Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Part A: Oral tablet(s), once or twice daily in 28 day cycles

Part B: Oral tablet(s), once or twice daily in 28 day cycles

Part A: Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment

Part B: Daily oral dosage and schedule at a recommended Phase 2 dose based on data from Part A

ARV-110

Phase 1/2 dose escalation study to assess the safety and tolerability of ARV-110 in men with mCRPC who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).

Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer

A Phase 1/2, Open-label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer

First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug

Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.

Overall RECIST response rate in patients with measurable disease at baseline.

To evaluate the clinical anti-tumor activity (PSA response rate per PCWG3, Overall RECIST RR, rPFS, and PFS) of ARV-110 in patients with mCRPC in different subgroups of patients with mCRPC with predefined tumor genomic and molecular profiles or based on prior therapy.

The anti-tumor activity of ARV-110 will be assessed by evaluating the overall PSA response per PCWG3.

The anti-tumor activity of ARV-110 will be assessed by evaluating the overall RECIST response rate.

The anti-tumor activity of ARV-110 will be assessed by evaluating the time to event progression free survival.

The anti-tumor activity of ARV-110 will be assessed by evaluating the duration of response.

The anti-tumor activity of ARV-110 will be assessed by evaluating the time to progression.

The anti-tumor activity of ARV-110 will be assessed by evaluating the overall survival.

PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).

PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter maximum concentration (Cmax).

PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter minimum concentration (Cmin).

PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)

From the date of first confirmed best overall response of CR or PR to the date of first progression per RECIST 1.1 or PCWG3, or death due to any cause without evidence of radiographic progression, whichever occurs first.

Time interval from the date of first ARV-110 dose to the date of death due to any cause.

Arvinas Androgen Receptor, Inc.

ARV-110 oral tablets in combination with abiraterone and a corticosteroid administered daily in 28 day cycles.

ARV-110 oral tablets in combination with abiraterone and a corticosteroid administered daily in 28 day cycles

ARV-110 in Combination with Abiraterone

Phase 1b study to assess the combination of ARV-110 and abiraterone in patients with metastatic prostate cancer with rising PSA values on abiraterone.

Trial of ARV-110 and Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

A Phase 1b Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-110 in Combination With Abiraterone in Patients With Metastatic Prostate Cancer

Dose limiting toxicities in first 4 weeks of the study combination treatment characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug

Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug combination

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.

Dose limiting toxicities in first 4 weeks of the study combination treatment will be assessed to determine the dose of ARV-110 and abiraterone associated with acceptable safety and tolerability.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer	NCT03888612	Prostate Cancer...	ARV-110	18 Years -	Arvinas Inc.
Trial of ARV-110 and Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)	NCT05177042	Prostate Cancer...	ARV-110 in Comb...	18 Years -	Arvinas Inc.

Spots Global Cancer Trial Database for bavdegalutamide