Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions

NCT02103322 | Completed Phase 2 DMC

• 1 other identifier: ARL/CT/13/001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chronic Myeloid Leukemia; Gastrointestinal Stromal Tumor

Outcome Measures

Primary Outcomes (2)

• Cmax

  Peak maximum concentration over dosing interval in the steady state

  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

  Days 5, 6, 7, 12, 13, 14 and 15

Secondary Outcomes (5)

• Tmax

  Days 5, 6, 7, 12, 13, 14 and 15

• Cmin

  Days 5, 6, 7, 12, 13, 14 and 15

• Cavg

  Days 5, 6, 7, 12, 13, 14 and 15

• Swing

  Days 5, 6, 7, 12, 13, 14 and 15

• Fluctuation Rate

  Days 5, 6, 7, 12, 13, 14 and 15

Study Arms (2)

Imatinib Mesylate Tablets, 400 mg

EXPERIMENTAL

Imatinib Mesylate Tablets, 400 mg. Once daily for 14 days.

Drug: Imatinib Mesylate Tablets, 400 mg

Gleevec Tablets, 400 mg

ACTIVE COMPARATOR

Imatinib Mesylate Tablets, 400 mg. Once daily for 14 days.

Drug: Imatinib Mesylate Tablets, 400 mg

Interventions

Imatinib Mesylate Tablets, 400 mg DRUG

Brown, oval, scored, film coated, beveled edge tablet. Debossed with AN on scored side and 795 on the other side.

Imatinib Mesylate Tablets, 400 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amneal Pharmaceuticals, LLC: lead
• Accutest Research Laboratories (I) Pvt. Ltd.: collaborator

Study Sites (5)

Kailash Cancer Hospital & Research Centre

Vadodara, Gujurat, 391760, India

Location

Srinivasam Cancer Care Hospitals India Pvt.

Bangalore, Karnataka, 560076, India

Location

Karnataka Caner Hospital

Bengaluru, Karnataka, 560096, India

Location

Lokmaya Hospital

Pune, Maharashtra, 411044, India

Location

Dr. G Viswanathan Speciality Hospitals

Tiruchirappalli, Tamil Nadu, 620 008, India

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Ashutosh Jani, MD

  Accutest Research Laboratories (I) Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 3, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 27, 2014

Record last verified: 2014-06

Locations

IN (5)