Trial Title:
A Study of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Lymphoma or Solid Tumor Patients
NCT ID:
NCT06521931
Condition:
Thrombocytopenia
Conditions: Official terms:
Thrombocytopenia
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PN20
Description:
Three dose cohorts: 0.2, 0.5 and 0.75 mg/kg, subcutaneous injections, on Day 1 of
chemotherapy cycle before the administration of chemotherapy drugs
Arm group label:
PN20 group
Summary:
The main aim of this clinical trial is to assess the safety and tolerability of PN20 in
adult patients with chemotherapy-induced thrombocytopenia (CID). The main questions it
aims to answer are:
- Is PN20 safe in these patients?
- Could these patients potentially benefit from PN20 prevention? Participants will
- Receive subcutaneous injections of PN20 according to weight on the first day of
chemotherapy cycle, within 1 hour before the administration of chemotherapy drugs,
- Visit the clinic on Day 1 (D1), D2, D3, D4, D5, D8, D11, D13, D15 and D21 for
assessment.
Detailed description:
This is a multicenter, single-arm, open-label, dose escalation study to evaluate the
safety, tolerability, pharmacokinetic, pharmacodynamics and immunogenicity of PN20 for
the Prevention of Chemotherapy-induced Thrombocytopenia in Adult Patients With Lymphoma
or Solid Tumor.
This study was divided into two phase, single-dose and multiple-dose. After single-dose
period (21 days), if the subject meets the multiple-dose criteria, he or she can enter
the multiple-dose phase for the second cycle of PN20 prevention. Subjects could receive a
maximum of two cycles of PN20 prevention.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged ≥ 18 years, regardless of gender;
2. Diagnosed with lymphoma or solid tumor by pathological histology or cytology
examination;
3. Currently receiving a 21-day chemotherapy regimen, using one or more of the
following or similar drugs: gemcitabine; platinums, including carboplatin,
nedaplatin, cisplatin, lobaplatin, etc.; anthracyclines, including doxorubicin,
daunorubicin, epirubicin, etc.; taxanes, including paclitaxel, docetaxel, etc.;
alkylating agents, including cyclophosphamide, ifosfamide, etc.;
4. The current chemotherapy regimen should be consistent with that of the previous
chemotherapy cycle before enrollment, including the type and dosage of the drugs,
and no medication or dosage adjustments are allowed;
5. Platelet count (PLT) was between 75 and 150×10^9/L (including the critical value)
one day before the start of chemotherapy in the first treatment cycle or before
enrollment;
6. There was a decrease in PLT to 25×10^9/L≤ PLT <75×10^9/L during the previous
chemotherapy cycle before enrollment;
7. Expected survival ≥ 12 weeks;
8. Eastern Cooperative Oncology Group (ECOG) Physical Score is ≤ 2;
9. No fertility plan during the trial and within 6 months after the end of the
follow-up, and agree to take medically recognized contraceptive measures (such as
complete abstinence, condoms, contraceptive rings, ligation, drug contraception,
etc.) to avoid pregnancy for themselves or their partners;
10. Be able to understand the requirements and procedures of the protocol, voluntarily
participate and sign the informed consent form.
Exclusion Criteria:
1. With thrombocytopenia caused by non-chemotherapy within 6 months before screening,
including but not limited to ethylenediaminetetraacetic acid (EDTA)-dependent
pseudothrombocytopenia, hypersplenism, infection and bleeding;
2. With other hematopoietic diseases other than lymphoma and chemotherapy induced
thrombocytopenia, including leukemia, primary immune thrombocytopenia,
myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome;
3. The tumor has already undergone bone marrow invasion or metastasis;
4. With active central nervous system metastasis (such as clinical symptoms, cerebral
edema, requiring hormone intervention (excluding maintenance of low-dose hormones)),
progression of brain metastasis, and carcinomatous meningitis. Subjects with
previously treated brain metastases who meet the following conditions may
participate in the study: clinical stability has been maintained for ≥ 2 months, and
systemic hormone therapy (prednisone or other equivalent doses of hormones at a dose
of >10 mg/day) has been discontinued for >4 weeks;
5. Acute or active bleeding of clinical significance (such as gastrointestinal or
central nervous system) within 7 days before screening;
6. Have a history of any arteriovenous thrombosis within 6 months before screening;
7. Have a history of major cardiovascular disease within 6 months before screening
(such as congestive heart failure (New York Heart Association (NYHA) heart function
score III-IV), arrhythmias known to increase the risk of thromboembolic events
(atrial fibrillation, etc.), coronary stent implantation, angioplasty or coronary
artery bypass grafting);
8. Accompanying diseases that the investigator believes the investigational drug may
cause unnecessary risks of, such as: severe cardiovascular and cerebrovascular
diseases, digestive system diseases, liver and kidney dysfunction diseases, or a
family history of mental illness;
9. Laboratory examination abnormalities during the screening period (baseline), such
as:
1. Blood biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase
(AST), total bilirubin ≥ 3 times the upper limit of normal (ULN) (if liver
metastasis exists, ALT, AST, total bilirubin can be ≥ 5 × ULN); serum
creatinine ≥ 1.5 × ULN;
2. Blood routine: absolute neutrophil value <1.5×10^9/L; hemoglobin < 80 g/L;
10. Abnormal electrocardiogram of clinical significance during screening or prolonged
QT/QTc interval, such as QTcF ≥ 450ms (male) or 470ms (female); family history of QT
prolongation;
11. Active hepatitis B (hepatitis B virus titer > 1,000 copies/ml or 200IU/ml);
hepatitis C virus infection (HCV-RNA Above the detection limit); preventive
antiviral treatment other than interferon is allowed. For patients with
hepatocellular carcinoma (HCC), hepatitis B virus titer> 10,000 copies/ml or
2000IU/ml; human immunodeficiency virus antibody (HIV), syphilis positive;
12. Received platelet transfusion within 5 days before the first dose;
13. Anticoagulants (heparin, warfarin, apixaban, bivalirudin, etc.), antiplatelet drugs
(clopidogrel, aspirin, etc.), fibrinolytic drugs (urokinase, etc.) were used for
prevention or treatment within 1 week before the first dose;
14. Received other drugs with platelet-raising effects (e.g., caffeic acid tablets,
leucogen tablets, aminopeptide tablets, or platelet-raising capsules, etc.) within 1
week before the first dose; received recombinant human thrombopoietin (rh-TPO) or
used recombinant human interleukin-11 (rhIL-11), thrombopoietin receptor agonist
(TPO-RA) within 10 days before the first dose or 5 half-lives of the drug (whichever
is longer);
15. Currently receiving or received radiotherapy within 3 months before screening;
16. Received bone marrow transplantation or stem cell infusion within 1 year before
screening;
17. Allergic to the investigational drug or excipients (such as histidine, glycine,
mannitol, sucrose) or previously experienced life-threatening systemic allergic
reaction;
18. Used other clinical trial drugs or devices within 4 weeks before the first dose;
19. Other conditions the investigator believes would be unsuitable for participation in
this clinical study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital of Hebei University
Address:
City:
Baoding
Zip:
071000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Yang
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
471003
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiye Zhang
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Suxia Luo
Facility:
Name:
Yiyang Central Hospital
Address:
City:
Yiyang
Zip:
413099
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Zhang
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Zip:
266057
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Cao
Facility:
Name:
Affiliated Hospital of Southwest Medical University
Address:
City:
Luzhou
Zip:
646000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoming Li
Start date:
December 6, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Chongqing Peg-Bio Biopharm Co., Ltd.
Agency class:
Industry
Source:
Chongqing Peg-Bio Biopharm Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06521931
