A clinical trial to study the effect of NRC-AN-019 in patients with various cancers.
- Registration Number
- CTRI/2009/091/000900
- Lead Sponsor
- ATCO Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients must be greater than or equal 18 years old with expected life expectancy greater than 8 weeks.
2. Patients with disease not responding to currently available treatment options.
3. Patients must have recovered from the toxic effects of earlier radiotherapy or chemotherapy (if any)
4. Patients must have adequate bone marrow reserve
5. Patients must be willing to practice birth control during and for two months after treatment with study drug
6. Patients who are willing and able to give informed consent
7. Patients should have ECOG performance status less than or equal to 2.
1. Patients with major illness including active cardiac, hepatic, endocrine, renal or psychiatric disorders inadequately controlled with current therapy.
2. Concurrent use of other chemotherapeutic agents
3. Pregnancy or lactation or non-practice of birth control during and for 2 months after treatment with study drug
4. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, and which may obscure the evaluation of toxicity or alters drug metabolism.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the Dose Limiting Toxicity and Maximum Tolerated Dose of NRC-AN-019Timepoint: 30 days
- Secondary Outcome Measures
Name Time Method To characterize the Pharmacokinetics and therapeutic efficacy of NRC-AN-019Timepoint: 30 days