Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Amino Acids

Androgens

Androgen Antagonists

Asparagine

The dose of ASN001 will be based on the assigned study group. The initial dose level of ASN001 will be 50 mg daily. After a safety review, the dose may be escalated for the next group of subjects. Additional dose levels are 100 mg, 200 mg, 300 mg, and 400 mg.

ASN001: Escalating dose Part A

Niranjan Rao, PhD

This study will be conducted in three parts. Part A is a dose-escalation study to determine two safe and tolerable doses of ASN001 for men with metastatic castration resistant prostate cancer. Part A will also characterize the pharmacokinetics and pharmacodynamics of the ASN001 through blood sampling. Subjects in Part B will receive one of two doses identified in Part A to determine which one is more effective, and collect additional pharmacokinetic data. Part C is an extension for subjects completing either Part A or B.

Parts A and B will include a screening period (up to 28 days) and a 12-week treatment period. A subject with no serious adverse drug reactions and who is expected to benefit from continued treatment in the opinion of the investigator will have the opportunity to participate in the long-term extension (Part C). If the subject is not a candidate for or chooses not to participate in the long-term extension (Part C), a post-treatment period of 4 weeks will commence that concludes with an end-of-study visit.

Subjects participating in only Part A or Part B will have approximately 9 study site visits over 18 weeks. Part C will include monthly visits to the study site for 9 months. Thereafter, visits will occur every 3 months. A subject with stable disease or response may continue ASN001 treatment with the approval of the investigator; treatment can continue until a subject experiences an intolerable adverse event (AE) or disease progression, withdraws consent or until termination of the study by the sponsor. At the end of treatment, a post-treatment period of 4 weeks will commence that concludes with an end-of-study visit.

Part B of the study will not be completed as enrollment was halted after Part A (Phase 1)

Safety, Preliminary Efficacy and Pharmacokinetics of ASN001 in Metastatic Castrate Resistant Prostate Cancer

A Phase 1/2, Open-Label, Uncontrolled, Multiple-Dose Escalation, Cohort Expansion And Extension Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of ASN001 In Subjects With Metastatic Progressive Castrate Resistant Prostate Cancer

To evaluate the effects of ASN001 on the concentration of serum bone-specific alkaline phosphatase (BAP)

Effects on Luteinizing hormone, follicle stimulating hormone, cortisol, adrenocorticotropic hormone, deoxycorticosterone, corticosterone, dehydroepiandrosterone (DHEA), DHEA sulfate, testosterone and dihydrotestosterone

The MTD will be determined by evaluating the number of subjects with treatment related dose limiting toxicity.

Measure of safety, tolerability and preliminary efficacy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety, Preliminary Efficacy and Pharmacokinetics of ASN001 in Metastatic Castrate Resistant Prostate Cancer	NCT02349139	Cancer of the P... Neoplasms, Pros... Prostate Cancer Prostatic Cance... Neoplasms, Pros... Prostate Neopla...	ASN001: Escalat...	18 Years -	Asana BioSciences
Safety, Preliminary Efficacy and Pharmacokinetics of ASN001 in Metastatic Castrate Resistant Prostate Cancer	NCT02349139	Cancer of the P... Neoplasms, Pros... Prostate Cancer Prostatic Cance... Neoplasms, Pros... Prostate Neopla...	ASN001: Escalat...	18 Years -	Asana BioSciences
Safety, Preliminary Efficacy and Pharmacokinetics of ASN001 in Metastatic Castrate Resistant Prostate Cancer	NCT02349139	Cancer of the P... Neoplasms, Pros... Prostate Cancer Prostatic Cance... Neoplasms, Pros... Prostate Neopla...	ASN001: Escalat...	18 Years -	Asana BioSciences

Spots Global Cancer Trial Database for asn001: escalating dose part a