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Squamous Cell Carcinoma of Head and NeckPhase 2MONARCHNCT00824343

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

A Phase 2 study testing P276-00 in people with Squamous Cell Carcinoma of Head and Neck, run by Piramal Enterprises Limited at 9 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
P276-00
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
9 sitesIndia
Study dates
Sep 2008to Jun 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

India9 sites

  • V. N. Cancer Centre, GKNM Hospital,

    Coimbatore, Tamil Nadu, 641037

  • Bhagwan Mahaveer Cancer Hospital & Research Centre, Dept. Of Medical Oncology, Jaipur

    Jaipur, Rajasthan, 302 017

  • Dept. Of Surgical Oncology, CSM Medical University, Lucknow

    Lucknow, Uttar Pradesh, 226003

  • Kashyap Nursing Home

    Mumbai, Maharashtra, 400014

  • Jaslok Hospital, Mumbai

    Mumbai, Maharashtra, 400026

  • Bharath Hospital & Institute of Oncology, Mysore

    Mysore, Karnataka, 570017

  • Central India Cancer Research Institute,

    Nagpur, Maharashtra, 440010

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004

  • Regional Cancer Centre

    Trivandrum, Kerala, 695011

Other trials in India

About this 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

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.

Read the 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.

Being tested
P276-00
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P276-00Drug

    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.

Study groups in NCT00824343
Study groupRoleWhat they receive
Single P276-00 armExperimentalThis is a single experimental arm study
Receives: Drug: P276-00

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Measured: 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

Secondary outcomes (1)

  1. Duration of response, Progression free survival (PFS), Time to progression (TTP), PFS at one year, Overall survival (OS) at one year

    Measured: Tumor measurements at the end of every 2 cycles. Follow up for survival status every 4 weeks after discontinuation of protocol treatment till one year of cycle 1 day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionApr 2011
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00824343
Sponsor's protocol ID
P276-00/21/08
Acronym
MONARCH
Status last verified
Jul 2013
First submitted
15 Jan 2009
Last updated
10 Jul 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing P276-00 in people with Squamous Cell Carcinoma of Head and Neck, run by Piramal Enterprises Limited at 9 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00824343.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.

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