A Clinical Study to know the safety, pharmacokinetics and anticancer activity of NRC-2694-A in patients with advanced cancers

Phase 1

Completed

• Conditions: Health Condition 1: null- Advanced Solid MalignanciesHealth Condition 2: D499- Neoplasm of unspecified behavior of unspecified site

• Registration Number: CTRI/2014/01/004293
• Lead Sponsor: ATCO Pharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-02-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

•Patients must be greater or equal to 18 years old with expected life expectancy more than 8 weeks.

•ECOG Performance Score less than or equal to 2

•Patients with evaluable disease, histologically documented confirmed diagnosis of an advanced solid malignancy for whom standard treatment options did not exist

•Adequate bone marrow reserve (WBC at least 3,000/mm3, neutrophil count greater than or equal to 2000/mm3, platelet count greater than or equal to 1,00,000mm3 and hemoglobin level 8.0 g/dL), renal function (normal serum creatinine), liver function [total bilirubin level less than or equal to 2 times upper normal limit (UNL) and serum transaminases levels less than or equal to 2.5 times UNL/ less than or equal to 5 times for liver metastasis and/or obstructive jaundice. Subjects must have tested negative for, HIV, HbsAg and pregnancy (for female subjects)

•Patients must not have received chemotherapy within 14 days (6 weeks for nitrosureas or mytomycin C) and radiotherapy within 3 weeks and must not have undergone surgery within 2 weeks before dosing

•Patients must be willing to practice birth control during and for 2 months after treatment

Exclusion Criteria

• Patients with major illness including active cardiac, hepatic, endocrine, renal or psychiatric disorders inadequately controlled with current therapy.

• Patients with brain metastases or primary CNS malignancies.

• Concurrent therapy for the cancer (Radiation therapy, chemotherapy etc)

• Patients who are pregnant or lactating.

• 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

• Impairment of gastrointestinal function that could significantly alter the absorption of the study drug and also the use of medication altering gastric pH (mild antacids are permitted if taken either 4 hours before or after the study drug administration)

Study & Design

• Study Type: Interventional
• Study Design: Not specified