Status:
COMPLETED
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
Lead Sponsor:
Piramal Enterprises Limited
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 dise...
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 m...
Eligibility Criteria
Inclusion
- Age more than or equal to 18 years
- Subjects with histologically or cytologically confirmed SCCHN that is recurrent and/or metastatic and judged incurable by surgery and/or radiation therapy and with zero to one line of chemotherapy for recurrent or metastatic disease at least 60 days prior to study entry.
- Measurable disease, defined as at least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥10 mm by spiral computerized tomography (CT) scan or magnetic resonance imaging (MRI)
- Tumor that is accessible to biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Life expectancy of at least three months
- Hemoglobin ≥ 8.0 gm/dL
- Absolute neutrophil count (ANC) ≥ 1000/mm3
- Platelet count ≥ 50,000/mm3
- Total bilirubin ≤1.5X institutional upper limit of normal (ULN)
- Serum AST ≤ 3X institutional ULN
- Serum ALT ≤ 3X institutional ULN
- Serum creatinine ≤1.5X institutional ULN
- Ability to understand and the willingness to sign a written informed consent document (ICD)
Exclusion
- Nasopharyngeal carcinoma
- Prior treatment with P276-00 or other Cyclin dependent kinase (CDK) targeting agents
- History of allergic reactions attributed to compounds of similar chemical composition to P276-00
- Subjects who have received radiotherapy, chemotherapy or biologic/targeted anticancer agents within 60 days prior to Day 1 of study drug administration or have not recovered from adverse effects of any prior radiotherapy, chemotherapy or biologic/targeted agents.
- More than one chemotherapy regimen for the recurrent or metastatic disease
- Subjects who had received any other investigational drug within 1 month or within five half-lives of the other investigational agent, whichever is longer prior to Day 1 of study drug administration
- Subjects with QTc \> 450 msec on 12 lead standard electrocardiogram (ECG)
- History of unstable angina or myocardial infarction or stroke within previous 6 months
- Subjects with uncontrolled inter-current illness including, but not limited to active infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Subjects known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B
- Known brain metastasis
- History of prior malignancy except for curatively treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years
- Women who are pregnant or lactating
- Women of childbearing potential \[defined as sexually mature women who have not undergone hysterectomy or who have not been naturally postmenopausal for at least 24 consecutive months (i.e. who have had menses any time in the preceding 24 consecutive months)\] and men, not agreeing to use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) prior to study entry (after signing the ICD), during the period of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilized
- Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at an unacceptable risk or deems the subject not suitable for participation in the study
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00824343
Start Date
September 1 2008
End Date
June 1 2013
Last Update
July 10 2013
Active Locations (9)
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1
Bharath Hospital & Institute of Oncology, Mysore
Mysore, Karnataka, India, 570017
2
Regional Cancer Centre
Trivandrum, Kerala, India, 695011
3
Kashyap Nursing Home
Mumbai, Maharashtra, India, 400014
4
Jaslok Hospital, Mumbai
Mumbai, Maharashtra, India, 400026