Health Condition 1: C169- Malignant neoplasm of stomach, unspecified
Conditions
Interventions
Intervention1: Olaparib: Olaparib 300 mg PO twice daily, till disease progression, significant grade 3/4 toxicity, patient
choice or a maximum of 12 months. Treatment beyond 12 months (in case of main
till disease
progression, significant grade 3/4 toxicity, patient choice or a maximum of 12 months. Treatment beyond 12
months (in case of maintained response or stable disease) will be as per investi
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Cancer specific 1. Patients having a confirmed diagnosis of advanced gastric adenocarcinoma 2. Has received FOLFOX/CAPOX/SOX/DOX/FLOT/DCF for at least 6 months without clinical disease progression 3. Has documented HRD positivity or BRCA positivity General 1. The patient understands the nature and purpose of this study and the study procedures and has signed informed consent. 2. The patient is aged more than 18 years. 3. Patients should be chemotherapy naïve. 4. The patient has a WHO Performance Status of less than equals to 2. 5. Hematologic and metabolic status must be adequate for receiving planned chemotherapy, and meet the following criteria: 6. Total neutrophils greater than equal to 1500/mm3, Platelets greater than equals to 100,000/mm3, Bilirubin less than equals to 1.5 x ULN (Upper Limits of Normal), Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)less than equals to 3 x ULN, GFR greater than equals to 50 ml/min 7. The patient / the attendant is able to read, understand, and complete questionnaires and daily components of the Patient Diary for each study cycle. 8. For patients of childbearing potential, urine human chorionic gonadotropin (hCG) (urine dipstick pregnancy test) or blood hCG results must be negative at screening 9. Has a normal baseline ECG with no QTc prolongation
Exclusion criteria
Exclusion criteria: The patient and/ or attendant are unable to read, understand, and complete the forms required for the study. The patient is pregnant or lactating. The patient has a history of active peptic ulcer disease, significant or symptomatic, acute or subacute gastrointestinal obstruction, increased intracranial pressure, severe cognitive impairment, known central nervous system disease (e.g. brain metastases/ a seizure disorder). Uncontrolled medical comorbidities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to compare capecitabine (standard arm) Olaparib (experimental arm) with respect to progression free survival (PFS) in BRCA or HRD positive advanced gastric cancers.Timepoint: The primary objective is to compare capecitabine (standard arm) Olaparib (experimental arm) with respect to progression free survival (PFS) in BRCA or HRD positive advanced gastric cancers. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare capecitabine (standard arm) Olaparib (experimental arm) with respect to overall survival (OS) in BRCA or HRD positive advanced gastric cancers.Timepoint: OS is measured from the date of randomization to the date of death, or last observation if lost to follow-up or alive at study close-out.;To compare quality of lifeTimepoint: Quality of life is assessed using the EORTC QLQ-C30 questionnaire: At baseline (before starting study treatment) At approximately 3 months post-starting therapy At approximately 6 months post-starting therapy;To compare tolerance and side effects with both drugsTimepoint: At every visit, with adverse events recorded and graded according to NCI CTCAE v5.0 Assessments repeat every 3 months or whenever clinically indicated until disease progression, withdrawal, or end of treatment | — |
Countries
India
Contacts
Public ContactDr Anant Ramaswamy
Tata Memorial Hospital
Outcome results
None listed