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

NCT04887506 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: TAVT45C022020-005611-46
• Study Type: interventional
• Target: 107
• Locations: 8 countries
• Sites: 42

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.

Conditions

Metastatic Castration-resistant Prostate Cancer; Metastatic Castration-sensitive Prostate Cancer; Metastatic Prostate Cancer

Keywords

Prostate; Metastatic; Cancer

Outcome Measures

Primary Outcomes (1)

• Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), CR-ITT

  The primary endpoint was the between group comparison of serum testosterone levels for the average of levels on Days 9 and 10 (rounded-up) for mCRPC patients.

  Average over Day 9 and Day 10

Secondary Outcomes (3)

• Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), CS-ITT

  Average over Day 9 and Day 10

• Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), mITT

  Average over Day 9 and Day 10

• Percent of Subjects With PSA-50 Response, mITT

  Response at any time over the 84-day post-treatment period.

Study Arms (2)

TAVT-45

EXPERIMENTAL

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; Drug: Prednisone

Reference abiraterone acetate (Zytiga®) - R-AA

ACTIVE COMPARATOR

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; Drug: Prednisone

Interventions

TAVT-45 DRUG

250 mg abiraterone acetate granules for oral suspension in a sachet, reconstituted in water or specified fruit juice (orange juice), administered twice daily.

TAVT-45

Zytiga DRUG

500 mg tablet, two tablets administered once daily

Also known as: Abiraterone Acetate

Reference abiraterone acetate (Zytiga®) - R-AA

Prednisone DRUG

mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily.

Also known as: Encorton

Reference abiraterone acetate (Zytiga®) - R-AA; TAVT-45

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained prior to any study-related procedure being performed
• Male patients at least 18 years of age or older at time of consent
• Pathologically confirmed adenocarcinoma of the prostate
• 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
• Have either metastatic CSPC or metastatic CRPC (per protocol definitions).
• The following prior treatments and/or surgery for prostate cancer are allowed:
• 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
• CRPC:
• Previous chemotherapy with docetaxel for metastatic disease with treatment completed at least 1 year prior to screening
• 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
• Discontinuation of strong cytochrome P450 3A4 (CYP3A4) inducers at least 4 weeks prior to start of study medication
• Discontinuation of radiotherapy prior to start of study medication

You may not qualify if:

• For mCRPC patients:
• Prior treatment with abiraterone or enzalutamide is prohibited
• 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.
• Therapy with estrogen within 4 weeks prior to the start of study drug
• 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
• 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)
• History of adrenal gland dysfunction defined as requiring treatment for adrenal insufficiency
• 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
• Major surgery within 4 weeks prior to the start of study drug
• 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
• 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)
• Poorly controlled diabetes, defined as hemoglobin A1c (HbA1c) \> 8% within the past 12 months
• Uncontrolled hypertension at screening
• History of New York Heart Association class III or IV heart failure
• Serious concurrent illness, including psychiatric illness, that could interfere with study participation

Sponsors & Collaborators

• Tavanta Therapeutics: lead

Study Sites (42)

Research Site

Homewood, Alabama, 35209, United States

Location

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Tucson, Arizona, 85715, United States

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Little Rock, Arkansas, 72211, United States

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Los Angeles, California, 90048, United States

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San Bernardino, California, 92404, United States

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Denver, Colorado, 80211, United States

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Bradenton, Florida, 34205, United States

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Meridian, Idaho, 83642, United States

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Jeffersonville, Indiana, 47130, United States

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Annapolis, Maryland, 21401, United States

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Troy, Michigan, 48084, United States

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New York, New York, 10016, United States

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Virginia Beach, Virginia, 23462, United States

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Suresnes, Hauts-de-Seine, 92151, France

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Brest, 29200, France

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Budapest, 1062, Hungary

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Budapest, 1122, Hungary

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Debrecen, 4032, Hungary

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Warsaw, Masovia, 02-351, Poland

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Bydgoszcz, 85-048, Poland

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Lublin, 20-718, Poland

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Piaseczno, 05-500, Poland

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Warsaw, 02-119, Poland

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Ponce, 00731, Puerto Rico

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Madrid, Arturo Soria, 270, 28033, Spain

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Madrid, Av. Reyes Católicos 2, 28040, Spain

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Manresa, Barcelona, 08243, Spain

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Madrid, Calle de Oña 10, 28050, Spain

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Barcelona, Sabadell, 08208, Spain

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Barcelona, 08041, Spain

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Barcelona, 08907, Spain

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Lleida, 25198, Spain

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Madrid, 28041, Spain

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Seville, 41013, Spain

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Gothenburg, SE-413 45, Sweden

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Västerås, SE-721 89, Sweden

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Torquay, Devon, TQ2 7AA, United Kingdom

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Cheltenham, Gloucestershire, GL53 7AN, United Kingdom

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Hampstead, London, NW3 2QS, United Kingdom

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Glasgow, Scotland, G12 0YN, United Kingdom

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Guildford, Surrey, GU2 7XX, United Kingdom

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London, SW3 6JJ, United Kingdom

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Related Links

• Sponsors website

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

Abiraterone Acetate; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Results Point of Contact

• Title: Head, Clinical Development
• Organization: Tavanta Therapeutics

info@tavanta.com

+1 833776 8963

Study Officials

• Andreas Maetzel, MD, PhD

  Tavanta Therapeutics inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 14, 2021
• Study Start: May 5, 2021
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: January 16, 2024
• Results First Posted: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5); FR (2); ES (10); SE (2); PR (1); HU (3); US (13); GB (6)