Phase II Trial of Vistusertib（AZD2014） Single Agent in TSC1or 2 Null or TSC 1/2 Mutation Solid Cancer Patients Refractory to Standard Chemotherapy

NCT03166176 | Withdrawn Phase 2

• 1 other identifier: 2017-05-096
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with TSC1/2 mutated refractory solid cancer will receive vistusertib(AZD2014) monotherapy. Study-arm is composed of 27 patients. Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle as a monotherapy

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Objective reponse rate (ORR) by RECIST 1.1

  To investigate the efficacy and safety of vistusertib(AZD2014) single agent as salvage therapy in patients with TSC1or 2 null or TSC 1/2

  12months

Interventions

Vistusertib(AZD2014) DRUG

vistusertib(AZD2014) is selective inhibitor of mTOR kinases and inhibits signalling of both mTOR complexes, mTORC1 and mTORC2.

Also known as: AZD2014

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Provision of tumor sample (from either a resection or biopsy)
• Patients with TSC1or 2 null or TSC 1/2 mutation through IHC.
• Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
• Haemoglobin ≥9.0 g/dL (transfusion allowed)
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• White blood cells (WBC) \> 3 x 109/L
• Platelet count ≥100 x 109/L (transfusion allowed)
• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
• AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
• Serum creatinine ≤1.5 x institutional ULN

You may not qualify if:

• Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity.
• For vistusertib(AZD2014):
• Exposure to potent or moderate inhibitors or inducers of CYP3A4/5 if taken within the stated washout periods before the first dose of study treatment With the exception of alopecia, any ongoing toxicities (\>CTCAE grade 1) caused by previous cancer therapy.
• Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

vistusertib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Model Details: Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 25, 2017
• Study Start: March 1, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

KR (1)