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Squamous Cell Carcinoma of Head and NeckPhase 1/2SPARKNCT00899054

Safety and Efficacy Study of P276-00 in Combination With Radiation in Subjects With Advanced Head and Neck Cancer

A Phase 1/2 study testing P276-00 and External beam radiotherapy (EBRT) in people with Squamous Cell Carcinoma of Head and Neck, run by Piramal Enterprises Limited at 6 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

The purpose of this study is to identify a dose of P276-00 that can be safely administered along with Radiation and to examine safety and efficacy of the combination in treatment of advanced head and neck cancer. 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 and External beam radiotherapy (EBRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
6 sitesIndia
Study dates
Aug 2009to Nov 2012
Phase
Phase 1/2
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

  • Disease specifications:
  • Phase I component: Radiation naïve subjects with histologically and/ or cytologically confirmed squamous cell carcinoma of head and neck that is non-metastatic, unresectable and recurrent. Radiation naïve subjects with non-recurrent, non-metastatic, unresectable, disease can also be enrolled if he/she is intolerant to and/or unwilling for chemoradiotherapy involving standard cytotoxic agents (e.g. cisplatin, carboplatin, oxaliplatin, 5-FU, taxanes, methotrexate, etc)
  • Phase II component: Radiation naïve subjects with non-recurrent, non-metastatic, unresectable, locally advanced squamous cell carcinoma of head and neck who are intolerant to and/or unwilling for chemoradiotherapy involving standard cytotoxic agents (e.g. cisplatin, carboplatin, oxaliplatin, 5-FU, taxanes, methotrexate, etc).
  • Treatment specifications:
  • Phase I Component: subjects must not have received any treatment (chemotherapy, targeted or biologic agents, radiotherapy, surgery etc) for the recurrent disease.
  • Phase II Component: The subjects must not have been curatively operated for the disease.
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  • Subjects must have completed any prior chemotherapy, biologic/targeted anti-cancer therapy or surgery at least 4 weeks (at least 6 weeks for nitrosureas and mitomycin C) before initiation of protocol treatment and subjects must have recovered (to < or = grade 1) from the toxic effects from any prior therapy
  • Measurable disease as per RECIST criteria.
  • Age > or = 18 years
  • ECOG (Eastern Cooperative Oncology Group) performance status < or = 2
  • Life expectancy of at least 12 weeks
  • Normal organ and marrow function:
  • Hemoglobin > or = 100 g/L
  • Leukocytes > or = 3 x 109/L
  • Absolute Neutrophil Count (ANC)> or = 1.5 x 109/L
  • Platelets > or = 75 x 109/L
  • Total bilirubin < or = 1.5 X institutional Upper Limit of Normal (ULN)
  • AST(SGOT)< or = 2.5 X institutional ULN
  • ALT(SGPT)< or = 2.5 X institutional ULN
  • Creatinine < or = 1.5 X institutional ULN
  • Ability to understand and willingness to sign a written informed consent document.

Who cannot join

  • Nasopharyngeal carcinoma
  • Subjects who had received any other investigational drug within 1 month prior to day 1 of study drug administration or who have not recovered (to < or = grade 1) from adverse effects of the investigational agent received prior to this period.
  • History of unstable angina or myocardial infarction or stroke within 6 months prior to initiation of protocol treatment.
  • QTcF > 450 msec
  • Subjects with uncontrolled inter-current illness including, but not limited to active infection, symptomatic congestive heart failure, cardiac arrhythmia, psychiatric illness or any condition that would limit compliance with study requirements.
  • Subjects known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B.
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  • Women who are pregnant or lactating.
  • Women of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months)] and men, not agreeing to use at least two approved methods of contraception, including at least one barrier method prior to study entry (after signing the informed consent document), during the duration of study participation and for at least 4 weeks after withdrawal from the study drug, unless they are surgically sterilised.
  • 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

6 sites in 1 country.

6 sites in 1 country

India6 sites

  • Government Medical College

    Chhatrapati Sambhajinagar, Maharashtra, 431001

  • V. N. Cancer Centre, GKNM Hospital

    Coimbatore, Tamil Nadu, 641037

  • Bhagwan Mahawir Cancer Hospital & Research Centre

    Jaipur, Rajasthan, 302017

  • Meenakshi Mission Hospital & Research Centre

    Madurai, Tamil Nadu, 625107

  • Curie Manavata Cancer Center

    Nashik, Maharashtra, 422 004

  • Christian Medical College

    Vellore, Tamil Nadu, 632 004

Other trials in India

About this study

Official title: An Open Label, Multicenter Phase I/II Study Of Selective Cyclin Dependent Kinase Inhibitor P276-00 In Combination With Radiation In Subjects With Recurrent And/Or Locally Advanced Squamous Cell Carcinoma Of Head And Neck

The purpose of this study is to identify a dose of P276-00 that can be safely administered along with Radiation and to examine safety and efficacy of the combination in treatment of advanced head and neck cancer.

