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Trial record 5 of 22 for:    cancer | First posted from 04/21/2016 to 04/21/2016

A Phase 1 Trial of SHR3680 in Prostate Cancer as Monotherapy

This study is currently recruiting participants.
Verified January 2017 by Atridia Pty Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02747342
First Posted: April 21, 2016
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Atridia Pty Ltd.
  Purpose
This is a multicenter, dose-escalation phase 1 trial to evaluate the safety and tolerability of SHR3680 given orally to subjects with metastatic castration-resistant prostate cancer (mCRPC) as monotherapy.

Condition Intervention Phase
Neoplasm Prostate Cancer Drug: SHR3680 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of SHR3680 in Subjects With Metastatic Castration-Resistant Prostate Cancer as Monotherapy

Resource links provided by NLM:


Further study details as provided by Atridia Pty Ltd.:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: 4 weeks ]
    MTD is defined as the maximum dose level at which no more than 1 out of 3 participants experience a DLT within the first 4 weeks of multiple dosing


Secondary Outcome Measures:
  • Number of participants with treatment-emergent adverse events [ Time Frame: 24 months ]
  • Peak plasma concentration (Cmax) [ Time Frame: 4 weeks ]
  • Area under the plasma concentration-time curve (AUC) [ Time Frame: 4 weeks ]
  • T1/2 (half-life) [ Time Frame: 4 weeks ]
  • Percentage of participants reaching at least a 50% reduction in prostate specific antigen (PSA) at Week 12 as compared to baseline [ Time Frame: 12 weeks ]
  • Time to PSA progression [ Time Frame: 24 months ]
  • Objective response rate (ORR) [ Time Frame: 24 months ]
  • Radiological progression-free survival (PFS) [ Time Frame: 24 months ]

Estimated Enrollment: 42
Actual Study Start Date: September 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SHR3680
SHR3680 will be administered orally at the starting dose of 40 mg/day.
Drug: SHR3680
SHR3680 will be administered orally at the starting dose of 40 mg/day.

Detailed Description:

This study consists of 2 phases. In the dose escalation phase, up to 6 dose levels of SHR3680 (40 mg/day, 80 mg/day, 160 mg/day, 240 mg/day, 360 mg/day, 480 mg/day) will be investigated with a sequential "3+3" design (3 or 6 participants in each dose level). There will be a single-dose pharmacokinetic (PK) run-in period (7 days). Following the first dose, participants will enter a 1 week treatment-free period to evaluate safety and single-dose PK. If not dose-limiting toxicities (DLTs) are observed during the 1-week period, SHR3680 administration will resume at the same dose level.

In the expansion phase, up to 12 additional participants will be enrolled at the MTD or recommended phase 2 dose (RP2D). The purpose of the expansion part of the study is to explore the clinical benefits of SHR3680 and to further identify its PK features.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Male 18 years or older.
  2. Ability to understand the purposes and risks of the trial and his signed informed consent form approved (ICF) by the Human Research Ethics Committee (HREC) of the trial site and obtained before entering the trial
  3. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
  4. For patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial.
  5. Serum testosterone level <1.7 nmol/L (50 ng/dL) at the screening visit.
  6. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration).
  7. Progressive disease by PSA or imaging after docetaxel-based chemotherapy in the setting of medical or surgical castration. Prior enzalutamide is allowed as long as patients had a PSA response >50% or were treated for at least 6 months. Disease progression for study entry is defined as one or more of the following 3 criteria:

    • PSA progression defined by a minimum of three rising PSA levels with an interval of ≥1 week between each determination. The PSA value at the Screening visit should be ≥2 ng/mL.
    • Soft tissue disease progression defined by RECIST.
    • Bone disease progression defined by two or more new lesions on bone scan
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  9. Life expectancy of at least 6 months.
  10. Able to swallow the study drug and comply with the study requirements.
  11. Acceptable liver function defined below:

    • Total bilirubin ≤1.5 times upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2 times ULN; however, ≤5 times ULN in a participant who has liver metastases or treated with biliary drainage.
  12. Acceptable renal function: serum creatinine ≤1.5 times ULN.
  13. Acceptable hematologic status (without hematologic support including hematopoietic factor, blood transfusion) defined below:

    • Absolute neutrophil count (ANC) ≥1500/μL
    • Platelet count ≥100,000/μL
    • Hemoglobin ≥9.0 dL

Exclusion Criteria:

  1. Treatment with androgen receptor antagonists (enzalutamide, bicalutamide, flutamide, nilutamide), 5-alpha reductase inhibitors (finasteride, dutasteride), estrogens, or chemotherapy within 4 weeks of enrollment (Day 1 visit) or plans to initiate treatment with any of these drugs during the study. Ongoing therapy with biphosphonates or Rank Ligand inhibitors are acceptable.
  2. Treatment with therapeutic immunizations for prostate cancer (e.g.,PROVENGE®) or plans to initiate treatment with any of these treatments during the study.
  3. Metastases in the brain or active epidural disease (Note: patients with treated epidural disease are allowed).
  4. Use of herbal products that may PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks of enrollment (day 1 visit) or plans to initiate treatment with any of these therapies during the study.
  5. History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer.
  6. Radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks) and radionuclide therapy within 8 weeks of enrollment (Day 1 visit).
  7. Have used or plan to use from 30 days prior to enrollment (day 1 visit) through to the end of the study medications known to lower the seizure threshold or prolong the QT interval.
  8. Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
  9. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
  10. History of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attack within 12 months of enrollment (Day 1 visit), or any condition that may pre-dispose to seizure.
  11. Use of an investigational agent within 4 weeks of enrollment or plans to initiate treatment with an investigational agent during the study.
  12. Major surgery, other than diagnostic surgery, within 4 weeks prior to trial entry, without complete recovery.
  13. Gastrointestinal disorder affecting absorption.
  14. Structurally unstable bone lesions suggesting impending fracture.
  Contacts and Locations
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): NCT02747342


Contacts
Contact: Kathy You, MD, PhD +61 02 9299 0433 kathyyou@atridia.com
Contact: Stacey Luo, PharmD staceyluo@shhrp.com

Locations
Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Lisa Horvath         
St George Hospital Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Carole Harris         
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Paul D'Souza         
Sponsors and Collaborators
Atridia Pty Ltd.
  More Information

Responsible Party: Atridia Pty Ltd.
ClinicalTrials.gov Identifier: NCT02747342     History of Changes
Other Study ID Numbers: SHR3680-002
First Submitted: April 19, 2016
First Posted: April 21, 2016
Last Update Posted: June 8, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Atridia Pty Ltd.:
Metastatic castration-resistant prostate cancer
Monotherapy

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