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

NCT05357196 | Unknown Phase 1 DMC

• 1 other identifier: SCI-PT112-ONC-P2-002
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 4

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

Conditions

Biliary Tract Cancer

Keywords

PT-112

Outcome Measures

Primary Outcomes (2)

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

  Define the recommended dose level for PT-112, administered on Days 1 and 8 of each 21-day cycle, for pivotal studies based on the risk/benefit ratio of 150 mg/m2 、200 mg/m2 and 250 mg/m2 dose levels.

  30 months

• To obtain best disease control rate (DCR) data(Phase II)

  To obtain best disease control rate (DCR) data of 47 subjects who have used PT-112 Injection in combination with Gemcitabine Injection at RP2D(Recommended Phase II Dose ) dose for treating advanced biliary tract cancer. Endpoints: Disease control rate (DCR)

  24 months

Secondary Outcomes (4)

• Anti-tumor efficacy evaluation (Phase I)

  30 months

• Peak Plasma Concentration (Cmax) (Phase I)

  30 months

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Phase II)

  24 months

• Area under the plasma concentration versus time curve (AUC)

  30 months

Study Arms (1)

PT-112 in Combination with Gemcitabine Injection

OTHER

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

Drug: PT-112

Interventions

PT-112 DRUG

Drug: PT-112, The MTD(Maximum Tolerated Dose ) and RP2D of PT-112 when used in combination with gemcitabine will be determined during dose escalation. Drug: Gemcitabine, Gemcitabine will be administered at a fixed dose of 1000 mg.

Also known as: Gemcitabine

PT-112 in Combination with Gemcitabine Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-75 years (18 and 75 years included).
• 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.
• ECOG(Eastern Cooperative Oncology Group) performance status score of 0-1.
• Expected survival time greater than 12 weeks.
• 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.
• Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%.
• 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.
• 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).
• Subjects must give informed consent for the study prior to the test and sign the informed consent form.
• Patients with histologically or cytologically confirmed unresectable or metastatic biliary tract cancer, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), and gallbladder carcinoma (GBC).
• 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.

You may not qualify if:

• Positive HIV antibody.
• 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).
• 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.
• 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.
• Peripheral neuropathy of any grade within 28 days prior to the initiation of study drug.
• Patients with known sensitivity or hypersensitivity to platinum drugs and/ or gemcitabine.
• Having received a major surgery within 28 days prior to the initiation of study drug.
• 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.
• Patients with uncontrollable hypertension (normal range for diastolic blood pressure 60-90 mmHg and for systolic blood pressure 90-140 mmHg ).
• 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.
• Patients with moderate to large amount of body cavity effusion to be disposed of.
• With a known history of psychiatric disorders or drug abuse that may affect compliance.
• 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.
• Arrhythmia unable to be controlled by drugs or sustained QTc(corrected QT interval ) interval prolongation, \> 450 msec in males or \> 470 msec in females.
• Having participated in other clinical studies within 28 days prior to the first dose of the study drug.

Sponsors & Collaborators

• SciClone Pharmaceuticals: lead

Study Sites (4)

ZhongNan Hospital Of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

General Hospital Of Eastern Theater Command

Nanjing, Jiangsu, 210002, China

NOT YET RECRUITING

Zhongshan Hospital Fudan Universtity

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

The First Affiliated Hospital ZheJiang University School Of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Tianshu Liu, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoning guo, M.D.

CONTACT

8621-23193802; guoxiaoning@sciclone.com

Yongting Li, Master

CONTACT

8621-23193800; liyongting@sciclone.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One-armed test，An Open-Label Phase I/ II Clinical Study of PT-112 in Combination with Gemcitabine Injection for the Treatment of Patients with Advanced Solid Tumors

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: May 2, 2022
• Study Start: April 13, 2020
• Primary Completion: August 30, 2022
• Study Completion: April 28, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)