Read the detailed description

This is an open label single arm multicenter trial to evaluate safety and efficacy of P276-00 in combination with radiation in patients with recurrent and/or locally advanced squamous cell carcinoma of head and neck. The Primary objective of this study is to determine maximum tolerated dose (MTD) and dose limiting toxicity (ies) (DLT/s) of P276-00 in combination with radiation in subjects with recurrent and/or locally advanced squamous cell carcinoma of head and neck (SCCHN). The Secondary objectives are 1. To evaluate safety and tolerability of the combination regimen of P276-00 and radiation in the study population 2. To analyze pharmacokinetics (PK) of P276-00 in the study population 3. To evaluate efficacy of the combination regimen of P276-00 and radiation in the study population 4. To perform exploratory analysis of biomarkers associated with use of P276-00 and radiation in the study population. In phase 1 component,a cohort of 3 subjects will be enrolled at starting dose level of P276-00 which is 100 mg/m2/day to be given intravenously from day 1 to day 5 in 21 day cycle for 2 cycles in combination with radiation. If this dose is well tolerated then next cohort will be enrolled at higher dose level of P276-00. P276-00 dose escalation will continue until MTD of P276-00 in combination with Radiation is determined. The subsequent dose levels of P276-00 will be 140 mg/m2/day and 185 mg/m2/day.

In phase 2 component 10 subjects will be enrolled at this MTD of P276-00 in combination with radiation to evaluate efficacy. Dose of radiation for both phases is 60 Gy over 6 weeks. Safety evaluations will be conducted at regular intervals during the study. Tumor measurements will be undertaken at baseline, at the end of cycle 2 and 5 to 6 weeks after end of cycle 2. Response evaluation will be performed by Response Evaluation Criteria in Solid Tumors (RECIST). Subjects showing stable disease or better response at the last assessment will be followed up for tumor measurements until progression or recurrence of disease.

Being tested
P276-00, External beam radiotherapy (EBRT)
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

    P276-00 will be administered at different dose levels: level 1: 100 mg/m2/day dose level 2: 140 mg/m2/day dose level 3: 185 mg/m2/day to be given from day 1 to day 5 every 21 days for 2 cycle. P276-00 will be administered as intravenous infusion in 200 ml 5% Dextrose over 30 min from days 1 to 5 per 21 day cycle for two cycles.

  • External beam radiotherapy (EBRT)Radiation

    Also called Radiotherapy

    All subjects will receive external beam radiotherapy (EBRT)by using standard conventional fractionation i.e. 2 Gy per day for 5 days a week for a total radiation dose of 60 Gy over 6 weeks followed by upto 10 additional Gy if required.

Study groups in NCT00899054
Study groupRoleWhat they receive
P276-00 plus RadiationExperimentalP276-00: Level 1:100 mg/m2/day x 5 q 3 weeks, level 2:140 mg/m2/day x 5 q 3 weeks, level 3: 185 mg/m2/day x 5 q 3 weeks. External beam radiotherapy (EBRT): 2 Gy per day for 5 days a week for a total radiation dose of 60 Gy over 2 cycles (6 weeks)followed by upto 10 additional Gy if required
Receives: Drug: P276-00; Radiation: External beam radiotherapy (EBRT)

What is being measured

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

  1. To determine the maximum tolerated dose (MTD) and dose limiting toxicity (ies) (DLT/s) of P276-00 in combination with radiation in subjects with recurrent and/or locally advanced squamous cell carcinoma of head and neck (SCCHN)

    Measured: 3 weeks

Secondary outcomes (4)

  1. To evaluate safety and tolerability of the combination regimen of P276-00 and radiation in the study population

    Measured: Every week

  2. To analyze pharmacokinetics (PK) of P276-00 in the study population

    Measured: Day 2 and Day 5 of Cycle 1

  3. To evaluate efficacy of the combination regimen of P276-00 and radiation in the study population

    Measured: Every 6 weeks

  4. To perform exploratory analysis of biomarkers associated with use of P276-00 and radiation in the study population

    Measured: Day 1 and Day 4

Timeline

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

  1. First posted12 May 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionJan 2011
  4. Study completionNov 2012

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00899054
Sponsor's protocol ID
P276-00/31/08
Other IDs
P276-00/31/08
Acronym
SPARK
Status last verified
Nov 2012
First submitted
6 May 2009
Last updated
22 Nov 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing P276-00 and External beam radiotherapy (EBRT) in people with Squamous Cell Carcinoma of Head and Neck, run by Piramal Enterprises Limited at 6 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 21 inclusion and 9 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 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

To determine the maximum tolerated dose (MTD) and dose limiting toxicity (ies) (DLT/s) of P276-00 in combination with radiation in subjects with recurrent and/or locally advanced squamous cell carcinoma of head and neck (SCCHN) (time frame: 3 weeks). 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 NCT00899054.

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 22 Nov 2012.

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