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

  • STATUS
    Recruiting
  • End date
    Jun 18, 2022
  • participants needed
    108
  • sponsor
    Tavanta Therapeutics
Updated on 18 January 2022

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.

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)

Details
Condition Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer, Metastatic Prostate Cancer
Treatment prednisone, Zytiga, TAVT-45
Clinical Study IdentifierNCT04887506
SponsorTavanta Therapeutics
Last Modified on18 January 2022

Eligibility

Yes No Not Sure

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
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 enrolment
Discontinuation of flutamide or nilutamide, and other anti-androgens prior to the
start of study medication; discontinuation of bicalutamide prior to start of
Discontinuation of strong CYP3A4 inducers at prior to start of study medication
Discontinuation of radiotherapy prior to start of study medication
study medication
Discontinuation of herbal supplements at least 4 weeks prior to the first dose of study medication and for the duration of the trial
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening
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)
Life expectancy of at least 6 months at screening
SGOT (AST): ≤ 2.5 x ULN
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
SGPT (ALT): ≤ 2.5 x ULN
Patient is willing and able to comply with all protocol requirements

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 16
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
Therapy with estrogen within 4 weeks prior to the start of study drug
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
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)
medications for at least 4 weeks at the time of starting study drug/reference
History of adrenal gland dysfunction defined as requiring treatment for adrenal insufficiency
product will be eligible
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
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 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 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
Receipt of another investigational agent within 4 weeks or 5 x the treatment half-life, whichever is longer, of treatment start
Known hypersensitivity or allergy to abiraterone acetate, prednisone or any excipients in the study drugs
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
Other condition which, in the opinion of the Investigator, would preclude participation in this trial
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