circle, Recruiting
Denver, Colorado, United States, 80211
Contact: Lawrence Karsh, M.D    303-421-5783    lkarsh@tucc.com   
United States, Indiana
First Urology Recruiting
Jeffersonville, Indiana, United States, 47130
Contact: James Bailen, MD    812-206-8161    jbailen@1sturology.com   
Principal Investigator: James Bailen, MD         
United States, Maryland
Chesapeake Urology Research Associates Recruiting
Annapolis, Maryland, United States, 21401
Contact: Richard Levin, MD    443-471-3309    rlevin@chesuro.com   
United States, Michigan
Michigan Institute of Urology Recruiting
Troy, Michigan, United States, 48084
Contact: Kenneth M Kernen, MD    248-740-0670    kernenk@michiganurology.com   
United States, New York
Manhattan Medical Research Practice, PLLC Recruiting
New York, New York, United States, 10016
Contact: Jed Kaminetsky, MD    212-480-3333    jckaminetsky@manhattanmedicalresearch.com   
United States, Virginia
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Robert Given       rgiven@urologyfva.net   
Principal Investigator: Robert Given, MD         
Sponsors and Collaborators
Tavanta Therapeutics
Investigators
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Study Director: Kim Prescott, MBChB, MFPM TMC Pharma Services Ltd
Additional Information:
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Responsible Party: Tavanta Therapeutics
ClinicalTrials.gov Identifier: NCT04887506    
Other Study ID Numbers: TAVT45C02
2020-005611-46 ( EudraCT Number )
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

According to the Informed Consent Form:

  1. The health information that may be used and disclosed includes:

    • All information collected during the research described in the Informed Consent Form for the study; and
    • Health information in my medical records that is relevant to the study.
  2. The Providers may disclose health information in my medical records to:

    • Researchers;
    • The Sponsor of the study and its agents and contractors; and
    • Representatives of government agencies, Advarra IRB, and other persons who watch over the safety, effectiveness, and conduct of research.
  3. The Researchers may:

    • Use and share patient health information among themselves, with the Sponsor, and with other participating researchers and laboratories to conduct the study; and
    • Disclose health information to representatives of government agencies, review boards
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: The sponsor will store the data for at least 30 years after completion; or discontinuation of the study; or for at least 30 years after the granting of the last marketing authorization until there are no more pending; or contemplated marketing applications; or for at least 30 years after formal discontinuation of the clinical development of the study drug, or are scheduled for submission
Access Criteria: The Sponsor will ensure that its affiliated companies or its third-party data processors that analyze data on behalf of the Sponsor treat all patient data in a confidential manner and in accordance with 'The Health Insurance Portability and Accountability Act of 1996' (HIPAA).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tavanta Therapeutics:
Prostate
Metastatic
Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Prednisone
Abiraterone Acetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors