Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of Injectable PEG-Irinotecan (JK-1201I) in Patients with Malignant Solid Tumor
Lead Sponsor:
JenKem Technology Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this clinical trial is to evaluate the safety and tolerability of injectable PEG-Irinotecan in patients with malignant solid tumors
Detailed Description
This study is a multicenter, open labeled, positive controlled, single, -combined, with multiple dose escalation trial. The trial consists of 6 drug dose groups, which are 50mg/m2, 75mg/m2, 100mg/m2,...
Eligibility Criteria
Inclusion
- 18 to 70 years of age (inclusive)；
- Body mass index (BMI) within the range of 19-30 (inclusive)
- Patient with a malignant solid tumor that has been confirmed by histopathology and/or cytology to be ineffective in conventional treatment or lack effective treatment。 Primary tumors include colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer and advanced breast cancer patients with brain metastases
- More than 4 weeks after the completion of previous anti-tumor therapy (including chemotherapy/radiotherapy, surgical treatment, targeted therapy, immunotherapy, Chinese herbal medicine therapy, endocrine therapy or other anti-tumor therapy), And it has recovered from the adverse reactions of previous treatments (treatment-related toxicity grade ≤1);
- At least one measurable or evaluable lesion was identified using RECIST 1.1;
- Physical state score (ECOG PS score) 0\~1
- Estimated survival time ≥ 3 months
- Both standard blood tests and Blood Biochemistry tests are within normal range.
- All subjects and their partners have no plan to have children from screening to 6 month after the trial, and those who agree to use effective non-drug contraceptive methods during the trial period (e.g., condoms， etc.), those already have permanent contraceptive measures, such as bilateral tubal ligation, vasectomy, etc.
- Voluntarily participate in clinical research and sign informed consent
Exclusion
- Patients with previous allergy history and known severe allergy to injectable PEG-Irinotecan or any excipient of the product;
- Have received HCl-Irinotecan (CPY-11) treatment in the past
- With active brain metastasis;
- Have other malignant tumors within 5 years before enrollment, except for previously treated with the purpose of radical cure such as carcinoma in situ of the cervix, squamous cell carcinoma or basal cell carcinoma
- Large amount of thorax and ascites that need treatment
- Serious cardiovascular disease, including grade II and above cardiac dysfunction (NYHA standard)
- Active hepatitis b (HBsAg and/or HBCAb positive, peripheral blood HBV DNA titer test ≥1×103 IU/mL, or hepatitis c patients; or testing positive for syphilis or human immunodeficiency virus (HIV);
- Subject is participating in other clinical studies or the presumed first time of drug administration is less than 4 weeks from the end of the previous clinical study (last administration or 5 half-lives of the previous study drug);
- Subjects who have been treated with anti-tumor vaccines or other anti-tumor drugs (interferon, interleukin, etc.) with immune-stimulatory effects within 28 days before the assumed first medication
- Subjects who had a severe infection within 4 weeks before the first medication， including but not limited to complications of infection, bacteremia, severe pneumonia and others requiring hospital stays;
- Patient has electrolyte disorder with clinically significance
- Subject has clinically severe gastrointestinal disorders, (positive fecal occult blood with severe gastrointestinal bleeding, gastrointestinal infection, obstruction or diarrhea of grade 1 or above on endoscopic examination (the number of stool increases ≥4 times per day))
- Patients with bleeding tendency or receiving thrombolytic or anticoagulant therapy
- Within 14 days before receiving the study drug treatment subject have used a strong CYP3A4 inducer (Phenytoin or Carbamazepine, Barbiturates, Rifampicin or Rifabutin, Hypericum perforatum, etc.);
- Within 7 days prior drug treatment, patients have used strong CYP3A4 inhibitors (Clarithromycin, Ketoconazole or Itraconazole, Indinavir, Lopinavir, Nafazodone, Nelfinavir, Ritonavir, Saquinavir, Trapavir, Voriconazole, etc.)
- Within 7 days before receiving study drug treatment, subject has used strong UGT1A1 inhibitors (Atazanavir, Gemfibrozil, etc.)
- Clear history of neuropathy or mental disorders (including epilepsy or dementia)
- Persons with a history of alcohol or drug abuse
- Pregnant or lactating women
- Investigator considered the subject who are not suitable to participate in this study
Key Trial Info
Start Date :
May 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04366648
Start Date
May 4 2018
End Date
March 31 2021
Last Update
September 4 2024
Active Locations (1)
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1
The fifth medical center of PLA general hospital
Beijing, Beijing Municipality, China, 100071