Chronic Myeloid LeukemiaPhase 2/3NCT02103322
Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions
A Phase 2/3 study testing Imatinib Mesylate Tablets, 400 mg in people with Chronic Myeloid Leukemia and Gastrointestinal Stromal Tumor, run by Amneal Pharmaceuticals, LLC at 5 sites in India.
Trial summary
To characterize pharmacokinetic profile of test product compared to that of the corresponding reference product in adult patients, who are diagnosed to have Chronic Myeloid Leukemia \& Gastrointestinal Stromal Tumor under Fed Conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor
- What is being tested?
- Imatinib Mesylate Tablets, 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesIndia
- Study dates
- Feb 2014to Jun 2014
- Phase
- Phase 2/3
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 55 years (both inclusive) and either sex
- Diagnosed case of Philadelphia chromosome positive (Ph+) CML patients in chronic phase or GIST and presently being treated with imatinib 400 mg tablets.
- Willing to give written informed consent for participation in the study as well as willing and able to comply with study visit schedule and other protocol requirements.
- Female patients of child bearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing, must be non-lactating at screening and must agree to use effective contraception (barrier or hormonal) for the study period.
Who cannot join
- History of hypersensitivity to imatinib mesylate or to any of the excipients as judged by investigator.
- Patient of CML receiving treatment in Myeloid Blast Crisis or Accelerated Phase
- Abnormal laboratory results as below:
- History of a heart failure, renal insufficiency, hypereosinophilic syndrome (HES), myelodysplastic syndrome (MDS)/ myeloproliferative disease (MPD) or acute systemic mastocytosis (ASM).
- History of therapy with any of the following as per timelines before randomization: inducers of CYP3A4 activity and inhibitors of CYP3A4 activity, within 14 days, investigational product/device within last one month
- Alcohol or any drug dependence within past one year.
- Blood donation/loss exceeding 200 ml within last 60 days.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Srinivasam Cancer Care Hospitals India Pvt.
Bangalore, Karnataka, 560076
Karnataka Caner Hospital
Bengaluru, Karnataka, 560096
Lokmaya Hospital
Pune, Maharashtra, 411044
Dr. G Viswanathan Speciality Hospitals
Tiruchirappalli, Tamil Nadu, 620 008
Kailash Cancer Hospital & Research Centre
Vadodara, Gujurat, 391760
About this study
Official title: A Randomized, Open Label, Two-Treatment, Multiple Dose, Steady State, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Imatinib Mesylate Tablet 400 mg of Amneal Pharmaceuticals, USA With GLEEVEC® (Imatinib Mesylate) Tablets 400 mg Distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions
To characterize pharmacokinetic profile of test product compared to that of the corresponding reference product in adult patients, who are diagnosed to have Chronic Myeloid Leukemia \& Gastrointestinal Stromal Tumor under Fed Conditions.
Read the detailed description
To characterize pharmacokinetic profile of Imatinib Mesylate tablets EQ 400 mg base of Amneal Pharmaceuticals LLC, compared to that of the reference product - GLEEVEC® (imatinib mesylate) tablets 400 mg in adult patients, who are diagnosed to have CML or GIST and are presently receiving stable dose of imatinib mesylate tablets 400 mg, and assess their bioequivalence.
- Being tested
- Imatinib Mesylate Tablets, 400 mg
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib Mesylate Tablets, 400 mgDrug
Brown, oval, scored, film coated, beveled edge tablet. Debossed with AN on scored side and 795 on the other side.
Imatinib Mesylate Tablets, 400 mgDrug
Also called Gleevec
Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with "400" on one side with score on the other side, and "SL" on each side of the score.
| Study group | Role | What they receive |
|---|---|---|
| Imatinib Mesylate Tablets, 400 mg | Experimental | Imatinib Mesylate Tablets, 400 mg. Once daily for 14 days. Receives: Drug: Imatinib Mesylate Tablets, 400 mg |
| Gleevec Tablets, 400 mg | Active comparator | Imatinib Mesylate Tablets, 400 mg. Once daily for 14 days. Receives: Drug: Imatinib Mesylate Tablets, 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak maximum concentration over dosing interval in the steady state
Measured: Days 5, 6, 7, 12, 13, 14 and 15
AUC0-tau
The area under the blood concentration curve versus time, calculated by the trapezoid method, from zero time to the dose interval (tau) in the steady state
Measured: Days 5, 6, 7, 12, 13, 14 and 15
Secondary outcomes (5)
Tmax
The time to reach such peak over dosing interval in the steady state
Measured: Days 5, 6, 7, 12, 13, 14 and 15
Cmin
Minimum concentration established at each dose interval end of the steady state
Measured: Days 5, 6, 7, 12, 13, 14 and 15
Cavg
Average concentration in the steady state (= AUC0-tau / tau)
Measured: Days 5, 6, 7, 12, 13, 14 and 15
Swing
Swing in steady state pharmacokinetics, calculated as (CmaxSS-CminSS)/ CminSS
Measured: Days 5, 6, 7, 12, 13, 14 and 15
Fluctuation Rate
Degree of fluctuation in the steady state pharmacokinetics, calculated as (Cmax-Cmin)/CavSS
Measured: Days 5, 6, 7, 12, 13, 14 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accutest Research Laboratories (I) Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- Ashutosh Jani, MD, Principal investigator, Accutest Research Laboratories (I) Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103322
- Sponsor's protocol ID
- ARL/CT/13/001
- Status last verified
- Jun 2014
- First submitted
- 1 Apr 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Two-Treatment, Multiple Dose, Steady State, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Imatinib Mesylate Tablet 400 mg of Amneal Pharmaceuticals, USA With GLEEVEC® (Imatinib Mesylate) Tablets 400 mg Distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions
- ClinicalTrials.gov ID
- NCT02103322
- Acronym / sponsor ID
- ARL/CT/13/001
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Amneal Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Accutest Research Laboratories (I) Pvt. Ltd.
