Solid TumorPhase 1SerenityNCT00840190
A Study Of Selective Cyclin Dependent Kinase Inhibitor P1446A-05 In Subjects With Advanced Refractory Malignancies
A Phase 1 study testing P1446A-05 in people with Solid Tumor and Hematologic Malignancy, run by Piramal Enterprises Limited at 5 sites in India.
Trial summary
This is a phase I open label study to evaluate safety and efficacy of P1446A-05 in subjects with advanced refractory malignancies. Subjects of solid tumors or hematologic malignancies will be included. This is a dose escalation study following an accelerated titration design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Hematologic Malignancy
- What is being tested?
- P1446A-05
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 5 sitesIndia
- Study dates
- Dec 2008to Sep 2011
- 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
- Subjects must have histologically and/ or cytologically confirmed solid malignant tumor or hematologic malignancy that is refractory to currently available treatment or for which no standard treatment exists
- Subjects of either sex and more than or equal to 18 years of age
- ECOG (Eastern Cooperative Oncology Group) performance status less than or equal to 2
- Subjects with life expectancy of at least 4 months
- Hemoglobin greater than or equal to 8 g/dl
- Absolute neutrophil count greater than or equal to 1000/mm3
Show all 11Show fewer
- Platelet count greater than or equal to 50,000/ mm3
- Total bilirubin less than or equal to 1.5 X institutional upper limit of normal (ULN)
- AST/ALT less than or equal to 3 X institutional upper limit of normal (ULN)
- Creatinine less than or equal to 1.5 X institutional upper limit of normal (ULN)
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Subjects who have received radiotherapy, chemotherapy or biologic/targeted anticancer agents within 4 weeks prior to day 1 of study drug administration (6 weeks for nitrosoureas or mitomycin C) or have not recovered completely from adverse effects of any prior radiotherapy, chemotherapy or biologic/targeted agents
- Subjects who have received autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration
- Subjects with known brain metastases at the time of screening
- 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 or who have not completely recovered from adverse effects of the investigational agent received prior to this period.
- History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05.
- Subjects on immunosuppressive therapy.
Show all 13Show fewer
- 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.
- History of any other 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 diseasefree for at least 3 years.
- 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 adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) 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, 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
5 sites in 1 country.
5 sites in 1 country
India5 sites
SEAROC Cancer Centre,
Jaipur, Rajasthan, 302013
Bhagwan Mahaveer Cancer Hospital
Jaipur, Rajasthan, 302017
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Ruby Hall Clinic
Pune, Maharashtra, 411 001
Jehangir Hospital
Pune, Maharashtra, 411001
About this study
Official title: An Open Label, Multicenter Phase I Study Of Selective Cyclin Dependent Kinase Inhibitor P1446A-05 In Subjects With Advanced Refractory Malignancies
This is a phase I open label study to evaluate safety and efficacy of P1446A-05 in subjects with advanced refractory malignancies. Subjects of solid tumors or hematologic malignancies will be included. This is a dose escalation study following an accelerated titration design. It is expected that around 50 subjects would be enrolled in the study.Safety assessment will be conducted on the basis of vital signs, physical examination and laboratory investigations undertaken at regular intervals as per the schedule.
Read the detailed description
This is a phase I open label study to evaluate safety and efficacy of P1446A-05 in subjects with advanced refractory malignancies. Subjects of solid tumors or hematologic malignancies will be included as per selection criteria. Starting dose for P1446A-05 in this study is 75 mg orally once daily for 14 days followed by 7 days rest. This constitutes one cycle for P1446A-05.Three patients will be enrolled in first cohort at this starting dose of P1446A-05. If this dose is well tolerated then dose escalation will be undertaken for subsequent cohorts as per accelerated titration design as described in protocol till maximum tolerated dose(MTD) for P1446A-05 is determined. The MTD will be the recommended phase 2 dose. 10 additional patients might be enrolled at this MTD to further evaluate safety and efficacy. It is expected that around 50 subjects would be enrolled in the study.Safety assessment will be conducted on the basis of vital signs, physical examination and laboratory investigations undertaken at regular intervals as per the schedule.
- Conditions
- Solid Tumor, Hematologic Malignancy
- Being tested
- P1446A-05
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1446A-05Drug
P1446A-05 available as 25mg,50mg,100mg capsule. Subjects will be enrolled at at different dose levels of P1446A-05 to be taken once a day for 14 days followed by 7 days rest.This constitutes one cycle of P1446A-05. Four such cycles will be administered.
