Yumurtalık ve Metastatik Meme Kanseri Olan Hindistanlı Hastalarda Olaparib'in Prospektif Çok Merkezli Faz IV Klinik Çalışması

Sade dilde özet

Bu çalışma, yumurtalık kanseri (ovarian cancer) veya metastatik meme kanseri (breast cancer) olan Hindistanlı hastalarda Olaparib adlı ilacın etkinliğini ve güvenliğini inceledi. Katılım için 18 yaş ve üzeri kadın hastalar aranıyordu; yumurtalık kanserinde platin bazlı kemoterapiye yanıt vermiş, meme kanserinde ise BRCA gen mutasyonu taşıyan hastalar dahil edildi. Çalışma Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 4 (Phase 4)

Durum

Tamamlandı

Sponsor

AstraZeneca

Müdahale

Olaparib

Başlangıç

25.05.2020

Tahmini bitiş

30.09.2022

Ülkeler

India

İlgili genler

Merkezler

• Ahmedabad, India
• Bhubaneswar, India
• Chandigarh, India
• Delhi, India
• Faridabad, India
• Guwahati, India
• Kochi, India
• Kolkata, India
• Kolkata, India
• Madurai, India
• Mumbai, India
• Mumbai, India
• New Delhi, India
• New Delhi, India
• New Delhi, India
• Vellore, India

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

1. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures..
2. Female Subjects with ≥ 18 years of age
3. Subjects receiving olaparib for the following indications in ovarian cancer:

   for the maintenance treatment of adult subjects with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
4. Subjects receiving olaparib for the following indication in breast cancer:

in subjects with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Subjects with HR-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment

Exclusion Criteria:

1. Patients with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
2. pregnant and/or lactating women.
3. Patients with a previously or currently diagnosed MDS/ AML or pneumonitis.
4. Patients who have not recovered sufficiently from prior surgery or anticancer treatment.
5. Patients who have known history of hepatitis B or hepatitis C
6. Patients with active infection such as TB.
7. Participation in another clinical study with a study drug administered in the last 3 months