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

Completed · Phase 3

Conditions studied: Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer, Metastatic Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04887506

Run by

Tavanta Therapeutics

People needed

107

Starts

2021-05-05

Expected to finish

2022-10-20

Last updated by the study team

2024-01-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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
• 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:
• 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)

You may not qualify if…

• 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.
• 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.
• 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
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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