A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC

NCT03741712 | Terminated Phase 1 DMC

• 1 other identifier: SHR2554-SHR3680-I/II-102
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to study the tolerance, pharmacokinetics (PK) and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer.

Conditions

Prostate Cancer; Castration-resistant Prostate Cancer

Keywords

Castration-resistant Prostate Cancer; SHR2554; SHR3680

Outcome Measures

Primary Outcomes (3)

• DLT

  A DLT is any of the predefined set of unacceptable adverse events observed and at least possibly related to investigational agents

  Approximately 12 months

• MTD

  The first cycle DLTs will be utilized to determine the MTD and future dose escalations or de-escalations The first cycle DLTs will be utilized to determine the MTD and future dose escalations or de-escalations

  Approximately 12 months

• PSA response rate

  After the continuous therapy from randomisation to the end of the 12 weeks, the ratio of patients whose levels of PSA decreased more than 50%

  Approximately 12 weeks

Secondary Outcomes (5)

• Time to PSA progression

  Approximately 70 months

• Objective response rate (ORR)

  Approximately 70 months

• Under the Curve (AUC)

  Approximately 12 months

• Maximum Observed Plasma Concentration (Cmax)

  Approximately 12 months

• Adverse events (AE)

  Approximately 70 months

Study Arms (2)

SHR2554

EXPERIMENTAL

Participants will receive SHR2554 orally

Drug: SHR2554

SHR2554+SHR3680

EXPERIMENTAL

Participants will receive SHR2554 combined with SHR3680 orally

Drug: SHR3680; Drug: SHR2554

Interventions

SHR3680 DRUG

Tablet. Specifications of 80mg

SHR2554+SHR3680

SHR2554 DRUG

Tablet. Specifications of 50mg and 200mg

SHR2554; SHR2554+SHR3680

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed prostate cancer;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
• Radiographic evidence of metastasis;
• Sustained therapy of luteinizing hormone-releasing hormone analogue（LHRHA）or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of LHRHA;
• Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
• Adequate hepatic, renal, heart, and hematological functions;
• Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

You may not qualify if:

• Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immunotherapy, and endocrinotherapy;
• Planned to initiate any other anti-tumor therapies during the study;
• Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
• Clinically significant cardiovascular diseases;
• History of seizure or certain conditions that may predispose to seizure;
• Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Dingwei Ye, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: November 15, 2018
• Study Start: November 20, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 8, 2020
• Last Updated: February 5, 2021

Record last verified: 2018-07

Locations

CN (1)