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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02747342




Registration number
NCT02747342
Ethics application status
Date submitted
19/04/2016
Date registered
21/04/2016

Titles & IDs
Public title
A Phase 1 Trial of SHR3680 With or Without SHR3162 in Prostate Cancer
Scientific title
A Phase 1 Trial of SHR3680 With or Without SHR3162 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
SHR3680-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasm 0 0
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR3680; SHR3162

Experimental: SHR3680; SHR3680+SHR3162 - In dose esclation and expansion phase, SHR3680 will be administered orally In combination phase, SHR3680 will be administered together with SHR3162


Treatment: Drugs: SHR3680; SHR3162
SHR3680 will be administered orally in dose escalation/expansion phase,

SHR3680 will be administered orally at a fixed dose together with SHR3162 in combination phase.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum tolerated dose (MTD)
Timepoint [1] 0 0
4 weeks
Primary outcome [2] 0 0
Recommended Phase 2 doses (RP2Ds)
Timepoint [2] 0 0
24 months
Secondary outcome [1] 0 0
Number of participants with treatment-emergent adverse events
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
The AUC of SHR3680 and SHR3162 (area under the curve)
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
The cMax (peak plasma concentration) of SHR3680 and SHR3162
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
PSA reduction
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
PSA progression
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Objective response rate (ORR)
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Radiological progression-free survival (PFS)
Timepoint [7] 0 0
24 months

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Male 18 years and older
2. Ability to understand the purposes and risks of the trial and his/her signed informed consent form approved by the HREC of the trial site, which must be 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 or abiraterone 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 by one or more of the following three 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 µg/L (2 ng/mL)
* Soft tissue disease progression defined by RECIST (Appendix A)
* Bone disease progression defined by two or more new lesions on the bone scan
8. 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 study requirements
11. Acceptable liver function defined as:

* Total bilirubin = 1.5 times the upper limit of normal range (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 times ULN; however, = 5 times ULN in a subject who has liver metastases or has been treated with biliary drainage
12. Acceptable renal function defined below:

• Serum creatinine = 1.5 times ULN
13. Acceptable hematologic status (without hematologic support including hematopoietic factor, blood transfusion) defined below:

* Absolute neutrophil count (ANC) = 1,500/µL
* Platelet count = 100,000/µL
* Hemoglobin = 9.0 g/dL
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Treatment with AR antagonists (enzalutamide, bicalutamide, flutamide, nilutamide), 5-a 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 bisphosphonates or Rank Ligand inhibitors are acceptable.
2. Prior treatment with a PARP inhibitor or have plans to initiate treatment with a PARP inhibitor during the study (only apply to subjects participating in Part 2b)
3. Treatment with therapeutic immunizations for prostate cancer (e.g., PROVENGE®) or plans to initiate treatment with any of these therapies during the study
4. Metastases in the brain or active epidural disease (Note: patients with treated for epidural disease are allowed to enter the trial)
5. Use of herbal products that may decrease 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
6. History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
7. Radiation therapy within 3 weeks (if single fraction of radiotherapy, then a 1-week gap is allowable) and radionuclide therapy within 8 weeks of enrollment (Day 1 visit). Any radiotherapy-related AE > Grade 1 before the start of study treatment.
8. 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 (described in Appendix I)
9. 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
10. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment
11. 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 (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization)
12. Use of an investigational agent within 4 weeks of enrollment or plans to initiate treatment with an investigational agent during the study
13. Major surgery, other than diagnostic surgery, within 4 weeks prior to trial entry, without complete recovery
14. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within the last 3 months)
15. Structurally unstable bone lesions suggesting impending fracture

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2020
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Westmead Hospital - Sydney
Recruitment hospital [6] 0 0
Icon Cancer Centre - South Brisbane
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2145 - Sydney
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02747342