İleri Evre Solid Tümörü Olan Katılımcılarda Pamiparib (BGB-290) Etkililik, Güvenlilik ve Farmakokinetik Çalışması

Sade dilde özet

Bu çalışma, Pamiparib (BGB-290) adlı ilacın etkinliğini, güvenliğini ve vücuttaki davranışını (farmakokinetik) ileri evre solid tümörü (advanced solid tumors) olan hastalarda incelemiştir. Çalışmaya, üçlü negatif meme kanseri veya yüksek dereceli epitelyal yumurtalık kanseri gibi kanserleri olan, Faz 2 bölümünde ise germline BRCA1/2 mutasyonu taşıyan yetişkin hastalar katılmıştır. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Tamamlandı

Sponsor

BeiGene

Müdahale

Pamiparib

Başlangıç

21.12.2016

Tahmini bitiş

11.08.2021

Ülkeler

China

İlgili genler

Merkezler

• Beijing, China
• Beijing, China
• Zhengzhou, China
• Changsha, China
• Shanghai, China
• Hangzhou, China

Uygunluk kriterleri

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

Key Inclusion Criteria:

1. Participants have voluntarily agreed to participate by giving written informed consent.
2. Age 18 years (including 18 years) on the day of signing informed consent.
3. Participants meet the following eligibility criteria for the corresponding part of the study: 1) In Phase 1 portion: The participants must have a histologically or cytologically confirmed locally advanced or metastatic cancer, either triple-negative breast cancer or epithelial, non-mucinous, high-grade ovarian cancer (including fallopian cancer, or primary peritoneal cancer), for which no effective standard therapy is available.

2\) In Phase 2 portion: Participants who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline BRCA1/2 mutation 4. Participants must have measurable disease as defined per the RECIST, version 1.1.

5\. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Key Exclusion Criteria:

1. Participants who have been treated with chemotherapy, biologic therapy, immunotherapy, investigational agent, anti-cancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤5 half-lives, whichever is shorter) prior to starting study drug, or who have not adequately recovered from the side effects of such therapy.
2. Participants who have undergone major surgery for any cause ≤ 4 weeks prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
3. Participants who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
4. Untreated and/or active brain metastases.
5. Prior therapies targeting poly (ADP-ribose) polymerase (PARP).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.