iposomal Docetaxel injection in subjects with advanced solid tumors.
- Conditions
- Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
- Registration Number
- CTRI/2021/02/031437
- Lead Sponsor
- Shilpa Medicare LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Willing and able to give written and dated informed consent (or legally acceptable representative or impartial witness when applicable) and is available for the entire study.
2. Age 18 years or older and having Body mass index (BMI) greater or equal to 17.00 calculated as weight in kg per height in meter square.
3. Male or female subjects with a histologically confirmed locally advanced or metastatic solid tumor for whom no standard alternative therapy is available.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Life expectancy of greater than 90 days at the time of enrollment.
6. Acceptable hematology status:
a. Hemoglobin greater or equal to 9.0 g per dL
b. Absolute neutrophil count (ANC) greater or equal to 1500 cells per µL
c. Platelet count greater or equal to 1,00,000 cells per µL
d. Prothrombin time less than 1.5 Ã? ULN
7. Acceptable liver function:
a. Alanine aminotransferase (ALT) less than or equal to 1.5 X ULN
b. Aspartate aminotransferase (AST) less than or equal to 1.5 X ULN
c. Bilirubin less than 1.2 mg per dL
d. Alkaline phosphatase less than or equal to 2.5 X ULN
8. Subjects with Creatinine clearance greater or equal to 60 mL per minute
9. Subjects with negative serum pregnancy test at screening and negative urine pregnancy test at Day -1.
10. Subjects with negative alcohol breath test and urine drug of abuse test at Day -1.
11. Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing two acceptable methods of contraception.
Acceptable methods of contraception are:
a. Intrauterine device (IUD) or intrauterine system
b. Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
c. Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that subject)
d. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
e. Total abstinence, partial abstinence is not acceptable.
12. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
1. Known hypersensitivity or contraindication including anaphylaxis to docetaxel or to any of their components.
2. Known or symptomatic brain metastasis (other than totally resected or previously irradiated and non-progressive/relapsing) or lepto-meningeal carcinomatosis who are not clinically stable, are terminally ill and/or in the opinion of the investigator may not be able to comply with the study requirements
3. Subjects who are at risks of tumor lysis syndrome (e.g., with renal impairment, hyperuricemia, bulky tumor).
4. Concurrent treatment with any other anticancer therapy.
5. Pregnant or lactating women.
6. History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
7. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganism if under treatment with myelotoxic drugs.
8. Major surgical procedure (including periodontal) within 28 days of Investigational Product administration.
9. Surgical or other non-healing wounds.
10. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
11. History of other malignancies in the last 5 years. (except in situ cancer or basal or squamous cell skin cancer)
12. Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), Hemoglobin greater or equal to 9.0 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0).
13. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness or social situations that would limit adherence to study requirements.
14. Participation in any clinical study within 90 days before the administration of Investigational Product.
15. Donation and/or loss of greater or equal to 350 ml (1 unit) of blood within 90 days before administration of Investigational Product.
16. Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (a) Incidence of IP-related DLTs; (b) Recommended dose for phase 3 studyTimepoint: At the end of each cohort
- Secondary Outcome Measures
Name Time Method (a) Overall safety profile characterized in terms of the type, frequency, severity, seriousness, and relationship to study therapy of any AEs or abnormalities of physical findings, laboratory tests or other investigations; (b) To characterize PK profile; (c) To determine the dose proportionality after single dose intravenous administration of Liposomal Docetaxel injectionTimepoint: 00.00, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 120.00, 168.00, 336.00 and 504.00 hours.