A Phase II Clinical Study to evaluate the efficacy and safety of NRC-AN-019 in cancer patients failing prior standard therapies

ATCO Pharma Limited0 sites0 target enrollmentTBD

ConditionsHealth Condition 1: null- 1. Patients with metastatic or locally advanced or inoperable solid tumors who have received prior treatment2. Chronic Myeloid Leukemia patients who are resistant and/or intolerant to Imatinib

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Health Condition 1: null- 1. Patients with metastatic or locally advanced or inoperable solid tumors who have received prior treatment2. Chronic Myeloid Leukemia patients who are resistant and/or intolerant to Imatinib
Sponsor: ATCO Pharma Limited
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Investigators

Sponsor

ATCO Pharma Limited

Eligibility Criteria

Inclusion Criteria

•1\. Histologically or cytologically confirmed metastatic or locally advanced or inoperable Pancreatic Cancer, Non\-Small Cell Lung Cancer (NSCLC), Breast Cancer, Glioma, Colorectal Cancer, Ovarian Cancer and Head \& Neck Cancer. Imatinib resistant and/or intolerant in case of GIST and CML
•2\. Male and female patients with age between 18 and 65 years
•3\. Must not have received chemotherapy or irradiation or any other investigational product within 14 days of entry to the trial
•4\. Eastern Cooperative Oncology Group (ECOG) performance status 0\-2
•5\. Patients must have measurable lesion, defined as that can be measured in at least one dimension (longer diameter)
•\>\=20 mm with conventional technique (CT/MRI) or as \>\= 10 mm with spiral CT
•6\. Patients with a probable minimum life expectancy \>\= 6 months
•7\. Must have adequate organ and marrow function
•8\. Renal function (normal serum creatinine and blood urea nitrogen)
•9\. Liver function (total bilirubin level \<\=2 times upper normal limit (UNL) and serum transaminases levels \<\= 2\.5 times UNL. \<\= 5 times for liver metastasis and/or obstructive jaundice).

Exclusion Criteria

•1\. The patient has not recovered from clinically\-meaningful toxicity due to prior therapy (i.e., back to baseline or Grade less than or equal to 1\), with the exception of neurotoxicity and alopecia
•2\. The patient has uncontrolled intercurrent illness including ongoing or active infection, diabetes mellitus, hypertension, symptomatic congestive cardiac failure, unstable angina pectoris, stroke or myocardial infarction within 3 months.
•3\. The patient is either pregnant or lactating
•4\. Patients who have tested positive to HIV or HBsAG or HCV
•5\. Patients with brain metastasis

Outcomes

Primary Outcomes

Not specified

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