Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Temozolomide Powder for Oral Suspension, 20 mg/mL: Dosage Level: Once daily monotherapy for 10 days over 2 consecutive treatment cycles (5 consecutive days per cycle of 28 days). The in
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Parents/care givers/legally authorized representatives (LARs) must give written informed consent for children under their care. Parents/care givers /LARs must be able to understand and comply with protocol requirements, instructions, and restrictions. 2) Paediatric subjects from 3 to less than 18 years of age at study entry. 3) Subjects with malignant gliomas such as glioblastoma multiforme or anaplastic astrocytoma (anaplastic oligodendrogliomas and anaplastic oligoastrocytomas, and some less common tumours, such as anaplastic ependymomas and anaplastic gangliogliomas). 4) Indicated for oral temozolomide once daily of a calculated individualized dose (e.g., based upon factors such as tumour type, body surface area, cycle number, and anticipated or reported incidence of toxicity) and who are already receiving temozolomide by opening the capsule. 5) For subjects already receiving radiotherapy, a gap of 28 days (4 weeks) must be maintained between the last day of radiotherapy and the day of screening. 6) A life expectancy of at least 3 months. 7) Able to swallow medication as per clinical judgement of treating physician. 8) Karnofsky Performance Score greater than 50 for subjects greater than or equal to 16 to less than 18 years of age OR Lansky score greater than 50 for subjects greater than 3 to less than 16 years of age. 9) Adequate bone marrow function, renal function and hepatic function at the screening visit. 10) A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than 1 percent per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least 12 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of at least 12 months after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. • A WOCBP must have a negative serum pregnancy test at screening; and negative urine pregnancy test before the first dose of study intervention at baseline visit. • If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive. • Additional requirements for pregnancy testing during and after study intervention are located in Appendix 8.2.8. • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. 11) Male subjects are eligible to participate if they agree to the following during the intervention period and for at least 12 months after the last dose of study intervention: • Must agree not to donate sperm for the purpose of reproduction, if its applicable according to the local legislation PLUS EITHER • Be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR • Must agree to use contracept
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to temozolomide, dacarbazine, or any other ingredients of the formulation. 2) Subjects who require temozolomide administration by nasogastic tube. 3) Subjects who are pregnant or breastfeeding. 4) Subjects or their caregivers unable to carry out study assessments and comply with the requirements of the protocol. 5) Currently using medicinal products associated with aplastic anemia, including but not limited to, carbamazepine or phenytoin. 6) Currently known active case of positive for COVID 19 infection. 7) Known galactose intolerance, known deficiency of the Lapp lactase or glucose-galactose malabsorption. 8) Active ulceration of the oral mucosa. 9) Any other condition that, in the investigators judgment, might increase the risk to the subjects or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. 10) The receipt of an investigational medicinal product within a period of 30 days prior to the first dose of study medication for the current study. Elimination half-life of the study drug should be taken into consideration for inclusion of the subjects in the study. 11) Abnormal baseline findings that the Investigator considers might indicate conditions that could affect study endpoints. 12) Female subjects of childbearing potential with positive serum beta human chorionic gonadotropin (β hCG) at the time of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the overall acceptability of Temozolomide Powder for Oral Suspension.Timepoint: Overall acceptability will be assessed according to the rating scales within 10 minutes after dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the taste and smell acceptability of Temozolomide Powder for Oral Suspension.Timepoint: Taste and smell acceptability will be assessed according to the rating scales provided in Appendix VI, within 10 minutes after dosing. | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed