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).
Withdrawn
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Vistusertib(AZD2014) | azd2014 | AZD2014 |
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).
Study treatment will be continued until objective disease progression (unless other criteria
for treatment discontinuation are met). Patients may continue vistusertib(AZD2014) beyond
progression (according to RECIST 1.1), at the discretion of the investigator if they are
clinically benefiting from the treatment and they do not meet any other discontinuation
criteria.
If a patient discontinues study treatment prior to disease progression, they should continue
to be assessed using RECIST 1.1 until disease progression and then followed up for survival.
Assessments for survival should be made every 8 weeks following objective disease
progression. The details of first and subsequent therapies for cancer, after discontinuation
of treatment, will be collected.
| Name | Type | Description | Interventions |
|---|---|---|---|
| AZD2014 | Experimental | Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle |
|
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 +)
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Objective reponse rate (ORR) by RECIST 1.1 |
| Time Frame: | 12months |
| Safety Issue: | |
| Description: |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Withdrawn |
| Lead Sponsor: | Samsung Medical Center |
May 20, 2019
