NeoplasmPhase 1NCT00408018
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 India.
Trial summary
P276-00 is a molecule derived from Rohitukine, which through pre clinical assays was identified as a selective Cdk4-D1 and Cdk1-B inhibitor.The inhibition of these Cdks causes cell cycle arrest between the G1-S transition thus blocking the cell cycle events at an early stage of development. 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
- 28 participants
- Where
- 3 sitesIndia
- Study dates
- Mar 2006to Oct 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:
- Hemoglobin ≥10 gm/dL
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- absolute neutrophil count ≥ 1,500/mL
- 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) for the duration of the study during the duration of study participation and for at least 4 weeks after withdrawal from the study.
- Women who are nursing should not be included into 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.
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 diarrhea requiring anti-diarrheal therapy.
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- Patients having coagulopathy requiring anticoagulation.
- Patients with uncontrolled but stable intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- 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 1 country.
India3 sites
Nizam's Institute of Medicai Sciences
Hyderabaad, Andhra Pradesh, 500082
Global Hospital
Hyderabad, Andhra Pradesh
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
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 a molecule derived from Rohitukine, which through pre clinical assays was identified as a selective Cdk4-D1 and Cdk1-B inhibitor.The inhibition of these Cdks causes cell cycle arrest between the G1-S transition thus blocking the cell cycle events at an early stage of development. It therefore has the potential for being efficacious with lesser side effects.
- Conditions
- Neoplasm
- Being tested
- P276-00
- 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
Potent Cyclin dependent kinase (cdk) cdk4 D1, cdk1 B and cdk9 T inhibitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment by Laboratory investigations (Hematology,Biochemistry, urinalysis), ECG, Holter monitoring,Physical examination
Measured: 2 years
Secondary outcomes (1)
Tumor measurements,Pharmacokinetics, MALDI- TOF to study plasma peptide pattern
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startMar 2006
- Primary completionAug 2008
- Study completionOct 2008
Why it stopped: The decision to terminate this study after 202 mg/m2 cohort was taken as MTD achieved in other study at 185 mg/m2
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Enterprises Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Purvish M parikh, MD, DNB, PhD, Principal investigator, Tata Memorial HospitalRaghunadharao D, MD, DM, Principal investigator, Nizam's Institute of Medical SciencesRavikumar Saxena, MD, Principal investigator, Global Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408018
- Sponsor's protocol ID
- P276-00/02/05
- Status last verified
- Dec 2008
- First submitted
- 4 Dec 2006
- Last updated
- 1 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Multicentric Phase 1 Study of Selective Cyclin Dependent Kinase Inhibitor P276-00 in Patients With Advanced Refractory Neoplasms
- ClinicalTrials.gov ID
- NCT00408018
- Acronym / sponsor ID
- P276-00/02/05
- Conditions
- Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to terminate this study after 202 mg/m2 cohort was taken as MTD achieved in other study at 185 mg/m2
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Piramal Enterprises LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
P276-00 is a molecule derived from Rohitukine, which through pre clinical assays was identified as a selective Cdk4-D1 and Cdk1-B inhibitor.The inhibition of these Cdks causes cell cycle arrest between the G1-S transition thus blocking the cell cycle events at an early stage of development. It therefore has the potential for being efficacious with lesser side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P276-00Potent Cyclin dependent kinase (cdk) cdk4 D1, cdk1 B and cdk9 T inhibitor | Drug | – |
Primary outcome
Safety assessment by Laboratory investigations (Hematology,Biochemistry, urinalysis), ECG, Holter monitoring,Physical examination
Time frame: 2 years
1 secondary outcome
Tumor measurements,Pharmacokinetics, MALDI- TOF to study plasma peptide pattern
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The decision to terminate this study after 202 mg/m2 cohort was taken as MTD achieved in other study at 185 mg/m2). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Purvish M parikh, MD, DNB, PhD principal investigator
Tata Memorial Hospital
Raghunadharao D, MD, DM principal investigator
Nizam's Institute of Medical Sciences
Ravikumar Saxena, MD principal investigator
Global Hospital
3 sites in 1 country: see every site and its status.
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 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 15 inclusion and 11 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: stopped early, 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 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 was stopped early (reason given: The decision to terminate this study after 202 mg/m2 cohort was taken as MTD achieved in other study at 185 mg/m2). Results are not available in the source record.
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?
Safety assessment by Laboratory investigations (Hematology,Biochemistry, urinalysis), ECG, Holter monitoring,Physical examination (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.