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Imatinib Mesylate Oral Solution 400mg/5ml with GleevecÂ (Imatinib mesylate) Tablets 400mg in adult human subjects with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.

ABSTRACT: Intervention1: Imatinib Mesylate Oral Solution 400mg/5ml: Dose: 5 ml(400mg), Frequency: once Daily, Route of Administration: Oral, Duration: 16 Days Control Intervention1: GleevecÂ (Imatinib mesylate) Tablets 400mg: Dose: Single Dose(1 tablet x 400 mg), Frequency: once Daily, Route of Administration: Oral, Duration: 16 Days Primary outcome(s): To compare and evaluate the multiple dose oral bioavailability of Imatinib Mesylate Oral Solution 400mg/5ml of Shilpa Medicare Limited with GleevecÂ (Imatinib mesylate) Tablets 400mg of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, in adult human patients with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.Timepoint: Day:1-Pre-dose blood sample within 1.00 hour prior to dosing, Day:6 and 14- Pre-dose blood sample (-48.0) and Day:7 and 15- Pre-dose blood sample (-24.0) within 1.00 hour prior to dosing, Day:8and16- Pre-dose blood sample (0.0) within 1 hour prior to dosing for 0.5 hours, 1.0 hrs., 1.5 hrs., 2.0 hrs., 2.5 hrs., 3.0 hrs., 3.5 hrs., 4.0 hrs., 5.0 hrs., 6.0 hrs., 8.0 hrs., 10.0 hrs., 12.0 hrs., 16.0 hrs. within Â± 02 minutes, Day:09and17 24 hrs. within Â± 02 minutes Study Design: Randomized, Crossover Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Open Label

DISEASE(S): Chronic Myeloid Leukemia, Bcr/abl-positive,Malignant Neoplasm Of Intestinal Tract, Part Unspecified

PROVIDER: 2594937 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:The outcome of treating chronic myeloid leukemia (CML) with imatinib mesylate (IM) is inferior when therapy is commenced in late chronic or accelerated phase as compared to early chronic phase. This may be attributed to additional genomic alterations that accumulate during disease progression. We sought to identify such lesions in patients showing suboptimal response to IM by performing array-CGH analysis on 39 sequential samples from 15 CML patients. Seventy-four cumulative copy number alterations (CNAs) consisting of 35 losses and 39 gains were identified. Alterations flanking the ABL1 and BCR genes on chromosomes 9 and 22, respectively, were the most common identified lesions with 5 patients losing variable portions of 9q34.11 proximal to ABL1. Losses involving 1p36, 5q31, 17q25, Y and gains of 3q21, 8q24, 22q11, Xp11 were among other recurrent lesions identified. Aberrations were also observed in individual patients, involving regions containing known leukemia-associated genes; CDKN2A/2B, IKZF1, RB1, TLX1, AFF4. CML patients in late stages of their disease, harbor pre-existing and evolving sub-microscopic CNAs that may influence disease progression and IM response. Fifteen patients with confirmed CML, on IM for a minimum period of 18-months and showing suboptimal response to IM, as evidenced by failure to achieve major molecular remission (MMolR) at 18 months were identified from a series of patients treated in our centre. Patients received their medication under the auspices of the Glivec International Patient Assistance Program (GIPAP) and were started on an initial dose of 400mg with dose escalations or reductions made according to the patientM-bM-^@M-^Ys response and tolerance. Archived sequential peripheral blood lysates from the patients were retrieved and DNA/RNA extracted. Thirty-nine DNA samples of sufficient quality and quantity from the 15 patients were subjected to array-CGH analysis to identify recurrent genomic aberrations that occur through the course of disease.

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Imatinib Mesylate Oral Solution 400mg/5ml with GleevecÂ (Imatinib mesylate) Tablets 400mg in adult human subjects with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.

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