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

Phase 2

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

Registration Number: CTRI/2013/06/003768

Lead Sponsor: ATCO Pharma Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

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).

10. WBC at least 3,000/mm3, neutrophil count >=2000/mm3, platelet count >= 1,00,000.mm3 and hemoglobin level 8.0 g/dL

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Solid Tumors: <br/ ><br>1. PFS of at least 3 months for all tumors <br/ ><br>2. ORR as per RECIST criteria <br/ ><br>CML: <br/ ><br>1. Evaluation of MaHR and/or MCyRTimepoint: During Visit 2 to Visit 9

Secondary Outcome Measures

Name	Time	Method
1.All adverse events will be graded as per NCI-CTCAE criteria (version 4.0) <br/ ><br>2. Molecular response for CML patients <br/ ><br>Timepoint: During Visit 2 to Visit 9