A Study of Temozolomide 30 mg/ml oral suspension in adult patients with Glioblastoma Multiforme or Anaplastic Astrocytoma under fasting condition.

Not Applicable

• Conditions: Health Condition 1: C719- Malignant neoplasm of brain, unspecified

• Registration Number: CTRI/2021/07/035264
• Lead Sponsor: Shilpa Medicare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

i.Willing and able to provide written informed consent prior to any study-related activities being performed and to follow protocol requirements.

ii.Patients aged 18 to 65 years (both inclusive) having body mass index (BMI) at least 17.00 calculated as weight in kg/height in m².

iii.Patients with Glioblastoma Multiforme or Anaplastic Astrocytoma, who are eligible for Temozolomide 150 mg/m² once daily as their calculated individualized maintenance dose for 5 consecutive days.

iv.Able to swallow and retain oral medications.

v.Non-smokers and non-alcoholics.

vi.Eastern Cooperative Oncology Group (ECOG) performance status <= 2.

vii.Life expectancy of at least 3 months.

viii.Acceptable hematology status:

a) Hemoglobin >= 9 g/dL.

b) Absolute neutrophil count (ANC) >= 1500 cells/µL.

c) Platelet count >= 1,00,000 cells/µL.

ix.Patients with acceptable renal and hepatic function.

x.Male patients must agree to use an effective method of contraception during study and for at least 6 months after receiving the last dose and must seek advice on cryoconservation of sperm prior to treatment.

xi.Women of childbearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the IP) practicing any acceptable methods of contraception Acceptable methods of contraception are:

a.Oral or parenteral (injection), patch or implant hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication.

b.Intrauterine device or intrauterine system.

c.Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent).

d.Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient.

e.Female sterilization (surgical bilateral oophorectomy) or tubal ligation within at least 6 weeks prior to study participation.

f. Total abstinence, partial abstinence is not acceptable.

xii.Female patients with negative serum pregnancy test at screening.

xiii.No history of addiction to any recreational drug or drug dependence or alcohol addiction.

Exclusion Criteria

i.Hypersensitivity or intolerance to temozolomide, dacarbazine (DTIC), ondansetron or to any of the excipients of investigational product.

ii.Patients with severe myelosuppression.

iii.Pregnant or lactating women.

iv.Major surgical procedure (including periodontal) within 28 days of first dose of investigational product.

v.Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.

vi.Patients taking or scheduled to receive any prohibited medications such as Dacarbazine (DTIC), Valproic Acid and Myelosuppressive Agents during the study participation.

vii.Surgical or other non-healing wounds.

viii.History of other malignancies in the last 5 years. Potential patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.

ix.Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), Hemoglobin >= 9 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable), (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0).

x.History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease,hypertension, diabetes mellitus etc.).

xi.Any other medical condition or serious intercurrent illness that, in the opinion of the investigator may make it undesirable for the patient to participate in the study, but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.

xii.Participation in any clinical study within 90 days before the first dose of investigational product.

xiii.Loss of >= 350mL blood within 90 days before the first dose of investigational product.

xiv.Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).

xv.Patient with coronavirus infection (COVID-19).

Study & Design

• Study Type: BA/BE
• Study Design: Not specified