Advanced Solid TumorsPhase 1/2NCT03439761
An Open-label Phase I/II Clinical Trial of PT-112 Injection for Advanced Solid Tumors and Advanced Hepatocellular Carcinoma
A Phase 1/2 study testing PT-112 Injection in people with Advanced Solid Tumors, run by SciClone Pharmaceuticals at 1 site in China.
Trial summary
Use PT-112 alone for Phase I dose escalation stage: advanced solid tumors, Phase I dose confirmation stage: advanced solid tumors. Phase II hepatocellular carcinoma (HCC). To evaluate the safety and tolerability of PT-112 injection from 250mg/m2 dose level with 3+3 dose escalation design, find Maximum tolerated dose… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- PT-112 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2018to Jul 2020
- 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
- Age ≥ 18 years old and ≤ 75 years old, male or female
- Local advanced or metastatic solid tumors confirmed by histopathology or cytology that do not respond to standard treatment or have no standard effective treatment (including but not limited to hepatocellular carcinoma, gastric cancer, colorectal cancer, non-small cell lung cancer, head and neck cancer, and breast cancer)
- Compliance with the requirements for type of tumor in the group in dose confirmation stage;
- Eastern Cooperative Oncology Group (ECOG) physical score: 0 or 1
- Lesions that can be assessed by imaging according to the Response evaluation criteria in solid tumors (RECIST) 1.1 (not required in dose escalation stage);
- Expected survival>12 weeks;
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- Subjects should have appropriate organ function and should meet the following requirements for laboratory test results before inclusion:
- Generally normal bone marrow reserve: absolute neutrophil count (ANC)
- ≥1.510^9/L, platelet count≥10010^9/L and hemoglobin≥90 g/L; Generally normal liver function: serum albumin ≥3.0 g/dL; bilirubin ≤1.5×upper limits of normal (ULN), Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5×ULN, ALT or AST ≤5×ULN for patients with liver metastases or primary liver cancer; Normal renal function: creatinine ≤1.5×ULN or creatinine clearance ≥60ml/min (according to Cockcroft-Gault formula); Generally normal coagulation function: International Normalized Ratio(INR)≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN; Cardiac function: Left ventricular ejection fraction (LVEF)≥ 50%;
- Women of childbearing age (defined as women under 50 years old or above 50 years old who have an amenorrhea period shorter than 12 months before inclusion in the study) who show negative in serum β-human chorionic gonadotrophin (β-HCG) test;
- Subjects with history of brain metastases who are diagnosed with stable disease not requiring treatment with steroid or anticonvulsant, regardless of previous radiotherapy;
- Signing of informed consent form before participation in the study.
- Other inclusion criteria for the phase II trial:
- Advanced HCC diagnosed by histopathology or cytology that cannot be surgically removed or progresses after intervention/local treatment, previous treatment with one systemic anti-cancer chemotherapy, Barcelona Clinic Liver Cancer (BCLC) staging: Stage C, Child-Pugh A and mild grade B (≤7);
- Lesions that can be assessed by imaging according to the RECIST 1.1;
Who cannot join
- Untreated active hepatitis (hepatitis B: HBsAg positive with abnormal liver function and hepatitis B virus(HBV)-DNA ≥ 2000international unit (IU)/ml; hepatitis C: hepatitis C virus (HCV)-RNA positive and abnormal liver function);
- antitumor immunoregulation therapy, immunosuppressive therapy, corticosteroids > 20 mg/day (unless used to prevent contrast agent reactions during radiotherapy), growth factor therapy (such as erythropoietin) or transfusion therapy within 14 days before use of the investigational drug;
- Unrecovered toxic and side effects caused by previous treatment (CTCAE ≤ grade 1), except hair loss and other tolerable events judged by the investigators;
- Any grade of peripheral neuropathy within 28 days prior to use of the investigational drug;
- Known allergy or hypersensitivity to platinum drugs;
- Antitumor therapy like chemotherapy, biotherapy, radiotherapy, endocrine therapy, target therapy (except Nitrourea, mitomycin C) within 4 weeks before use of the investigational drug. Use Nitrourea or mitomycin C within 6 weeks before use of the investigational drug.
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- Major surgery within 28 days before use of the investigational drug;
- Acute bacterial, viral or fungal infections requiring systemic treatment or unexplained fever during screening before the first administration of drug (body temperature> 38.5℃);
- Moderate or massive effusion of body cavity need treatment;
- History of mental illness;
- Human Immunodeficiency Virus(HIV) carriers or Acquired Immune Deficiency Syndrome (AIDS) patients;
- Any of the following conditions within six months before sign informed consent form : uncontrolled congestive heart failure (New York Heart Association grade 2 or 4), angina pectoris, myocardial infarction, stroke (except lacunar infarction), coronary/peripheral artery bypass surgery, pulmonary embolism);
- Uncontrolled arrhythmia or persistent QT interval prolongation, > 450 ms for men or > 470 ms for women;
- Use of any investigational drug or device within 28 days before the use of investigational drug;
- Pregnant or lactating women;
- Women of childbearing age and fertile men who cannot take effective adequate double contraceptives during the study or within three months after completion of the study;
- Any other conditions based on which the investigators believe that the patient should not participate in the study;
- Other exclusion criteria for the phase II trial:
- Patients with advanced HCC who have received more than two kinds of systemic chemotherapy (but not including targeted therapies or immunity checkpoint inhibitors like programmed death(PD)-1 or PD-L1 antibody treatment).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Jin Li, MD, 021-38804518, tianyoulijin@163.com
About this study
Official title: An Open-label Phase I/II Clinical Trial of PT-112 Injection Alone in the Treatment of Patients With Advanced Solid Tumors and Advanced Hepatocellular Carcinoma
Use PT-112 alone for Phase I dose escalation stage: advanced solid tumors, Phase I dose confirmation stage: advanced solid tumors. Phase II hepatocellular carcinoma (HCC). To evaluate the safety and tolerability of PT-112 injection from 250mg/m2 dose level with 3+3 dose escalation design, find Maximum tolerated dose (MTD), Recommended Phase II Dose(RP2D) and evaluate the Pharmacokinetic (PK) profile of PT-112 through Phase I dose escalation stage. Phase I dose confirmation stage: evaluate the safety and tolerability of PT-112 with RP2D, evaluate the anti-tumor effect of PT-112 at RP2D. Phase II stage: evaluate the anti-tumor effect of PT-112 at RP2D in advanced HCC
Read the detailed description
This is a multicenter, open-label, phase I/II clinical trial that includes the dose escalation stage, dose confirmation stage and phase II stage.
In dose escalation stage, a 3+3 trial design is adopted for dose escalation. Three dose groups are designed: 200, 250 and 300 mg/m2, once weekly; 28 days constitute a period. The drug is intravenously dripped for 60 minutes at the 1st, 8th and 15th day of each period. The safety, tolerability, PK and preliminary antitumor effect of PT-112 injection alone are evaluated. After Dose limited toxicity (DLT) evaluation is completed for all the patients in a dose group, the Safety Monitoring Committee (SMC) will evaluate the safety and PK of the dose group based on the resulting data, and decide whether the dose should be escalated, and whether the dosing regimen or PK sampling points should be adjusted.
After dose escalation is completed, the RP2D is selected by SMC for dose confirmation. Dose confirmation study will include approximately 10 patients each of the following six types of tumors:
Group 1: Hepatocellular carcinoma Group 2: Gastric cancer Group 3: Colorectal cancer Group 4: Non-small cell lung cancer Group 5: Head and neck cancer Group 6: Breast cancer If it is difficult to include the patients with a specific type of tumor, or if the tumor is not sensitive to the efficacy of investigational drug, the SMC may discuss and decide to prematurely terminate inclusion of patients in that group.
After sufficient data are obtained in dose confirmation stage, the SMC may discuss and decide to initiate phase II trial. Phase II trial plans to include about 40 subjects to evaluate the anti-tumor effect and safety of the monotherapy in patients with advanced HCC who have previously received only one systemic anticancer therapy.
- Conditions
- Advanced Solid Tumors
- Being tested
- PT-112 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT-112 InjectionDrug
PT-112 Injection 28 days constitute a period. The drug is intravenously dripped for 60 minutes at the 1st, 8th and 15th day of each period.
| Study group | Role | What they receive |
|---|---|---|
| PT-112 Injection | Experimental | PT-112 Injection alone Receives: Drug: PT-112 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE)
The primary outcome for Phase I dose escalation stage
Measured: Informed consent form (ICF) signed till 28days after end of treatment
Dose Limited Toxicity (DLT)
The primary outcome for Phase I dose escalation stage
Measured: First dose till 28days after 1st dosing. (1st cycle treatment)
AE
The primary outcome for Phase I dose confirmation stage
Measured: ICF signed till 28days after end of treatment
Disease Control Rate (DCR)
The primary outcome for Phase II (rate of complete response(CR)+partial response (PR)+stable disease(SD))
Measured: subject enrolled till disease progress estimate 6 months after first dosing.
Secondary outcomes (7)
DCR
The secondary outcome for Phase I (rate of CR+PR+SD)
Measured: subject enrolled till disease progress estimate 6 months after first dosing.
Objective Response Rate (ORR)
The secondary outcome for Phase I/II (rate of CR+PR)
Measured: subject enrolled till disease progress estimate 6 months after first dosing.
Progress Free Survival(PFS)
The secondary outcome for Phase I/II
Measured: enrolled study till first disease progress estimate 6 months after first dosing.
Peak Plasma Concentration （Cmax）
The secondary outcome for Phase I dose escalation stage including: Cmax for PT-112.
Measured: collect PK blood sample in first and second cycles (28 and 56 days after 1st dosing)
Area under the plasma concentration versus time curve (AUC)
The secondary outcome for Phase I dose escalation stage including: AUC for PT-112.
Measured: collect PK blood sample in first and second cycles (28 and 56 days after 1st dosing)
Peak time （Tmax）
The secondary outcome for Phase I dose escalation stage including: Tmax for PT-112
Measured: collect PK blood sample in first and second cycles (28 and 56 days after 1st dosing)
AE
The secondary outcome for Phase II
Measured: AE from ICF signed till 28days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start7 Mar 2018
- Primary completionMay 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- PT-112 injection alone-chemotherapy
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SciClone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, MD, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439761
- Sponsor's protocol ID
- SCI-PT112-ONC-P1-002
- Status last verified
- Mar 2018
- First submitted
- 2 Feb 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. 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 Injection Alone in the Treatment of Patients With Advanced Solid Tumors and Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03439761
- Acronym / sponsor ID
- SCI-PT112-ONC-P1-002
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- SciClone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 20 Feb 2018 (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.
Use PT-112 alone for Phase I dose escalation stage: advanced solid tumors, Phase I dose confirmation stage: advanced solid tumors. Phase II hepatocellular carcinoma (HCC). To evaluate the safety and tolerability of PT-112 injection from 250mg/m2 dose level with 3+3 dose escalation design, find Maximum tolerated dose (MTD), Recommended Phase II Dose(RP2D) and evaluate the Pharmacokinetic (PK) profile of PT-112 through Phase I dose escalation stage. Phase I dose confirmation stage: evaluate the safety and tolerability of PT-112 with RP2D, evaluate the anti-tumor effect of PT-112 at RP2D. Phase II stage: evaluate the anti-tumor effect of PT-112 at RP2D in advanced HCC
Detailed description
This is a multicenter, open-label, phase I/II clinical trial that includes the dose escalation stage, dose confirmation stage and phase II stage.
In dose escalation stage, a 3+3 trial design is adopted for dose escalation. Three dose groups are designed: 200, 250 and 300 mg/m2, once weekly; 28 days constitute a period. The drug is intravenously dripped for 60 minutes at the 1st, 8th and 15th day of each period. The safety, tolerability, PK and preliminary antitumor effect of PT-112 injection alone are evaluated. After Dose limited toxicity (DLT) evaluation is completed for all the patients in a dose group, the Safety Monitoring Committee (SMC) will evaluate the safety and PK of the dose group based on the resulting data, and decide whether the dose should be escalated, and whether the dosing regimen or PK sampling points should be adjusted.
After dose escalation is completed, the RP2D is selected by SMC for dose confirmation. Dose confirmation study will include approximately 10 patients each of the following six types of tumors:
Group 1: Hepatocellular carcinoma Group 2: Gastric cancer Group 3: Colorectal cancer Group 4: Non-small cell lung cancer Group 5: Head and neck cancer Group 6: Breast cancer If it is difficult to include the patients with a specific type of tumor, or if the tumor is not sensitive to the efficacy of investigational drug, the SMC may discuss and decide to prematurely terminate inclusion of patients in that group.
