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NeoplasmPhase 1NCT02759666

A Phase I Trial of SHR3162 in Subjects With Advanced Solid Tumors

A Phase 1 study testing SHR3162 in people with Neoplasm and Solid Tumors, run by Atridia Pty Ltd. at 3 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, multicenter, non-randomized, dose-escalation phase 1 trial to evaluate the safety and tolerability of SHR3162 in participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm, Solid Tumors
What is being tested?
SHR3162
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesAustralia
Study dates
1 Jun 2016to 26 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and/or females over age 18.
  • Ability to understand the purposes and risks of the trial and his/her signed informed consent form approved by Human Research Ethics Committee (HREC) of the trial site was obtained before the entering the trial.
  • Histologically or cytologically confirmed advanced or metastatic solid tumor for which no established standard therapy is available.
  • At least one measurable lesion by CT or MRI according to RECIST Version 1.1, which is not in irradiated area (only for expansion phase).
  • Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in case of alopecia, Grade 2 is acceptable).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • Life expectancy of at least 3 months.
  • Acceptable liver function defined below:
  • Total bilirubin ≤1.5 times upper limit of normal (ULN);
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN; however, ≤5 times ULN in a participant who has liver metastases or is treated with biliary drainage
  • Acceptable renal function defined below:
  • Serum creatinine ≤1.5 times ULN or calculated creatinine clearance (by the Cockcroft-Gault formula) ≥60 mL/minutes
  • Acceptable coagulation status defined below:
  • Prothrombin time <1.3 times ULN
  • Partial thrombin time <1.3 times ULN
  • Acceptable hematologic status (without hematologic supports including hematopoietic factor, blood transfusion) defined below:
  • Absolute neutrophil count (ANC) ≥1500/μL
  • Platelet count ≥100000/μL
  • Hemoglobin ≥9.0 g/dL
  • No clinically significant abnormalities in urinalysis.
  • Female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.

Who cannot join

  • Hematologic malignancies.
  • 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.
  • Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery.
  • Percutaneous coronary intervention conducted within 6 months prior to the trial entry for cardiac infarction or angina pectoris.
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  • Seizure disorders requiring anticonvulsant therapy.
  • Taking a medication that prolongs QT interval and has a risk of Torsade de Pointes, or a history of long QT syndrome.
  • Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
  • Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), hormone therapy, or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry, and ever use PARP inhibitor.
  • Participation in an investigational drug or device trial within 4 weeks prior to the trial entry.
  • Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  • Recent venous thrombosis (including deep vein thrombosis or pulmonary embolism within 1 year of study).
  • History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis.
  • Subject is pregnant (positive serum beta human chorionic gonadotropin [β-HCG] test at screening) or is currently breast-feeding, their partner anticipates becoming pregnant/impregnating during the trial or within 6 months after receiving the last dose of trial treatment.
  • History of organ allograft, autologous stem cell transplantation, or allogeneic -
  • Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.
  • Unwillingness or inability to comply with the trial protocol for any reason.
  • Legal incapacity or limited legal capacity.
  • Known drug abuse or alcohol abuse.

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • Border Medical Oncology

    Albury, New South Wales, 2640

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Linear

    Melbourne

Other trials in Australia

About this study

Official title: A Multicenter, Open-Label, Phase 1 Trial of SHR3162 Given Orally to Subjects With Advanced Solid Tumors

This is an open-label, multicenter, non-randomized, dose-escalation phase 1 trial to evaluate the safety and tolerability of SHR3162 in participants with advanced solid tumors.

Read the detailed description

Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) is a family of proteins that plays important roles in multiple cellular processes, including single-strand DNA breaks, which if left unrepaired, leads to double-strand breaks (DSB) during DNA replication. The DSB can be repaired either through error-free homologous recombination (HR) or error-prone non-homology end joining. In HR deficient cancer cells with mutations on HR genes such as BRCA1, BRCA2 or partner and localizer of BRCA2 (PALB2), DSB cannot be efficiently and correctly repaired, resulting in cell death. Viable cells, on the other hand, have normal HR and do not replicate as often as cancer cells; thus they can survive PARP inhibition. PARP inhibitors are being actively developed worldwide as promising anti-tumor therapeutics. The current trial will be conducted in participants with advanced solid tumors for whom satisfactory treatments are not yet available.

In the dose-escalation phase, patients will be enrolled sequentially into the 8 dose levels of SHR3162 designated in this study(3-6 patients per cohort). One to two sentinel participants in Cohort 1 who will be treated and closely monitored for 24 hours. If no adverse effects are noted during the 24-hour period, dosing of further participants in the cohort may continue.

In the dose expansion part of the study, up to 12 additional participants will be enrolled at the MTD.

Being tested
SHR3162
Keywords
PARP, advanced solid tumor
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR3162Drug

    Also called Fluzoparib

    SHR3162 capsule(s) is administered orally QD.

Study groups in NCT02759666
Study groupRoleWhat they receive
SHR3162Experimental3 to 6 participants (traditional "3+3" design) will be enrolled in 6 dose levels. SHR3162 was administered once daily in dose levels 1 and 2 and will be administered twice daily in dose levels 3 to 6.
Receives: Drug: SHR3162

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD)

    MTD will be defined as the maximum dose level at which no more than one 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing

    Measured: 4 weeks

Secondary outcomes (6)

  1. Number of participants with treatment-emergent adverse events

    Measured: 24 months

  2. Peak plasma concentration (Cmax)

    Measured: 4 weeks

  3. Area under the plasma concentration versus time curve (AUC）

    Measured: 4 weeks

  4. T1/2 (half-life)

    Measured: 4 weeks

  5. Clearance (CL)

    Measured: 4 weeks

  6. Volume of distribution at steady state (Vss)

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2016 (estimated)
  2. Study start1 Jun 2016
  3. Primary completion8 Mar 2019
  4. Study completion26 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02759666
Sponsor's protocol ID
SHR3162-002
Status last verified
Sep 2019
First submitted
29 Apr 2016
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR3162 in people with Neoplasm and Solid Tumors, run by Atridia Pty Ltd. at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02759666.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.

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