Phase 3 study investigating the efficacy and safety of TAVT-45 (abiraterone acetate) Granules for Oral Suspension (a novel abiraterone acetate formulation) relative to a reference abiraterone acetate formulation in patients with metastatic Castrate Sensitive Prostate Cancer (mCSPC) and metastatic Castrate Resistant Prostate Cancer (mCRPC).

Tavanta Therapeutics, Inc.0 sites108 target enrollmentApril 17, 2021

ConditionsMetastatic 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]

DrugsZytiga

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic Castrate Sensitive Prostate Cancer (mCSPC) and metastatic Castrate Resistant Prostate Cancer (mCRPC)
Sponsor: Tavanta Therapeutics, Inc.
Enrollment: 108
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 17, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Tavanta Therapeutics, Inc.

Eligibility Criteria

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:

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 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.
•4\. Therapy with estrogen within 4 weeks 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