After sufficient data are obtained in dose confirmation stage, the SMC may discuss and decide to initiate phase II trial. Phase II trial plans to include about 40 subjects to evaluate the anti-tumor effect and safety of the monotherapy in patients with advanced HCC who have previously received only one systemic anticancer therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PT-112 injection alone-chemotherapy
| Arm | Type | Receives |
|---|---|---|
| PT-112 Injection | Experimental | Drug: PT-112 InjectionPT-112 Injection alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years old and ≤ 75 years old, male or female
- Local advanced or metastatic solid tumors confirmed by histopathology or cytology that do not respond to standard treatment or have no standard effective treatment (including but not limited to hepatocellular carcinoma, gastric cancer, colorectal cancer, non-small cell lung cancer, head and neck cancer, and breast cancer)
- Compliance with the requirements for type of tumor in the group in dose confirmation stage;
- Eastern Cooperative Oncology Group (ECOG) physical score: 0 or 1
- Lesions that can be assessed by imaging according to the Response evaluation criteria in solid tumors (RECIST) 1.1 (not required in dose escalation stage);
Key exclusion criteria (19 listed)
- Untreated active hepatitis (hepatitis B: HBsAg positive with abnormal liver function and hepatitis B virus(HBV)-DNA ≥ 2000international unit (IU)/ml; hepatitis C: hepatitis C virus (HCV)-RNA positive and abnormal liver function);
- antitumor immunoregulation therapy, immunosuppressive therapy, corticosteroids > 20 mg/day (unless used to prevent contrast agent reactions during radiotherapy), growth factor therapy (such as erythropoietin) or transfusion therapy within 14 days before use of the investigational drug;
- Unrecovered toxic and side effects caused by previous treatment (CTCAE ≤ grade 1), except hair loss and other tolerable events judged by the investigators;
- Any grade of peripheral neuropathy within 28 days prior to use of the investigational drug;
- Known allergy or hypersensitivity to platinum drugs;
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-112 InjectionPT-112 Injection 28 days constitute a period. The drug is intravenously dripped for 60 minutes at the 1st, 8th and 15th day of each period. | Drug | PT-112 Injection |
Primary outcome
Adverse Event (AE)
Time frame: Informed consent form (ICF) signed till 28days after end of treatment
The primary outcome for Phase I dose escalation stage
Dose Limited Toxicity (DLT)
Time frame: First dose till 28days after 1st dosing. (1st cycle treatment)
The primary outcome for Phase I dose escalation stage
AE
Time frame: ICF signed till 28days after end of treatment
The primary outcome for Phase I dose confirmation stage
Disease Control Rate (DCR)
Time frame: subject enrolled till disease progress estimate 6 months after first dosing.
The primary outcome for Phase II (rate of complete response(CR)+partial response (PR)+stable disease(SD))
7 secondary outcomes
DCR
Time frame: subject enrolled till disease progress estimate 6 months after first dosing.
Objective Response Rate (ORR)
Time frame: subject enrolled till disease progress estimate 6 months after first dosing.
Progress Free Survival(PFS)
Time frame: enrolled study till first disease progress estimate 6 months after first dosing.
Peak Plasma Concentration （Cmax）
Time frame: collect PK blood sample in first and second cycles (28 and 56 days after 1st dosing)
Area under the plasma concentration versus time curve (AUC)
Time frame: collect PK blood sample in first and second cycles (28 and 56 days after 1st dosing)
Peak time （Tmax）
Time frame: collect PK blood sample in first and second cycles (28 and 56 days after 1st dosing)
AE
Time frame: AE from ICF signed till 28days after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: Yes
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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.
Jin Li, MD principal investigator
Shanghai East Hospital
1 site 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 Injection in people with Advanced Solid Tumors, run by SciClone Pharmaceuticals at 1 site 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 19 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 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Crystal Qin, MD, PhD (86-021-23193802, cqin@sciclone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (AE) (time frame: Informed consent form (ICF) signed till 28days after end of treatment). The study lists 4 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 16 Mar 2018.