Clinical trial • Phase II • Oncology
Imatinib mesylate for Acute lymphoblastic leukemia (Ph+) | Chronic myeloid leukemia (Ph+)
Phase II trial of Imatinib mesylate for Acute lymphoblastic leukemia (Ph+) | Chronic myeloid leukemia (Ph+).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Acute lymphoblastic leukemia (Ph+) | Chronic myeloid leukemia (Ph+)
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-01-2026
- First CTIS Authorization Date
- 05-05-2026
Trial design
Randomised, open-label, imatinib mesylate tablets 400 mg (sun pharmaceutical industries limited) versus glivec (imatinib mesylate) coated tablets 400 mg (novartis) - single-dose, two-treatment, two-period, two-sequence, crossover bioequivalence design (single 400 mg dose, fed condition).-controlled, crossover Phase II trial across 1 site in Romania.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Imatinib Mesylate Tablets 400 mg (Sun Pharmaceutical Industries Limited) versus Glivec (Imatinib mesylate) coated tablets 400 mg (Novartis) - single-dose, two-treatment, two-period, two-sequence, crossover bioequivalence design (single 400 mg dose, fed condition).
- Crossover
- Yes
- Target Sample Size
- 28
Eligibility
Recruits 28 isVulnerablePopulationSelected: true; vulnerable population type not specified in the record; no consent or assent handling details provided..
- Vulnerable Population
- isVulnerablePopulationSelected: true; vulnerable population type not specified in the record; no consent or assent handling details provided.
Recruitment
- Planned Sample Size
- 28
- Recruitment Window Months
- 2
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 28
Romania
- Earliest CTIS Part Ii Submission Date
- 27-03-2026
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 39
- Number Of Sites
- 1
- Number Of Participants
- 28
Sites
- Site Name
- Terapia S.A.
- Department Name
- Clinical Pharmacology and Pharmacokinetics
- Principal Investigator Name
- Elena Timofte
- Principal Investigator Email
- Elena.Timofte@sunpharma.com
- Contact Person Name
- Elena Timofte
- Contact Person Email
- Elena.Timofte@sunpharma.com
Sponsor
Primary sponsor
- Full Name
- Sun Pharmaceutical Industries Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- India
Investigational products
- Investigational Product Name
- Imatinib Mesylate Tablets 400 mg (manufactured by Sun Pharmaceutical Industries Limited)
- Active Substance
- Imatinib mesylate
- Modality
- Small molecule
- Routes Of Administration
- Oral (tablets)
- Route
- oral
- Starting Dose
- 400 mg
- Dose Levels
- 400 mg (single-dose)
- Frequency
- single-dose
- Maximum Dose
- 400 mg
- Investigational Product Name
- Glivec® (Imatinib mesylate) Coated tablets 400 mg (Novartis)
- Active Substance
- Imatinib mesylate
- Modality
- Small molecule
- Routes Of Administration
- Oral (tablets)
- Route
- oral
- Starting Dose
- 400 mg
- Dose Levels
- 400 mg (single-dose)
- Frequency
- single-dose
- Maximum Dose
- 400 mg
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