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Sponsored by: |
Piramal Life Sciences Limited |
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Information provided by: | Piramal Life Sciences Limited |
ClinicalTrials.gov Identifier: | NCT00824343 |
This is a single arm phase II trial to study the efficacy and safety of a Cdk inhibitor P276-00 in the treatment of squamous cell carcinoma of head and neck. Patients with recurrent or metastatic disease that is unresectable and incurable by radiation will be enrolled. Patients with incurable and unresectable locally advanced disease that has been demonstrated to be refractory to at least one regimen of chemotherapy can also be enrolled. Thirty eight evaluable patients need to be enrolled in the study. Assuming drop-out rate of 30%, it is estimated that approximately 54 patients will be enrolled in the study. All patients will receive protocol treatment i.e. P276-00 as an intravenous infusion from day 1 to day 5 in each 21 days cycle till progression of disease or unacceptable toxicity. Safety evaluations by means of recording vitals, physical examination and lab investigations like hematology and clinical chemistry will be undertaken at regular intervals in each cycle. Tumor measurements by spiral CT scan will be undertaken at baseline and at the end of every 2 cycles for response evaluation by RECIST criteria. All patients will be followed up for survival status till one year of cycle 1 day 1.
Condition | Intervention | Phase |
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Squamous Cell Carcinoma of Head and Neck |
Drug: P276-00 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open Label, Multicenter Phase II Study to Evaluate Efficacy and Safety of P276-00 in Indian Subjects With Recurrent, Metastatic or Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck |
Estimated Enrollment: | 54 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single P276-00 arm: Experimental
This is a single experimental arm study
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Drug: P276-00
P276-00 will be administered to all subjects at a dose of 185 mg/m2/day as i.v infusion in 200 ml of 5% dextrose over 30 minutes from day 1 to day 5 in each 21 day cycle. Subjects will receive treatment till progression of disease or till unacceptable toxicity. All subjects will be followed up for survival status till one year of initiation of protocol treatment.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India, Karnataka | |
Bharath Hospital & Institute of Oncology, Mysore | Recruiting |
Mysore, Karnataka, India, 570017 | |
Contact: Dr. Geetha argeethanarendra@yahoo.com | |
Principal Investigator: Dr. M S Vishveshwara | |
India, Kerala | |
Regional Cancer Centre | Recruiting |
Trivandrum, Kerala, India, 695011 | |
Contact: Dr.Anju Gopan +914712442541 anjugopan2001@yahoo.com | |
Principal Investigator: Dr. Rejnish Kumar | |
India, Maharashtra | |
Central India Cancer Research Institute, | Recruiting |
Nagpur, Maharashtra, India, 440010 | |
Contact: Dr.Ajay Mehta 07122520956 / 2528514 ajayonco@hotmail.com | |
Principal Investigator: Dr. Ajay Mehta | |
Jaslok Hospital, Mumbai | Not yet recruiting |
Mumbai, Maharashtra, India, 400026 | |
Contact: Dr. Mehboob Basade basade@gmail.com | |
Principal Investigator: Dr. Mehboob Basade | |
Kashyap Nursing Home | Recruiting |
Mumbai, Maharashtra, India, 400014 | |
Contact: Dr. Nilesh Lokeshwar, MD, DM +912224110238 nileshlok@yahoo.com | |
Principal Investigator: Dr. Nilesh Lokeshwar, MD, DM | |
India, Rajasthan | |
Bhagwan Mahaveer Cancer Hospital & Research Centre, Dept. Of Medical Oncology, Jaipur | Recruiting |
Jaipur, Rajasthan, India, 302 017 | |
Contact: Dr. Anil Garg +911412700107 kumaranil_garg@yahoo.com | |
Principal Investigator: Dr. Lalit Mohan Sharma | |
India, UttarPradesh | |
Dept. Of Surgical Oncology, CSM Medical University, Lucknow | Recruiting |
Lucknow, UttarPradesh, India, 226003 | |
Contact: Dr. Sanjeev Misra misralko@gmail.com | |
Contact: Mr. Durgesh Agnihotri durgeshagnihotri@yahoo.com | |
Principal Investigator: Dr. Sanjeev Misra |
Principal Investigator: | Dr. Ajay Mehta | Director and Onco-Surgeon, Central India Cancer Research Institute, Nagpur |
Principal Investigator: | Dr. M S Vishveshwara | Radiation Oncologist, Bharat Hospital Institute of Oncology, Mysore |
Principal Investigator: | Dr. Sanjeev Misra | Oncosurgeon, Department of Surgical Oncology, CSM Medical University, Lucknow |
Principal Investigator: | Dr. Rejnish Kumar | Associate Professor, Regional Cancer Centre, Trivandram |
Principal Investigator: | Dr. Lalit Mohan Sharma | Consultant Medical Oncologist, Bhagwan Mahavir Cancer Hospital and Research Centre, Jaipur |
Principal Investigator: | Dr. Maheboob Basade | Medical Oncologist, Jaslok Hospital, Mumbai |
Principal Investigator: | Dr. Nilesh Lokeshwar, MD, DM | Medical Oncologist |
Responsible Party: | piramal Life Sciences Limited Mumbai ( Dr. Himanshu Parikh ) |
Study ID Numbers: | P276-00/21/08 |
Study First Received: | January 15, 2009 |
Last Updated: | April 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00824343 History of Changes |
Health Authority: | India: Drugs Controller General of India |
Head and Neck Neoplasms Epidermoid Carcinoma Neoplasms, Squamous Cell Squamous Cell Carcinoma |
Carcinoma, Squamous Cell Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Squamous Cell |
Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |