Phase 3 study to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer

Phase 1

• Conditions: Metastatic Castrate Sensitive Prostate Cancer (mCSPC) and metastatic Castrate Resistant Prostate Cancer (mCRPC); MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005611-46-ES
• Lead Sponsor: Tavanta Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-06
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 108

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, as defined below:
a). CSPC: Using the American Joint Committee on Cancer (AJCC) tumor, node, metastasis (TNM) system, patients must have Tany Nany M+ (distant metastases) disease AND two of the following:
-Gleason score of 8 or greater
-Three or more bone scan lesions
-Measurable visceral metastases
b). CRPC: Patients must have metastatic* disease, and must also have disease progression according to the recommendations of the Prostate Cancer Working Group 3 by having at least one of the following criteria:
-Two rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 1 ng/mL
-Imaging progression (CT/MRI) by RECIST 1.1 criteria or PET/CT*
-Nuclear scan progression by 2 or more new bone lesions.
*Note: Metastatic disease should be documented by MRI/CT, PET/CT (including, but not limited to, standard of care imaging using 18F-fluciclovine, 11C-choline, or PSMA where approved) or bone scan. Imaging obtained within 90 days prior to the start of study drug/reference product will be accepted.
6. The following prior treatment and or surgery for prostate cancer are allowed:
a) CSPC:
i) 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
ii) 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
iii) Radiation or surgical therapy that was not initiated 4 weeks after the start of ADT or orchiectomy
b) CRPC:
i). Previous chemotherapy with docetaxel for metastatic disease with treatment completed at least 1 year prior to enrolment
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 CYP3A4 inducers at prior to start of study medication
9. Discontinuation of radiotherapy prior to start of study medication
10. Discontinuation of supplements (herbal and mineral) 30 days prior to the first dose of study medication and for the duration of the trial. Use of a basic multi-vitamin is allowed.
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:
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)
SGOT (AST): = 2.5 x ULN
SGPT (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. Patie

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:
a) Prior treatment with abiraterone or enzalutamide is prohibited
b) Previous chemotherapy is prohibited with exception of docetaxel treatment as specified in the inclusion criteria 6.
3. Initiation of bisphosphonate or denosumab therapy within 30 days prior to the start of study drug/reference product. Patients who are on a stable dose of these medications for at least 30 days at the time of starting study drug/reference product will be eligible.
4. Therapy with estrogen within 30 days 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, non-muscle 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 30 days 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 HbA1c > 8% within the past 12 months
13. Uncontrolled hypertension (stage 3 hypertension or greater as defined as blood pressure greater than 179 mm Hg systolic or 109 mm Hg diastolic at enrollment)
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. Other condition which, in the opinion of the Investigator, would preclude participation in this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified