Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors

NCT02449538 | Completed Phase 2

• 1 other identifier: 2015-01-117
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA mutation and PIK3CA amplification Refractory Solid Tumors . Everolimus 10 mg will be administered orally qd daily. To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA mutantion and PIK3CA amplification Refractory Solid Tumors.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• overall response rate

  24 weeks

Secondary Outcomes (3)

• progression free survival

  24 weeks

• overall survival

  24 weeks

• Number of subjects with Adverse Events as a measure of toxicity profile

  24 weeks

Study Arms (1)

everolimus

EXPERIMENTAL

everolimus 10 mg qd daily

Drug: everolimus

Interventions

everolimus DRUG

everolimus 10 mg qd daily one cycle is 28days.

Also known as: RAD001

everolimus

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of fully informed consent prior to any study specific procedures.
• Patients must be ≥20 years of age.
• PIK3CA amplification, PTEN loss and PIK3CA mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
• ECOG performance status 0-2.
• Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
• Adequate Organ Function Laboratory Values
• Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 75 x 109/L
• bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
• creatinine ≤1.5 x UNL
• Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
• Adequate heart function.

You may not qualify if:

• Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
• Has known active central nervous system (CNS) metastases.
• Has an active infection requiring systemic therapy.
• Pregnancy or breast feeding
• Patients with cardiac problem.
• KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
• Any previous treatment with everolimus

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• Kim ST, Lee J, Park SH, Park JO, Park YS, Kang WK, Lim HY. Prospective phase II trial of everolimus in PIK3CA amplification/mutation and/or PTEN loss patients with advanced solid tumors refractory to standard therapy. BMC Cancer. 2017 Mar 23;17(1):211. doi: 10.1186/s12885-017-3196-6.

  PMID: 28330462 DERIVED

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Jee yun Lee, MD,Ph.D.

  Samsung Medical Center,Seoul,Korea

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 20, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

KR (1)