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

Solid Tumor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449538
• Other study ID #: 2015-01-117
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2015
• Last updated: February 16, 2017
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: February 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Provision of fully informed consent prior to any study specific procedures.

2. Patients must be =20 years of age.

3. 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.

4. ECOG performance status 0-2.

5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.

6. 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

7. 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.

8. Adequate heart function.

Exclusion Criteria:

1. 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.

2. Has known active central nervous system (CNS) metastases.

3. Has an active infection requiring systemic therapy.

4. Pregnancy or breast feeding

5. Patients with cardiac problem.

6. KRAS mutation (codon 12 or 13) or BRAF mutation (V600)

7. Any previous treatment with everolimus

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• everolimus
everolimus 10 mg qd daily one cycle is 28days.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate		24 weeks
Secondary	progression free survival		24 weeks
Secondary	overall survival		24 weeks
Secondary	Number of subjects with Adverse Events as a measure of toxicity profile		24 weeks