AzTrials
AzTrials

NeoplasmPhase 1NCT00407498

Open Label Phase I Study of P276-00 in Patients With Advanced Refractory Neoplasms

A Phase 1 study testing P276-00 in people with Neoplasm, run by Piramal Enterprises Limited at 3 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

P276-00 is specific Cdk4-D1 and Cdk1-B inhibitor. P276-00 exhibited significant tumour reduction in animal models with less adverse effects.Based on the results from various in-vitro studies, P276-00 could be a potential candidate as a new mechanism based drug for the treatment of cancer.This Phase I study will… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm
What is being tested?
P276-00
How many people
50 participants
Where
3 sitesin 2 countries
Study dates
May 2005to Sep 2008
Phase
Phase 1
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

  • Patients must have histologically and/ or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
  • Patients of either sex, of all races and ethnic groups, and > 18 years of age
  • ECOG (Eastern Cooperative Oncology Group) performance status < 2
  • Patients with life expectancy of at least 4 months.
  • Patients must have normal organ and marrow function as defined below:
  • absolute neutrophil count ≥ 1,500/mL
Show all 14Show fewer
  • platelets ≥ 100,000/mL
  • total bilirubin within normal institutional limits
  • AST/ALT ≤ 2.5 X institutional upper limit of normal (ULN)
  • creatinine within 1.5 times the upper normal institutional limits
  • The effects of P276-00 on the developing human foetus are unknown. For this reason women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study.
  • Concomitant medications for diabetes, hypertension, pain relief and any other co-existing conditions, except cancer, are permitted when the patient is on study medication. There should be no change in the dosage of these medications in the 2 weeks prior to day 1 of cycle 1, with the exception of dosages for pain relief medication. Changes in the dose of anti-emetics and diuretics may be made provided they will not interfere with probable adverse effects of investigational product.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients must have measurable disease.

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study (date of consent); or patients who have not recovered from adverse events (except grade 1 toxicities) due to agents administered more than 4 weeks earlier.
  • Patients having received any other investigational agents within 4 weeks prior to the date of consent and patients who have not recovered completely from the side effects of the earlier investigational agent.
  • Patients with known brain metastases should be excluded from this clinical trial.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to P276-00.
  • Patients having history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months.
  • Patients having diarrhoea requiring anti-diarrhoeal therapy.
Show all 10Show fewer
  • Patients with uncontrolled and unstable intercurrent illness.
  • Women who are pregnant or nursing. P276-00 may have the potential for teratogenic or abortifacient effects. Since there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with P276-00, breastfeeding should be discontinued if the mother is to be treated with P276-00.
  • Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded from the study.
  • Patients requiring the use of concomitant medications that prolong the QT/QTc interval and /or are known to cause Torsades de Pointes (TdP)

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Canada2 sites

  • Juravinsky Cancer Centre

    Hamilton, Ontario, L8V5C2

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

Other trials in Canada

India1 site

  • Nizam's Institute of Medicai Sciences

    Hyderabaad, Andhrapradesh, 500082

Other trials in India

About this study

Official title: An Open Label Multicentric Phase 1 Study of Selective Cyclin Dependent Kinase Inhibitor P276-00 in Patients With Advanced Refractory Neoplasms

P276-00 is specific Cdk4-D1 and Cdk1-B inhibitor. P276-00 exhibited significant tumour reduction in animal models with less adverse effects.Based on the results from various in-vitro studies, P276-00 could be a potential candidate as a new mechanism based drug for the treatment of cancer.This Phase I study will determine the Maximum Tolerated Dose,Dose Limiting Toxicity and efficacy of P 276-00 in patients with advanced Refractory neoplasms.

Conditions
Neoplasm
Being tested
P276-00
Keywords
P 276-00, Advanced Refractory Neoplasm, Maximum Tolerated Dose, Dose Limiting Toxicity, Pharmacokinetics
Medical subject headings
Neoplasms

What participants receive

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

  • P276-00Drug

    Starting dose of 9 mg/m2/day from day 1to 5 and day 8 to 12 in 21 day cycle.Protocol wa amended to dose the subjects for day 1 to5 in 21 day cycle after 34.4 mg/m2/day cohort.Maximum dose administered was 259 mg/m2/day

What is being measured

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

  1. To determine the maximum tolerated dose and dose limiting toxicity of selective Cdk inhibitor P276-00 in patients with advanced refractory neoplasms.

    Measured: DLT to be seen for cycle 1.Adverse events as and when they occur during the trial duration and till their resolution after exit from study

Secondary outcomes (1)

  1. To determine the toxic effects, pharmacokinetics and clinical response of this regimen.

    Measured: Pharmacokinetics on day 1 and 5 of cycle 1, clinical response after every 2 cycles, toxic effects of the drug as and when they occur to be evaluated

Timeline

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

  1. First posted5 Dec 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionMar 2008
  4. Study completionSep 2008

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00407498
Sponsor's protocol ID
P276-00/01/04
Status last verified
Dec 2008
First submitted
4 Dec 2006
Last updated
1 Jan 2009
Results posted
No
Data monitoring committee
No

Publications

  • Hirte H.W, Raghunatharao D, Baetz S, Hotte J, Rajappa S, Iaccobucci A, Sharma S, Parikh H, Kulkarni S, Patil S, Padigaru M, Gaston S. A Phase I study of the selective cyclin dependant kinase inhibitor P276-00 in Patients with advanced refractory neoplasms. AACR 2007 Abstract number #802

  • Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.

    PubMed 19238148

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing P276-00 in people with Neoplasm, run by Piramal Enterprises Limited at 3 sites in 2 countries.

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 10 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 1 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada, 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 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.

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 and dose limiting toxicity of selective Cdk inhibitor P276-00 in patients with advanced refractory neoplasms. (time frame: DLT to be seen for cycle 1.Adverse events as and when they occur during the trial duration and till their resolution after exit from study). 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 NCT00407498, which also lists 2 linked publications.

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 1 Jan 2009; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in