A study to find inherited gene changes in certain cancers and to see how well PARP inhibitor treatment works in Indian patients.

Assessing the Frequency of Pathogenic Germline HRR Gene Mutations in Selected Solid Tumors Without Established Testing Guidelines and Exploring the Therapeutic Utility of PARP Inhibition in Indian Cohort : A Prospective Basket Study (GENPARPi study) - GENPARPi study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/111228

Enrollment

Registered

2026-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Olaparib 300 mg: Olaparib 300 mg orally twice daily as maintenance therapy following platinum response. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age greater than or equal to eighteen years. 2.Histologically confirmed: Advanced non small cell lung cancer. Recurrent or metastatic head and neck squamous cell carcinoma. Metastatic urothelial bladder cancer. 3.Patients with a family history of malignancy, defined as at least one first degree relative or at least two second degree relatives. 4.Eligible for and willing to undergo germline genetic testing for BRCA one, BRCA two, and PALB two. 5.Patients who have achieved disease control, including complete response, partial response, or stable disease, after platinum based chemotherapy. 6.Eastern Cooperative Oncology Group performance status acceptable for oral therapy. 7.Provided written informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients without a family history suggestive of hereditary cancer predisposition. 2.Patients not eligible for or unwilling to undergo genetic testing. 3.Patients with progressive disease after platinum based therapy. 4.Prior treatment with PARP inhibitors. 5.Patients with uncontrolled comorbid illness or poor performance status. 6.Pregnant or lactating women. 7.Patients unable to comply with study procedures.

Design outcomes

Primary

Measure	Time frame
To estimate the prevalence of pathogenic germline BRCA1, BRCA2, and PALB2 mutations in selected solid tumors. Timepoint: Baseline / Screening phase (prior to therapeutic enrollment and before Olaparib initiation)	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactAparna Sharma

National Cancer Institute, Aiims, Jhajjar

aparna96@gmail.com7895683095

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026