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
Overview
- Phase
- Phase 3
- Intervention
- TAVT-45
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Sponsor
- Tavanta Therapeutics
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), CR-ITT
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
- •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
- •Previous chemotherapy with docetaxel for metastatic disease with treatment completed at least 1 year prior to screening
Exclusion Criteria
- •For mCSPC patients: any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer not specified as allowable treatment in Inclusion Criterion
- •For example, prior therapy with apalutamide or enzalutamide is prohibited as well as therapy with an investigational agent as described in Exclusion Criterion
- •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
- •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
Arms & Interventions
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.
Intervention: TAVT-45
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.
Intervention: Prednisone
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.
Intervention: Zytiga
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.
Intervention: Prednisone
Outcomes
Primary Outcomes
Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), CR-ITT
Time Frame: Average over Day 9 and Day 10
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.
Secondary Outcomes
- 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.)
- Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), CS-ITT(Average over Day 9 and Day 10)