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Apr 2014 (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.
To characterize pharmacokinetic profile of test product compared to that of the corresponding reference product in adult patients, who are diagnosed to have Chronic Myeloid Leukemia \& Gastrointestinal Stromal Tumor under Fed Conditions.
Detailed description
To characterize pharmacokinetic profile of Imatinib Mesylate tablets EQ 400 mg base of Amneal Pharmaceuticals LLC, compared to that of the reference product - GLEEVEC® (imatinib mesylate) tablets 400 mg in adult patients, who are diagnosed to have CML or GIST and are presently receiving stable dose of imatinib mesylate tablets 400 mg, and assess their bioequivalence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imatinib Mesylate Tablets, 400 mg | Experimental | Drug: Imatinib Mesylate Tablets, 400 mgImatinib Mesylate Tablets, 400 mg. Once daily for 14 days. |
| Gleevec Tablets, 400 mg | Active comparator | Drug: Imatinib Mesylate Tablets, 400 mgImatinib Mesylate Tablets, 400 mg. Once daily for 14 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 55 years (both inclusive) and either sex
- Diagnosed case of Philadelphia chromosome positive (Ph+) CML patients in chronic phase or GIST and presently being treated with imatinib 400 mg tablets.
- Willing to give written informed consent for participation in the study as well as willing and able to comply with study visit schedule and other protocol requirements.
- Female patients of child bearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing, must be non-lactating at screening and must agree to use effective contraception (barrier or hormonal) for the study period.
Key exclusion criteria (7 listed)
- History of hypersensitivity to imatinib mesylate or to any of the excipients as judged by investigator.
- Patient of CML receiving treatment in Myeloid Blast Crisis or Accelerated Phase
- Abnormal laboratory results as below:
- History of a heart failure, renal insufficiency, hypereosinophilic syndrome (HES), myelodysplastic syndrome (MDS)/ myeloproliferative disease (MPD) or acute systemic mastocytosis (ASM).
- History of therapy with any of the following as per timelines before randomization: inducers of CYP3A4 activity and inhibitors of CYP3A4 activity, within 14 days, investigational product/device within last one month
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 |
|---|---|---|
| Imatinib Mesylate Tablets, 400 mgBrown, oval, scored, film coated, beveled edge tablet. Debossed with AN on scored side and 795 on the other side. | Drug | Imatinib Mesylate Tablets, 400 mg |
| Imatinib Mesylate Tablets, 400 mgAlso: GleevecVery dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with "400" on one side with score on the other side, and "SL" on each side of the score. | Drug | Gleevec Tablets, 400 mg |
Primary outcome
Cmax
Time frame: Days 5, 6, 7, 12, 13, 14 and 15
Peak maximum concentration over dosing interval in the steady state
AUC0-tau
Time frame: Days 5, 6, 7, 12, 13, 14 and 15
The area under the blood concentration curve versus time, calculated by the trapezoid method, from zero time to the dose interval (tau) in the steady state
5 secondary outcomes
Tmax
Time frame: Days 5, 6, 7, 12, 13, 14 and 15
Cmin
Time frame: Days 5, 6, 7, 12, 13, 14 and 15
Cavg
Time frame: Days 5, 6, 7, 12, 13, 14 and 15
Swing
Time frame: Days 5, 6, 7, 12, 13, 14 and 15
Fluctuation Rate
Time frame: Days 5, 6, 7, 12, 13, 14 and 15
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 27 Jun 2014.
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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.
Ashutosh Jani, MD principal investigator
Accutest Research Laboratories (I) Pvt. Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Imatinib Mesylate Tablets, 400 mg in people with Chronic Myeloid Leukemia and Gastrointestinal Stromal Tumor, run by Amneal Pharmaceuticals, LLC 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 4 inclusion and 7 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 27 Jun 2014. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Cmax (time frame: Days 5, 6, 7, 12, 13, 14 and 15). The study lists 2 primary outcomes in all. 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 27 Jun 2014.