Phase 1 clinical trial on Cancer patients
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]Health Condition 2: C920- Acute myeloblastic leukemiaHealth Condition 3: C7A0- Malignant carcinoid tumorsHealth Condition 4: C259- Malignant neoplasm of pancreas, unspecified
- Registration Number
- CTRI/2022/12/048015
- Lead Sponsor
- Vopec Pharmaceuticals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
Willing and able to provide voluntary informed consent and able to comply with protocol requirements.
2.Age – 20 to 65 years.
3.Patients with advanced Cancer not amenable to surgical therapy.
4.Patients must have measurable disease on radiological imaging of CT / MRI / PET scan to monitor treatment response. Measurable disease, as defined by RECIST v1.1.
5.Patients Undergoing is allowed to take part in the study.
6.Women of child bearing potential must agree to either use a contraceptive method or to remain abstinent during the treatment period and for at least 3 months after the last dose of study drug.
7.Life expectancy > 24 weeks.
8.Patient should be willing to undergo all treatment related procedures and investigations.
9.Patient should be willing and ready for PET scan, Blood Investigations, PK, ECG and followup.
10.Patient is willing to take and to tolerate cytotoxic drugs.
11.No history of addiction to any recreational drug or drug dependence.
12.Non-smokers and non-alcoholics.
1.Patients above 65 years of age.
2.Pregnant or lactating women, or intending to become pregnant during the study.
3.Life threatening comorbidities such as HIV, HPV, HBV, HCV, Tuberculosis, CHF, Impaired Hepatic or Renal Function or any psychological deficits etc.
4.Known CNS disease (Alzheimer’s disease, Parkinson’s disease, Bell’s palsy, Cerebral Palsy, Epilepsy, Motor Neuron disease (MND), Multiple Sclerosis (MS), Neurofibromatosis. Sciatica and Shingles) except for treated asymptomatic CNS metastases.
5.Uncontrolled pleural effusion, pericardial effusion, or as cites.
6.Uncontrolled tumor-related pain.
7.Significant cardiovascular disease, such as New York Heart Association of classification (NYHA) cardiac disease (Class II or greater), MI within 3 months prior to randomization, unstable arrhythmias, or unstable angina.
8.Major surgical procedure within 4 weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis.
9.History of autoimmune disease.
10.Prior allogeneic stem cell or solid organ transplantation.
11.Poor peripheral venous access.
12.Any other medical condition or uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.) that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
13.Patients not suitable for study as per investigators opinion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and toxicity profile of AB001 in patients with metastasis cancer using the NCI CTCAE V4.03, and determine the maximum tolerated dose (MTD). <br/ ><br>1.To determine the maximum tolerated dose (MTD) of AB001. <br/ ><br>2.To determine the dose limiting toxicities (DLT) of AB001. <br/ ><br>3.To establish a safe dose level of AB001 that can be used for future studies. <br/ ><br>Timepoint: Day 0 to Day 14
- Secondary Outcome Measures
Name Time Method 1.The pharmacokinetics of AB001 in humans. <br/ ><br>2.Observe for evidence of antitumor activity following administration of AB001. <br/ ><br>3.If AB001 induces changes in the biomarker in peripheral blood lymphocytes. <br/ ><br>4.If there is a pharmacodynamic relationship between the plasma / blood concentrations of AB001 and a clinical or cellular effect. <br/ ><br>5.To monitor the tumor reduction & adverse events and to ensure the safety of patients <br/ ><br>Timepoint: Day 0 to Day 14 <br/ ><br> <br/ ><br>Safety follow up evaluation : on 21st day