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

Phase 2

Active, not recruiting

• Conditions: 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: NATCO Pharma Limited

Brief Summary

Despite significant advances in systemic therapies, radiotherapy, and surgical techniques, cancer still remains incurable. One of the approaches that have been recently used widely is to target the receptor tyrosine kinases. These kinases are often over expressed and/or mutated in many tumors and thus regulate proliferation, apoptosis, angiogenesis, tumor invasiveness and distant metastases. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

 NRC-AN-019 is a small molecule tyrosine kinase inhibitor discovered and developed by NATCO Pharma Limited, a pharmaceutical company based in Hyderabad, INDIA. The drug has been patented by NATCO in several countries.

The  proposed Phase-II clinical trial entitled "A Phase II Clinical Study to evaluate the efficacy and safety of NRC-AN-019 in cancer patients failing standard prior therapies" will be conducted in the following indications:

1. Pancreatic Cancer

2. NonSmall Cell Lung Cancer

3. Breast Cancer

4. Glioma

5. Colorectal Cancer

6. Ovarian Cancer

7. Head and Neck Cancer

8. Gastro-intestinal stromal tumors (GIST)

9. Chronic Myeloid Leukemia (CML)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-08
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• 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.
• 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).
• 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

• 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.
• 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:	During Visit 2 to Visit 9
1. PFS of at least 3 months for all tumors	During Visit 2 to Visit 9
2. ORR as per RECIST criteria	During Visit 2 to Visit 9
CML:	During Visit 2 to Visit 9
1. Evaluation of MaHR and/or MCyR	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)	2. Molecular response for CML patients

Trial Locations

Locations (7)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Basavatarakam Indo American Cancer Hospital and Research Institute; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Nizam’s Institute of Medical Sciences; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Postgraduate Institute of Medical Education & Research; 🇮🇳 Chandigarh, CHANDIGARH, India

Saroj Gupta Cancer Center and Research Institute; 🇮🇳 Kolkata, WEST BENGAL, India

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

The Gujarat Cancer & Research Institute; 🇮🇳 Ahmadabad, GUJARAT, India

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Pravas Chandra Mishra

Principal investigator

01126594670

pravas_mishra@rediffmail.com