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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

Phase 2
18 Years
Open (Enrolling)
Squamous Cell Carcinoma of Head and Neck

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Trial Information

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

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.

Inclusion Criteria:

1. Age more than or equal to 18 years

2. 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.

3. 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)

4. Tumor that is accessible to biopsy

5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

6. Life expectancy of at least three months

7. Hemoglobin ≥ 8.0 gm/dL

8. Absolute neutrophil count (ANC) ≥ 1000/mm3

9. Platelet count ≥ 50,000/mm3

10. Total bilirubin ≤1.5X institutional upper limit of normal (ULN)

11. Serum AST ≤ 3X institutional ULN

12. Serum ALT ≤ 3X institutional ULN

13. Serum creatinine ≤1.5X institutional ULN

14. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Nasopharyngeal carcinoma

2. Prior treatment with P276-00 or other Cyclin dependent kinase (CDK) targeting agents

3. History of allergic reactions attributed to compounds of similar chemical composition
to P276-00

4. 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.

5. More than one chemotherapy regimen for the recurrent or metastatic disease

6. 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

7. Subjects with QTc > 450 msec on 12 lead standard electrocardiogram (ECG)

8. History of unstable angina or myocardial infarction or stroke within previous 6

9. 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

10. Subjects known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or
Hepatitis B

11. Known brain metastasis

12. 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

13. Women who are pregnant or lactating

14. 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

15. 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

Tumor measurements to be undertaken at baseline and at the end of every 2 cycles. Response evaluation to be performed on the basis of RECIST criteria

Safety Issue:


Principal Investigator

Dr. Ajay Mehta

Investigator Role:

Principal Investigator

Investigator Affiliation:

Director and Onco-Surgeon, Central India Cancer Research Institute, Nagpur


India: Drugs Controller General of India

Study ID:




Start Date:

September 2008

Completion Date:

Related Keywords:

  • Squamous Cell Carcinoma of Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms