Phase-I Clinical Trial to study the Safety of oral drug Bioplatin in patients of Advanced metastatic Solid Tumours and those who are resistant to conventional treatments
- Conditions
- Health Condition 1: C00-D49- NeoplasmsHealth Condition 2: null- Patients with Solid Tumors refractory to conventional treatments and advanced metastatic tumors
- Registration Number
- CTRI/2017/06/008778
- Lead Sponsor
- Rasayani Biologics Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
1. Histologically-confirmed malignancy that is locally advanced, recurrent or metastatic for which standard curative measures do not exist or are no longer effective.
2. Disease that is measurable and/ or evaluable by RECIST criteria5. Patients with prostate cancer require presence of disease on bone scan and/or CT scan and evidence of increasing PSA after standard hormonal therapy
3. ECOG Performance6 Status <= 2
4. Life expectancy estimated to be at least 3 months
5.Acceptable liver function:
In the absence of disease involvement in the liver and if bilirubin <= 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and serum alkaline phosphatase may be <= 2.5 times ULN
In the presence of disease involvement in the liver and if bilirubin <= 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and serum alkaline phosphatase may be <= 5 times ULN
In the presence of bone metastasis, liver specific alkaline phosphatase may be separated from the total and used to assess liver function.
6. Acceptable renal function:
Serum creatinine <= 1.5 times ULN, OR
Calculated creatinine clearance >= 50 mL/min (Cockcroft-Gault formula)
7. Acceptable hematologic status:
Absolute neutrophil count (ANC) >= 1500 cells/mm3 (1.5 Ã?10e9/L)
Platelet count >= 100,000 platelet/mm3 (100 Ã?10e9/L)
Hemoglobin >= 9 g/dL
Urinalysis with no evidence of proteinuria
Acceptable coagulation profile (PT or INR, PTT) < 1.5 times ULN
8. Prior Medication: Should not have taken chemotherapy 4 weeks prior to start of clinical trials.
9.Patients must give written informed consent before study participation.
10.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
1. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
2. Patients participating in another clinical trial of an investigational agent or those who received treatment in another clinical trial within 30 days prior to commencing study treatment.
3. Patients with known advanced brain metastases & neurologically compromised are excluded from this clinical trial.
4. History of other malignancies except: (1) adequately treated basal cell or squamous cell
Carcinoma of the skin; (2) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, c) superficial bladder cancer;
5. Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
6. HIV-positive patients and known HBsAg or HCV positive patients.
7.Patients receiving any other anti-cancer treatment, aside from control of symptoms
8.Underwent major surgery within 28 days prior to commencing study treatment
9. History of bleeding diathesis or coagulopathy.
10. Refractory nausea or vomiting, malabsorption, dysphagia, significant bowel resection, or
any other medical condition that would preclude adequate absorption or result in inability to take oral medication.
11. Significant cardiovascular impairment (H/o congestive heart failure NYHA Grade > 2,
unstable angina or myocardial infarction within the past 6 months, or serious cardiac
arrhythmia)
12. Patients with organ allografts requiring immunosuppression.
13. Have any medical condition that would interfere with the conduct of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the maximum tolerated dose at the end of the sequential escalation of dose during the duration of the trialTimepoint: At the end of the trial
- Secondary Outcome Measures
Name Time Method â?¢Safety and tolerability check for clinical manifestations and through biochemical tests on the Serum at regular intervals. <br/ ><br>â?¢Objective Response rate at the end of 28 days and at End of Treatment as per RECIST 1.1. <br/ ><br>â?¢Platinum levels in blood and urine <br/ ><br>â?¢Evaluation of changes in Health-related Quality of life <br/ ><br>Timepoint: Safety studies at screening,day8,day21 ,Day 28,Day 56,Day 85,Day 113 and 4 weeks after End of Treatment. <br/ ><br>Quality of life will be evaluated at Day 1,Day28,Day56,Day 85,Day 113 and 4 weeks after EOT <br/ ><br>Tumour response will be evaluated at screening ,Day28 and day 113 . <br/ ><br>Platinum levels will be detected at Day 1 and Day 21. <br/ ><br>