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

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ClinicalTrials.gov Identifier: NCT03741712
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Castration-resistant Prostate Cancer Drug: SHR3680 Drug: SHR2554 Phase 1 Phase 2

Detailed Description:
This is a multicenter, open, non-randomized and dose-escalating and -expansion Phase I/II trial and it studies the tolerance, PK and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer. The Phase I part is a dose-escalating study including Ia (dose-escalation monotherapy) and Ib (dose-escalation combination therapy). Approximately 18-30 patients in Phase Ia will only receive one of five dose levels of orally SHR2554. Approximately 30~48 patients in Phase Ib trial will receive SHR2554 combined with SHR3680, in which 2~3 different dose levels of SHR2554 will be selected based on the result of the Phase Ia. Phase II part is a dose-expansion study. Primary endpoints of the study are dose-limiting tolerance (DLT), maximum-tolerated dose (MTD) and prostate specific antigen (PSA) response rate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II,Open-Label,Does-Escalation and -Expansion, Safety,Pharmacokinetics and Efficacy Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of Patients With Metastatic Castration Resistant Prostate Cancer
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : July 8, 2020
Estimated Study Completion Date : July 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: SHR2554
Participants will receive SHR2554 orally
Drug: SHR2554
Tablet. Specifications of 50mg and 200mg

Experimental: SHR2554+SHR3680
Participants will receive SHR2554 combined with SHR3680 orally
Drug: SHR3680
Tablet. Specifications of 80mg

Drug: SHR2554
Tablet. Specifications of 50mg and 200mg




Primary Outcome Measures :
  1. DLT [ Time Frame: Approximately 12 months ]
    A DLT is any of the predefined set of unacceptable adverse events observed and at least possibly related to investigational agents

  2. MTD [ Time Frame: Approximately 12 months ]
    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

  3. PSA response rate [ Time Frame: Approximately 12 weeks ]
    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%


Secondary Outcome Measures :
  1. Time to PSA progression [ Time Frame: Approximately 70 months ]
    Time from randomisation to the first time of PSA progression according to the criteria of the Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

  2. Objective response rate (ORR) [ Time Frame: Approximately 70 months ]
    The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

  3. Under the Curve (AUC) [ Time Frame: Approximately 12 months ]
    The single dose and multiple dose PK will be calculated as data permits including Area AUC

  4. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Approximately 12 months ]
    The single-dose and multiple dose PK will be calculated as data permits including Cmax

  5. Adverse events (AE) [ Time Frame: Approximately 70 months ]
    The type, frequency, severity, timing, seriousness, and relationship to study therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed prostate cancer;
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
  3. Radiographic evidence of metastasis;
  4. 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;
  5. Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
  6. Adequate hepatic, renal, heart, and hematological functions;
  7. 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741712


Contacts
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Contact: Chunlei Jin, Ph.D. 86-021-23511999 jinchunlei@hrglobe.cn

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China
Contact: Dingwei Ye, M.D.         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Dingwei Ye, M.D. Fudan University

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03741712     History of Changes
Other Study ID Numbers: SHR2554-SHR3680-I/II-102
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Castration-resistant Prostate Cancer
SHR2554
SHR3680

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases