A Trial of SHR1258 in Patients With Biliary Tract Cancer

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Brief Title

A Trial of SHR1258 in Patients With Biliary Tract Cancer

Official Title

A Phase 2 Study of Pyrotinib in Patients With Advanced/ Metastatic HER2-Altered Biliary Tract Cancers Who Have Failed One or Two Prior Lines of Therapies

Brief Summary

      The study is being conducted to evaluate the efficacy and safety of SHR1258 in subjects with
      advanced/ metastatic HER2-altered biliary tract cancers
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective response rate

Secondary Outcome

 DOR

Condition

Biliary Tract Cancer

Intervention

SHR1258

Study Arms / Comparison Groups

 Treatment group
Description:  Intervention: Drug: SHR1258 400mg

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

70

Start Date

November 1, 2020

Completion Date

August 1, 2022

Primary Completion Date

May 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  enrollment into the study:

               1. Signed and dated written informed consent which is approved by Institutional
                  Review Board (IRB)/Ethics Committee (EC), willing and able to comply with
                  scheduled treatment, all examinations at study visits, and other study
                  procedures.

               2. Male or female, ≥18 years old.

               3. Histologically or cytologically confirmed (at a local laboratory) BTC

               4. Received up to two prior regimen of systemic therapy for advanced disease,
                  including 1 gemcitabine-containing regimen, and experienced disease progression
                  after or developed intolerance to the most recent prior therapy.

               5. Sufficient tumor tissue samples (archival or fresh biopsy samples) will be
                  provided by all subjects prior to the administration of pyrotinib (for
                  retrospective confirmation of HER2 alteration through a central laboratory if
                  applicable).

               6. Must have measureable disease per RECIST v1.1. The definition of CT or MRI
                  measurable lesion as the target lesion: according to RECIST v1.1, the long
                  diameter of such lesion should be ≥ 10 mm by the CT scan or the short diameter of
                  enlarged lymph nodes ≥ 15 mm.

               7. The laboratory test values must meet the functional level of important
                  organs/systems meets

               8. ECOG-PS (see Appendix 2): 0 - 1.

               9. If subjects have active hepatitis B virus (HBV) infection: HBV- deoxyribonucleic
                  acid (DNA) must be < 500 IU/mL and are willing to receive antiviral therapy
                  throughout the study; subjects with positive hepatitis C (HCV) ribonucleic acid
                  (RNA) must receive antiviral therapy in accordance with the local standard
                  treatment guideline and have ≤ CTCAE Grade 1 elevated hepatic function.

              10. Women of childbearing potential (WOCBP) must have a serum pregnancy test within 7
                  days before the first dose and the result is negative. WOCBP and male subjects
                  whose partners are WOCBP must agree to use effective contraception method during
                  the study period and within 8 weeks after the last dose of study medication.

        Exclusion Criteria:

          -  Inclusion Criteria:

        Subjects must meet all of the following inclusion criteria to be eligible for enrollment
        into the study:

          1. Signed and dated written informed consent which is approved by Institutional Review
             Board (IRB)/Ethics Committee (EC), willing and able to comply with scheduled
             treatment, all examinations at study visits, and other study procedures.

          2. Male or female, ≥18 years old.

          3. Histologically or cytologically confirmed (at a local laboratory) BTC

          4. Received up to two prior regimen of systemic therapy for advanced disease, including 1
             gemcitabine-containing regimen, and experienced disease progression after or developed
             intolerance to the most recent prior therapy.

          5. Sufficient tumor tissue samples (archival or fresh biopsy samples) will be provided by
             all subjects prior to the administration of pyrotinib (for retrospective confirmation
             of HER2 alteration through a central laboratory if applicable).

          6. Must have measureable disease per RECIST v1.1. The definition of CT or MRI measurable
             lesion as the target lesion: according to RECIST v1.1, the long diameter of such
             lesion should be ≥ 10 mm by the CT scan or the short diameter of enlarged lymph nodes
             ≥ 15 mm.

          7. The laboratory test values must meet the functional level of important organs/systems
             meets

          8. ECOG-PS (see Appendix 2): 0 - 1.

          9. If subjects have active hepatitis B virus (HBV) infection: HBV- deoxyribonucleic acid
             (DNA) must be < 500 IU/mL and are willing to receive antiviral therapy throughout the
             study; subjects with positive hepatitis C (HCV) ribonucleic acid (RNA) must receive
             antiviral therapy in accordance with the local standard treatment guideline and have ≤
             CTCAE Grade 1 elevated hepatic function.

         10. Women of childbearing potential (WOCBP) must have a serum pregnancy test within 7 days
             before the first dose and the result is negative. WOCBP and male subjects whose
             partners are WOCBP must agree to use effective contraception method during the study
             period and within 8 weeks after the last dose of study medication.

        Exclusion Criteria:

        Subjects presenting with any of the following will not be enrolled into the study:

          1. Prior receipt of HER2-targeted therapy.

          2. Concurrent anticancer therapy, other than the therapies being tested in this study.

          3. Radiation therapy administered within 2 weeks of first dose of study treatment.

          4. Laboratory values at screening outside the protocol-defined range.

          5. Clinically significant or uncontrolled cardiac disease.

          6. Target disease exclusion criteria:

        1) Malignant tumors with other pathological types, such as mixed cancer, double primary
        cancers.

        2) Medical history of other active malignancies within last 5 years. 3) Subjects with
        active central nervous system (CNS) metastases are excluded. Subjects with history or
        evidence of current leptomeningeal metastases are excluded.

        4) By the date of first dose of study treatment, the washout period of previous drug
        treatment / medical intervention does not meet the following requirements 7. Medical
        history exclusion criteria:

          1. Severe cardiac disease

          2. Prior to the first dose of study treatment, patients with the following conditions:
             inability to swallow, chronic diarrhea, intestinal obstruction, gastrointestinal
             perforation or gastrectomy, colitis or other diseases or special conditions that
             affect drug administration and absorption.

          3. Prior to the first dose of study treatment, patients with severe effusions with
             clinical symptoms

          4. Symptoms of severe infection or evidence for microbiological/viral diagnosis.

          5. Congenital or acquired immunodeficiency (e.g., human immunodeficiency virus [HIV]
             infection).

        8. History of allergy to the study drugs or components. 9. Pregnancy or breastfeeding. 10.
        Concomitant treatments exclusion criteria:

          1. Within 2 weeks prior to the first dose of study treatment, or during the study period,
             patients receive or are anticipated to receive continuous strong CYP3A4 inducers or
             inhibitors, P-gp inhibitors.

        11. Others:

          1. Per investigator's judgment, other diseases or laboratory evidence that would cause
             serious threats to the safety of the patients, or which are not in the best interest
             of the patient to participate in the study are excluded

          2. Per investigator's judgment, other situations that may confuse the study results or
             would affect the subjects' ability to comply with study procedures are excluded, such
             as alcoholism, drug abuse, criminal detention, etc.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT04571710

Organization ID

HR-BLTN-II-BTC


Responsible Party

Sponsor

Study Sponsor

Jiangsu HengRui Medicine Co., Ltd.


Study Sponsor

, , 


Verification Date

September 2020