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Metastatic Castration-resistant Prostate CancerPhase 3NCT04887506

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

A Phase 3 study testing TAVT-45, Zytiga and Prednisone in people with Metastatic Castration-resistant Prostate Cancer and Metastatic Castration-sensitive Prostate Cancer, run by Tavanta Therapeutics at 42 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
TAVT-45, Zytiga and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
42 sitesin 8 countries
Study dates
5 May 2021to 20 Oct 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 30Show fewer
  • 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)
  • Aspartate aminotransferase (AST): ≤ 2.5 x ULN
  • Alanine aminotransferase (ALT): ≤ 2.5 x ULN
  • Life expectancy of at least 6 months at screening
  • 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.
  • Patient is willing and able to comply with all protocol requirements

Who cannot join

  • 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
Show all 21Show fewer
  • 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.

Trial locations and contacts

42 sites in 8 countries.

42 sites in 8 countries

United States13 sites

  • Research Site

    Annapolis, Maryland, 21401

  • Research Site

    Bradenton, Florida, 34205

  • Research Site

    Denver, Colorado, 80211

  • Research Site

    Homewood, Alabama, 35209

  • Research Site

    Jeffersonville, Indiana, 47130

  • Research Site

    Little Rock, Arkansas, 72211

  • Research Site

    Los Angeles, California, 90048

  • Research Site

    Meridian, Idaho, 83642

  • Research Site

    New York, New York, 10016

  • Research Site

    San Bernardino, California, 92404

  • Research Site

    Troy, Michigan, 48084

  • Research Site

    Tucson, Arizona, 85715

  • Research Site

    Virginia Beach, Virginia, 23462

Other trials in United States

Spain10 sites

  • Research Site

    Barcelona, Sabadell, 08208

  • Research Site

    Barcelona, 08041

  • Research Site

    Barcelona, 08907

  • Research Site

    Lleida, 25198

  • Research Site

    Madrid, Arturo Soria, 270, 28033

  • Research Site

    Madrid, Av. Reyes Católicos 2, 28040

  • Research Site

    Madrid, Calle de Oña 10, 28050

  • Research Site

    Madrid, 28041

  • Research Site

    Manresa, Barcelona, 08243

  • Research Site

    Seville, 41013

Other trials in Spain

United Kingdom6 sites

  • Research Site

    Cheltenham, Gloucestershire, GL53 7AN

  • Research Site

    Glasgow, Scotland, G12 0YN

  • Research Site

    Guildford, Surrey, GU2 7XX

  • Research Site

    Hampstead, London, NW3 2QS

  • Research Site

    London, SW3 6JJ

  • Research Site

    Torquay, Devon, TQ2 7AA

Other trials in United Kingdom

Poland5 sites

  • Research Site

    Bydgoszcz, 85-048

  • Research Site

    Lublin, 20-718

  • Research Site

    Piaseczno, 05-500

  • Research Site

    Warsaw, Masovia, 02-351

  • Research Site

    Warsaw, 02-119

Other trials in Poland

Hungary3 sites

  • Research Site

    Budapest, 1062

  • Research Site

    Budapest, 1122

  • Research Site

    Debrecen, 4032

Other trials in Hungary

France2 sites

  • Research Site

    Brest, 29200

  • Research Site

    Suresnes, Hauts-de-Seine, 92151

Other trials in France

Sweden2 sites

  • Research Site

    Gothenburg, SE-413 45

  • Research Site

    Västerås, SE-721 89

Other trials in Sweden

Puerto Rico1 site

  • Research Site

    Ponce, 00731

Other trials in Puerto Rico

About this study

Official title: 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

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.

Read the 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)
Being tested
TAVT-45, Zytiga, Prednisone
Keywords
Prostate, Metastatic, Cancer
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAVT-45Drug

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

  • ZytigaDrug

    Also called Abiraterone Acetate

    500 mg tablet, two tablets administered once daily

  • PrednisoneDrug

    Also called Encorton

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

Study groups in NCT04887506
Study groupRoleWhat they receive
TAVT-45ExperimentalTAVT-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.
Receives: Drug: TAVT-45; Drug: Prednisone
Reference abiraterone acetate (Zytiga®) - R-AAActive comparatorZytiga (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.
Receives: Drug: Zytiga; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Average over Day 9 and Day 10

Secondary outcomes (3)

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

    This was a supplementary analysis of equivalence, with a between group comparison of serum testosterone for the Days 9 and10 average (rounded-up) values for mCSPC patients treated with either TAVT-45 or R-AA.

    Measured: Average over Day 9 and Day 10

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

    Supplementary analysis of equivalence of TAVT-45 and R-AA on Days 9 and 10 average (rounded-up) values in the mITT population (including mCRPC and mCSPC patients).

    Measured: Average over Day 9 and Day 10

  3. Percent of Subjects With PSA-50 Response, mITT

    The PSA-50 response is defined as a decrease of ≥ 50% in prostate-specific antigen (PSA) levels from baseline.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2021
  2. Study start5 May 2021
  3. Primary completion20 Oct 2022
  4. Study completion20 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04887506
Sponsor's protocol ID
TAVT45C02
Other IDs
2020-005611-46
Status last verified
Jan 2024
First submitted
6 May 2021
Last updated
16 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAVT-45, Zytiga and Prednisone in people with Metastatic Castration-resistant Prostate Cancer and Metastatic Castration-sensitive Prostate Cancer, run by Tavanta Therapeutics at 42 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Spain, United Kingdom, Poland, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Testosterone (ng/dL) Days 9 and 10 Average (Rounded-up), CR-ITT (time frame: Average over Day 9 and Day 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04887506.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.

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