PT-112 (Phosplatin’s Platinum) Combine With Gemcitabine Injection for Advanced Solid Tumors

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Brief Title

PT-112 (Phosplatin's Platinum) Combine With Gemcitabine Injection for Advanced Solid Tumors

Official Title

An Open-label Phase I/II Clinical Trial of PT-112 Combine With Gemcitabine Injection for Advanced Solid Tumors

Brief Summary

      Phase I dose escalation period: solid tumors, including but not limited to biliary tract
      cancer, pancreatic cancer, ovarian cancer, thymoma, neuroendocrine carcinoma and other
      advanced solid tumors.

      Phase II trial period: biliary tract cancer
    

Detailed Description

      This is a multicenter, open-label, phase I/ II clinical study, including phase I dose
      escalation period and phase II trial period.

      The phase I dose escalation period will adopt a 3+3 dose escalation design. Three dose groups
      are designed as follows:

      Level 1: 150 mg/m2 PT-112 (Phosplatin's platinum) + 1000 mg/m2 gemcitabine; Level 2: 200
      mg/m2 PT-112 + 1000 mg/m2 gemcitabine; Level 3: 250 mg/m2 PT-112 + 1000 mg/m2 gemcitabine. If
      any DLT(Dose-Limiting Toxicity ) occurs in Level 1 group during dose escalation, the dose
      will be down titrated to Level-1 150 mg/m2 PT-112 + 800 mg/m2 gemcitabine. After the lowest
      dose group (Level-1 or Level 1), the dose of gemcitabine will be fixed while the dose of
      PT-112 will be up titrated.

      During the phase I dose escalation period, sufficient data will be obtained to demonstrate
      that the dose is safe. Investigators and sponsor will discuss and decide the initiation time
      of the phase II period. In phase II, it is planned to enroll subjects with biliary tract
      cancer according to Simon's two-stage study design, to assess the safety and anti-tumor
      efficacy of PT-112 in combination with gemcitabine for treating patients with advanced
      biliary tract cancer. In the first period, 23 evaluable subjects are intended to be enrolled.
      If ≤ 12 subjects have disease control (CR(Complete Response) + PR(Partial Response) +
      SD(Stable Disease)) at the first post-baseline tumor assessment, the study drug will be
      considered to be ineffective and the trial terminated; if >12 subjects have disease control
      (CR + PR + SD), the enrollment for phase II will be initiated. In total, 37 evaluable
      subjects will be enrolled. The study drug will be considered to be ineffective if a total of
      ≤23 subjects have disease control (CR + PR + SD).
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Define the recommended dose level for PT-112(Phase I)

Secondary Outcome

 Anti-tumor efficacy evaluation (Phase I)

Condition

Biliary Tract Cancer

Intervention

PT-112

Study Arms / Comparison Groups

 PT-112 in Combination with Gemcitabine Injection
Description:  PT-112 in combination with Gemcitabine injection for the treatment of patients with advanced solid tumors

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

68

Start Date

April 13, 2020

Completion Date

April 28, 2023

Primary Completion Date

August 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female aged 18-75 years (18 and 75 years included).

          2. For phase I dose escalation period only: patients with locally advanced or metastatic
             solid tumors (including but not limited to biliary tract cancer, pancreatic cancer,
             ovarian cancer, etc.) confirmed by histopathology or cytology who have failed to
             respond to standard regimen or have no standard regimen.

          3. ECOG(Eastern Cooperative Oncology Group) performance status score of 0-1.

          4. Expected survival time greater than 12 weeks.

          5. Subjects must have proper organ function and laboratory test results meet the
             following standards prior to enrollment:

               -  Basically normal bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 ×
                  109/ L, platelet ≥ 100 × 109/ L, and hemoglobin ≥ 90 g/ L;

               -  Basically normal liver function: serum albumin ≥ 3.0 g/dL; bilirubin ≤ 1.5 ×
                  ULN(upper limit of normal ), ALT(Alanine aminotransferase) and AST( Aspartate
                  transaminase) ≤ 2.5 × ULN; if the patients suffer from liver metastasis or
                  primary liver cancer, ALT or AST ≤ 5 × ULN;

               -  Normal renal function: creatinine ≤ 1.5 × ULN or creatinine clearance (CL) ≥ 60
                  mL/min (according to Cockcroft-Gault formula); .Basically normal coagulation
                  function: INR(international normalized ratio) ≤ 1.5 × ULN, APTT(activated partial
                  thromboplastin time) ≤ 1.5 × ULN.