| Study group | Role | What they receive |
|---|---|---|
| P1446A-05 | Experimental | Not described Receives: Drug: P1446A-05 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of P1446A-05 in subjects with advanced refractory malignancies
Measured: End of cycle 1 (3 weeks)
Secondary outcomes (1)
1 To evaluate safety and tolerability ,pharmacokinetics of P1446A-05 in study population 2. To evaluate efficacy of P1446A-05 3. To perform exploratory analysis of biomarkers associated with use of P1446A-05 in the study population
Measured: End of cycle 1 (3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Enterprises Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minish Jain, M.D., Principal investigator, ConsultantNaresh Somani, D.M., Principal investigator, Sr. Hemato-Oncologist & Pediatric OncologistAnish Maru, D.M., Principal investigator, Senior Consultant and DirectorShona Nag, M.D., Principal investigator, Consultant Medical OncologistSudeep Gupta, D.M., Principal investigator, Oncology Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840190
- Sponsor's protocol ID
- P1446A-05/19/08
- Acronym
- Serenity
- Status last verified
- Nov 2012
- First submitted
- 3 Feb 2009
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Phase I Study Of Selective Cyclin Dependent Kinase Inhibitor P1446A-05 In Subjects With Advanced Refractory Malignancies
- ClinicalTrials.gov ID
- NCT00840190
- Acronym / sponsor ID
- Serenity / P1446A-05/19/08
- Conditions
- Solid Tumor, Hematologic Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Piramal Enterprises LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Feb 2009 (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.
This is a phase I open label study to evaluate safety and efficacy of P1446A-05 in subjects with advanced refractory malignancies. Subjects of solid tumors or hematologic malignancies will be included. This is a dose escalation study following an accelerated titration design. It is expected that around 50 subjects would be enrolled in the study.Safety assessment will be conducted on the basis of vital signs, physical examination and laboratory investigations undertaken at regular intervals as per the schedule.
Detailed description
This is a phase I open label study to evaluate safety and efficacy of P1446A-05 in subjects with advanced refractory malignancies. Subjects of solid tumors or hematologic malignancies will be included as per selection criteria. Starting dose for P1446A-05 in this study is 75 mg orally once daily for 14 days followed by 7 days rest. This constitutes one cycle for P1446A-05.Three patients will be enrolled in first cohort at this starting dose of P1446A-05. If this dose is well tolerated then dose escalation will be undertaken for subsequent cohorts as per accelerated titration design as described in protocol till maximum tolerated dose(MTD) for P1446A-05 is determined. The MTD will be the recommended phase 2 dose. 10 additional patients might be enrolled at this MTD to further evaluate safety and efficacy. It is expected that around 50 subjects would be enrolled in the study.Safety assessment will be conducted on the basis of vital signs, physical examination and laboratory investigations undertaken at regular intervals as per the schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P1446A-05 | Experimental | Drug: P1446A-05 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must have histologically and/ or cytologically confirmed solid malignant tumor or hematologic malignancy that is refractory to currently available treatment or for which no standard treatment exists
- Subjects of either sex and more than or equal to 18 years of age
- ECOG (Eastern Cooperative Oncology Group) performance status less than or equal to 2
- Subjects with life expectancy of at least 4 months
- Hemoglobin greater than or equal to 8 g/dl
Key exclusion criteria (13 listed)
- Subjects who have received radiotherapy, chemotherapy or biologic/targeted anticancer agents within 4 weeks prior to day 1 of study drug administration (6 weeks for nitrosoureas or mitomycin C) or have not recovered completely from adverse effects of any prior radiotherapy, chemotherapy or biologic/targeted agents
- Subjects who have received autologous or allogeneic bone marrow transplant within 6 months of day 1 of study drug administration
- Subjects with known brain metastases at the time of screening
- 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 or who have not completely recovered from adverse effects of the investigational agent received prior to this period.
- History of allergic reactions attributed to compounds of similar chemical structure to P1446A-05.
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 |
|---|---|---|
| P1446A-05P1446A-05 available as 25mg,50mg,100mg capsule. Subjects will be enrolled at at different dose levels of P1446A-05 to be taken once a day for 14 days followed by 7 days rest.This constitutes one cycle of P1446A-05. Four such cycles will be administered. | Drug | P1446A-05 |
Primary outcome
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of P1446A-05 in subjects with advanced refractory malignancies
Time frame: End of cycle 1 (3 weeks)
1 secondary outcome
1 To evaluate safety and tolerability ,pharmacokinetics of P1446A-05 in study population 2. To evaluate efficacy of P1446A-05 3. To perform exploratory analysis of biomarkers associated with use of P1446A-05 in the study population
Time frame: End of cycle 1 (3 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Minish Jain, M.D. principal investigator
Consultant
Naresh Somani, D.M. principal investigator
Sr. Hemato-Oncologist & Pediatric Oncologist
Anish Maru, D.M. principal investigator
Senior Consultant and Director
5 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 P1446A-05 in people with Solid Tumor and Hematologic Malignancy, run by Piramal Enterprises Limited at 5 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 11 inclusion and 13 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 21 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 5 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 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 toxicities (DLT) of P1446A-05 in subjects with advanced refractory malignancies (time frame: End of cycle 1 (3 weeks)). 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 21 Nov 2012.