CTRI/2009/091/000900
Active, not recruiting
Phase 1
A Phase-I Clinical Study to Evaluate the Safety, Pharmacokinetics and Anti-Tumor Activity of NRC-AN-019 in Patients with Solid Tumors.
ATCO Pharma Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ATCO Pharma Ltd
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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