          6. Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%.

          7. subjects with a history of brain metastases who are diagnosed as stable disease by the
             investigator and do not require additional steroids or anticonvulsants, with
             radiotherapy or without treatment.

          8. Negative serum β-HCG(human chorionic gonadotropin) test for women of childbearing
             potential (defined as women aged less than 50 years or over 50 years and amenorrheic
             for less than 12 months prior to screening).

          9. Subjects must give informed consent for the study prior to the test and sign the
             informed consent form.

             Additional inclusion criteria applicable to phase II trial period:

         10. Patients with histologically or cytologically confirmed unresectable or metastatic
             biliary tract cancer, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic
             cholangiocarcinoma (EHCC), and gallbladder carcinoma (GBC).

         11. Patients who have not received systemic treatment for unresectable or metastatic
             biliary tract cancer or received only one systemic anti-tumor chemotherapy regimen;
             patients who have received one adjuvant or neoadjuvant chemotherapy regimen and
             relapsed more than 6 months after the end of chemotherapy can be enrolled.

        Exclusion Criteria:

          1. Positive HIV antibody.

          2. Active hepatitis, (hepatitis B: HBsAg positive with abnormal liver function and
             HBV(hepatitis B virus )-DNA ≥ 1000 IU/ml; hepatitis C: HCV(hepatitis C virus)-RNA
             positive with abnormal liver function).

          3. Treatment with corticosteroids > 20 mg/ day prednisone or other equivalent hormone
             (unless used to prevent contrast media reactions during radiological procedures),
             growth factors (eg, erythropoietin, granulocyte colony-stimulating factor, recombinant
             human thrombopoietin), blood transfusion.

          4. The toxic and side effects caused by the subject's previous treatment not recovered to
             CTCAE Grade ≤ 1, except for alopecia and other events judged to be tolerable by the
             investigator.

          5. Peripheral neuropathy of any grade within 28 days prior to the initiation of study
             drug.

          6. Patients with known sensitivity or hypersensitivity to platinum drugs and/ or
             gemcitabine.

          7. Having received a major surgery within 28 days prior to the initiation of study drug.

          8. Having received chemotherapy, biotherapy, radiotherapy, endocrine therapy and targeted
             anti-tumor therapy (except for nitrosoureas and mitomycin C) within 28 days prior to
             the initiation of study drug; received nitrosoureas or mitomycin C within 6 weeks
             prior to the initiation of study drug; received palliative local radiotherapy within 1
             week prior to the initiation of study drug; received Chinese herbal medicine with
             anti-tumor effect within 1 week before the initiation of the study drug.

          9. Patients with uncontrollable hypertension (normal range for diastolic blood pressure
             60-90 mmHg and for systolic blood pressure 90-140 mmHg ).

         10. Requiring systemic treatment for an acute bacterial, viral, or fungal infection, or
             having an unexplained fever (body temperature > 38.5℃) during screening prior to the
             first dose.

         11. Patients with moderate to large amount of body cavity effusion to be disposed of.

         12. With a known history of psychiatric disorders or drug abuse that may affect
             compliance.

         13. Presence of any of the following conditions within 6 months prior to signing informed
             consent: uncontrolled congestive heart failure (New York Heart Association class
             II-IV), angina pectoris, myocardial infarction, stroke (except for lacunar
             infarction), coronary/ peripheral artery bypass graft surgery, pulmonary embolism.

         14. Arrhythmia unable to be controlled by drugs or sustained QTc(corrected QT interval )
             interval prolongation, > 450 msec in males or > 470 msec in females.

         15. Having participated in other clinical studies within 28 days prior to the first dose
             of the study drug.

         16. Pregnant or lactating women.

         17. Women of childbearing potential, men of childbearing potential and their partners who
             are unable to use effective and adequate dual contraception while receiving the study
             drug and for 3 months after the end of the study.

         18. Patient not suitable for participating in the study for any reason judged by the
             investigator.

             Additional exclusion criteria applicable to phase II trial period:

         19. Patients with advanced biliary tract cancer previously treated with gemcitabine.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Tianshu Liu, M.D., 8621-23193802, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05357196

Organization ID

SCI-PT112-ONC-P2-002


Responsible Party

Sponsor

Study Sponsor

SciClone Pharmaceuticals


Study Sponsor

Tianshu Liu, M.D., Principal Investigator, Fudan University


Verification Date

April 2022