Solid Tumor Clinical Trial
— RICTOR_SCOfficial title:
AZD2014 in RICTOR Amplified Solid Cancer
Verified date | May 2019 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014).
Study-arm is composed of 27 patients.
Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle Tumour evaluation using
RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8
weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective
disease progression (within a window of +/- 7 days of the scheduled date).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 31, 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Advanced solid cancers (including histologically or cytologically documented gastric cancer, colorectal cancer, hepatoma, biliary tract cancers, pancreatic cancer and rare cancers.) that has progressed after standard chemotherapy. - Rare cancers are defined as sarcoma, neuroendocrine carcinoma 2. Provision of tumor sample tumor sample tumor sample tumor sampletumor sample (from either a resection or biopsy) 3. Patients with RICTOR amplification through NGS. 4. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. Exclusion Criteria: 1. Patients not having received recommended treatment-lines and chemotherapy regimen for the treatment of each tumor type in the advanced setting. 2. Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity. 3. HER2 positive AGC patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective reponse rate (ORR) by RECIST 1.1 | 12months |
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