Biliary Tract CancerPhase 1/2NCT05357196
PT-112 (Phosplatin's Platinum) Combine With Gemcitabine Injection for Advanced Solid Tumors
A Phase 1/2 study testing PT-112 in people with Biliary Tract Cancer, run by SciClone Pharmaceuticals at 4 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- PT-112
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesChina
- Study dates
- 13 Apr 2020to 28 Apr 2023
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
- Additional inclusion criteria applicable to phase II trial period:
- 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.
Who cannot join
- 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.
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- 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.
- Pregnant or lactating women.
- 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.
- Patient not suitable for participating in the study for any reason judged by the investigator.
- Additional exclusion criteria applicable to phase II trial period:
- Patients with advanced biliary tract cancer previously treated with gemcitabine.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
The First Affiliated Hospital ZheJiang University School Of Medicine
Hangzhou, Zhejiang, 310003
Haiping Jiang, M.D., 15257126683, Jianghaiping75@163.com
- Not yet recruiting
General Hospital Of Eastern Theater Command
Nanjing, Jiangsu, 210002
Shukui Qin, M.D., 8625-84453932, qinsk81@163.com
- Recruiting
Zhongshan Hospital Fudan Universtity
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, M.D., 13681973996, liu.tianshu@zs-hospital.sh.cn
- Recruiting
ZhongNan Hospital Of Wuhan University
Wuhan, Hubei, 430071
Fuxiang Zhou, M.D., 18971252780, 592071015@qq.com
About this study
Official title: An Open-label Phase I/II Clinical Trial of PT-112 Combine With Gemcitabine Injection for Advanced Solid Tumors
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
Read the 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).
- Conditions
- Biliary Tract Cancer
- Being tested
- PT-112
- Keywords
- PT-112
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT-112Drug
Also called Gemcitabine
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.
| Study group | Role | What they receive |
|---|---|---|
| PT-112 in Combination with Gemcitabine Injection | Other | PT-112 in combination with Gemcitabine injection for the treatment of patients with advanced solid tumors Receives: Drug: PT-112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 24 months
Secondary outcomes (4)
Anti-tumor efficacy evaluation (Phase I)
Disease Control Rate by disease manifestation, evaluated using RECIST 1.1 criteria.
Measured: 30 months
Peak Plasma Concentration (Cmax) (Phase I)
To assess the Peak Plasma Concentration (Cmax) profile of 21 subjects who have used PT-112 in combination with Gemcitabine. PT-112 and Gemcitabine related PK parameters.
Measured: 30 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Phase II)
To obtain the Adverse Events (AEs) of all 47 subjects with advanced biliary tract cancer and have used PT-112 Injection in combination with Gemcitabine Injection for treating . Characterization of the type, incidence, severity, duration, reversibility and relationship to treatment of adverse events (AEs), and effects on vital signs and laboratory parameters.
Measured: 24 months
Area under the plasma concentration versus time curve (AUC)
To assess the Area under the plasma concentration versus time curve (AUC) profile of 21 subjects who have used PT-112 in combination with Gemcitabine.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start13 Apr 2020
- Primary completion30 Aug 2022 (estimated)
- Study completion28 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SciClone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tianshu Liu, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357196
- Sponsor's protocol ID
- SCI-PT112-ONC-P2-002
- Status last verified
- Apr 2022
- First submitted
- 13 Jan 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase I/II Clinical Trial of PT-112 Combine With Gemcitabine Injection for Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05357196
- Acronym / sponsor ID
- SCI-PT112-ONC-P2-002
- Conditions
- Biliary Tract Cancer
- Keywords
- PT-112
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- SciClone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 28 Apr 2023 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| PT-112 in Combination with Gemcitabine Injection | Other | Drug: PT-112PT-112 in combination with Gemcitabine injection for the treatment of patients with advanced solid tumors |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PT-112Also: GemcitabineDrug: 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. | Drug | PT-112 in Combination with Gemcitabine Injection |
Primary outcome
Define the recommended dose level for PT-112(Phase I)
Time frame: 30 months
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.
To obtain best disease control rate (DCR) data(Phase II)
Time frame: 24 months
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)
4 secondary outcomes
Anti-tumor efficacy evaluation (Phase I)
Time frame: 30 months
Peak Plasma Concentration (Cmax) (Phase I)
Time frame: 30 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Phase II)
Time frame: 24 months
Area under the plasma concentration versus time curve (AUC)
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
Related trials for Biliary Tract Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tianshu Liu, M.D. principal investigator
Fudan University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PT-112 in people with Biliary Tract Cancer, run by SciClone Pharmaceuticals at 4 sites in China.
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 15 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: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoning guo, M.D. (8621-23193802 ext. 8621-23193801, guoxiaoning@sciclone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the recommended dose level for PT-112(Phase I) (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2022.