A clinical trial to study the effect of NRC-AN-019 in patients with various cancers.

A Phase-I Clinical Study to Evaluate the Safety, Pharmacokinetics and Anti-Tumor Activity of NRC-AN-019 in Patients with Solid Tumors.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000900

Enrollment

Registered

2009-11-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NRC-AN-019: 200 mg Capsules for 30 days Control Intervention1: Nil: Nil

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
To estimate the Dose Limiting Toxicity and Maximum Tolerated Dose of NRC-AN-019Timepoint: 30 days	—

Secondary

Measure	Time frame
To characterize the Pharmacokinetics and therapeutic efficacy of NRC-AN-019Timepoint: 30 days	—

Countries

India

Contacts

Public ContactDr G Venkat Ramana

Sponsor

pcmyneni@yahoo.com040-23547532

Outcome results