ROSY-T: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Osimertinib (TAGRISSO) and are Judged by the Investigator to Clinically Benefit From Continued Treatment - D5161N00007

Astrazeneca AB0 个研究点目标入组 43 人开始时间: 2023年4月21日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Astrazeneca AB
入组人数: 43

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Provision of signed and dated, written ICF., Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment with osimertinib (TAGRISSO) in an AstraZeneca parent study using osimertinib (TAGRISSO) monotherapy, which has met its endpoints or has otherwise stopped., Females should be using adequate contraceptive measures if of childbearing potential. Male patients should be willing to use barrier contraception, ie, condoms.

排除标准

•Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study., Currently receiving treatment with any prohibited medication(s)., Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study., Permanent discontinuation from the parent study due to toxicity or disease progression., Local access to commercially-available drug at no cost to the patient is permitted by local regulation. Note: In countries where, according to local requirements, it is not possible to switch patients to the commercial drug through prescription, even if fully reimbursed, patients are eligible to participate in the ROSY-T sub-study., Active infection (eg, patients receiving treatment for infection) including active hepatitis C and HIV infection or active uncontrolled HBV infection. Screening for chronic conditions is not required. Patients with HBV infection are only eligible if they meet all the following criteria: - Demonstrated absence of HCV co-infection or history of HCV co-infection; - Demonstrated absence of HIV infection; - Patients receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to < 100 IU/mL, and transaminase levels are below ULN. Patients with a resolved or chronic HBV infection are eligible if they are: - Negative for HBsAg and positive for anti-HBc IgG. In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment and 6 to 12 months (to be determined by hepatologist) post treatment; or - Positive for HBsAg, but for > 6 months have had transaminases levels below ULN and HBV DNA levels below < 100 IU/mL (ie, patients are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2 to 4 weeks prior to study treatment and 6 to 12 months (to be determined by hepatologist) post treatment.

研究者

发起方

Astrazeneca AB

相似试验

招募中

1 期

Roll Over Study for Patients Who Have Completed a Previous OncologyStudy with DurvalumabPost-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract.First-line patients with extensive disease (Stage IV) small-cell lung cancer (SCLC).Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) in treatment naive patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type tumor pathology.Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III)Various types of cancer ( dependent on parent study)MedDRA version: 21.1Level: PTClassification code 10061272Term: Malignant urinary tract neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2021-003031-29-ESAstraZeneca AB175

尚未招募

3 期

Roll Over StudY for Patients Who Have Completed & Benefitted from a Previous Oncology Study With Durvalumab (ROSY-D)

CTRI/2024/01/061411AstraZeneca AB

进行中（未招募）

1 期

Roll Over Study for Patients Who Have Completed a Previous OncologyStudy with DurvalumabPost-Chemotherapy Urothelial and Non-Urothelial Carcinoma of theUrinary Tract. First-line patients with extensive disease (Stage IV) small-cell lung cancer (SCLC).Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) intreatment naive patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type tumour pathology. Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Various types of cancer ( dependent on parent study)MedDRA version: 21.1Level: PTClassification code 10061272Term: Malignant urinary tract neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2021-003031-29-DEAstraZeneca AB175

进行中（未招募）

1 期

Roll Over Study for Patients Who Have Completed a Previous Oncology Study with OlaparibBRCA Mutated Ovarian Cancer Patients, Epithelian ovarian cancer, Metastatic Breast Cancer, Platinum Sensitive Relapsed Ovarian CancerMedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2019-003777-26-FIAstraZeneca AB204

进行中（未招募）

1 期

Roll Over Study for Patients Who Have Completed a Previous Oncology Study with OlaparibBRCA Mutated Ovarian Cancer Patients, Epithelian ovarian cancer, Metastatic Breast Cancer, Platinum Sensitive Relapsed Ovarian Cancer, Patients with gBRCA mutated metastatic pancreatic cancerMedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10014733Term: Endometrial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2019-003777-26-SEAstraZeneca AB204