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Protocol # 20-581

Status

Active, not recruiting

Description

The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-101 in combination with enzalutamide (Xtandi®) when administered to patients with metastatic prostate cancer progressing on enzalutamide.

Condition

  • Prostatic Neoplasms

Interventions

  • ORIC-101
  • enzalutamide 40 MG oral capsule [Xtandi]

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Recommended Phase 2 Dose (RP2D)
  • PSA Response Rate
  • PSA Progression
  • Number of Participants with Adverse Events
  • Number of Participants with Abnormal Laboratory Values
  • Number of Participants with Abnormal 12-lead ECG
  • Number of Participants with Abnormal Vital Signs

Secondary Outcome:

  • Maximum plasma concentration (Cmax)
  • Minimum plasma concentration (Cmin)
  • Time of maximum observed concentration (Tmax)
  • Area under the curve (AUC(0-24))
  • Elimination half-life (T1/2)
  • Circulating tumor cells (CTCs) conversion
  • Objective response rate (ORR)
  • Duration of response (DOR)
  • Progression-free survival (PFS)
  • Overall survival (OS)
  • Number of Participants with GR Expression by IHC

Enrollment

90

Study Start Date

October 28, 2019

Eligibility

  • Gender:     Male
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

ORIC Pharmaceuticals

Source

ORIC Pharmaceuticals

Official title

An Open-Label Phase 1b Study of ORIC-101 in Combination With Enzalutamide in Patients With Metastatic Prostate Cancer Progressing on Enzalutamide

Clinicaltrials.gov Identifier

NCT04033328

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.