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

NCT ID: NCT04887506

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2022-10-20

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.

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 high-risk metastatic castrate sensitive prostate cancer (mCSPC) and metastatic castrate resistant prostate cancer (mCRPC). Randomization was stratified by prostate cancer population (CSPC vs CRPC) and baseline testosterone (<10 vs ≥ 10 ng/dL). Patients were 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), reconstituted in water or specified fruit juice (orange juice), + 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)

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TAVT-45

Intervention Type: DRUG

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

Prednisone

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Zytiga

Intervention Type: DRUG

500 mg tablet, two tablets administered once daily

Prednisone

Intervention Type: DRUG

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

Interventions

TAVT-45

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

Intervention Type: DRUG

Zytiga

500 mg tablet, two tablets administered once daily

Intervention Type: DRUG

Prednisone

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

Intervention Type: DRUG

Other Intervention Names

Abiraterone Acetate; Encorton

Eligibility 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 screening

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 cytochrome P450 3A4 (CYP3A4) inducers at least 4 weeks 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:

• Absolute neutrophil count (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)
• Aspartate aminotransferase (AST): ≤ 2.5 x ULN
• Alanine aminotransferase (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

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 hemoglobin A1c (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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tavanta Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Maetzel, MD, PhD

Role: STUDY_CHAIR

Tavanta Therapeutics inc.

Locations

Research Site

Homewood, Alabama, United States

Research Site

Tucson, Arizona, United States

Research Site

Little Rock, Arkansas, United States

Research Site

Los Angeles, California, United States

Research Site

San Bernardino, California, United States

Research Site

Denver, Colorado, United States

Research Site

Bradenton, Florida, United States

Research Site

Meridian, Idaho, United States

Research Site

Jeffersonville, Indiana, United States

Research Site

Annapolis, Maryland, United States

Research Site

Troy, Michigan, United States

Research Site

New York, New York, United States

Research Site

Virginia Beach, Virginia, United States

Research Site

Suresnes, Hauts-de-Seine, France

Research Site

Brest, , France

Research Site

Budapest, , Hungary

Research Site

Budapest, , Hungary

Research Site

Debrecen, , Hungary

Research Site

Warsaw, Masovia, Poland

Research Site

Bydgoszcz, , Poland

Research Site

Lublin, , Poland

Research Site

Piaseczno, , Poland

Research Site

Warsaw, , Poland

Research Site

Ponce, , Puerto Rico

Research Site

Madrid, Arturo Soria, 270, Spain

Research Site

Madrid, Av. Reyes Católicos 2, Spain

Research Site

Manresa, Barcelona, Spain

Research Site

Madrid, Calle de Oña 10, Spain

Research Site

Barcelona, Sabadell, Spain

Research Site

Barcelona, , Spain

Research Site

Barcelona, , Spain

Research Site

Lleida, , Spain

Research Site

Madrid, , Spain

Research Site

Seville, , Spain

Research Site

Gothenburg, , Sweden

Research Site

Västerås, , Sweden

Research Site

Torquay, Devon, United Kingdom

Research Site

Cheltenham, Gloucestershire, United Kingdom

Research Site

Hampstead, London, United Kingdom

Research Site

Glasgow, Scotland, United Kingdom

Research Site

Guildford, Surrey, United Kingdom

Research Site

London, , United Kingdom

Countries

United States; France; Hungary; Poland; Puerto Rico; Spain; Sweden; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.tavanta.com/

Sponsors website

Other Identifiers

2020-005611-46

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TAVT45C02

Identifier Type: -

Identifier Source: org_study_id