NCT00824343

A Phase II Clinical Trial to Study the Efficacy and Safety of a New Drug P276-00 in Treatment of Recurrent and/or Locally Advanced Head and Neck Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Piramal Enterprises Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. Thirty eight evaluable patients need to 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 and from day 8 to day 12 in each 21 day 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.

Detailed description

P276-00 was administered at a dose of 185mg/m2/day from day 1 to day 5 in each 21 day cycle. The protocol was amended in July 2009. As per the amendment P276-00 will be administered at a dose of 144 mg/m2/day from day 1 to day 5 and from day 8 to day 12 in each 21 day cycle till progression of disease or unacceptable toxicity.33 patients have been recruited in version 1 protocol, 38 more evaluable patients need to be recruited in version 2 protocol. Allowing for approximately 30% drop-outs, it is estimated that, for enrolling 38 evaluable subjects in the study, approximately 54 subjects would be enrolled. As the study has already enrolled 33 subjects, the sample size for the study to accommodate for same number of subjects (38 evaluable) in the revised protocol is estimated as approximately 87 (33 + 54) subjects. Hence the total sample size (accounting for drop-outs) is 87 patients.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	P276-00	For patients to be recruited in amended protocol, P276-00 will be administered to all subjects at a dose of 144 mg/m2/day as i.v infusion in 200 ml of 5% dextrose over 30 minutes from day 1 to day 5 and from day 8 to day 12 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.

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-04-01
• Completion: 2013-06-01
• First posted: 2009-01-16
• Last updated: 2013-07-10

Locations

9 sites across 1 country: India