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Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02688881
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center

Brief Summary:

This study is a single arm, pilot study of sirolimus in patient with Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.

sirolimus 1mg will be administered orally daily. To investigate the efficacy and safety of sirolimus in patient with Refractory solid tumor.


Condition or disease Intervention/treatment Phase
Refractory Solid Tumors Drug: sirolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors
Actual Study Start Date : February 5, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: sirolimus
sirolimus 1mg will be administered orally daily
Drug: sirolimus
Rapamune




Primary Outcome Measures :
  1. Progression Free survival [ Time Frame: 6 Weeks ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 24 months ]
  2. Time to progression [ Time Frame: 24 months ]
  3. Overall survival [ Time Frame: 24 months ]
  4. Number of subjects with Adverse Events as a measure of safety [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of fully informed consent prior to study specific procedures.
  • Patients must be >= 19 years of age
  • Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration( H1047R, E542K, E545K, PTEN LOSS) Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  • ECOG Performance status0-2
  • Have measurable or evaluated disease based on RECIST 1.1 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 subject with liver metastases) Creatinine<= 1.5 X UNL
  • Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
  • Adequate heart function

Exclusion Criteria:

  • Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor 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
  • Any previous treatment with sirolimus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688881


Contacts
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Contact: Jeeyun Lee, MD,Ph.D. 2-3410-3459 ext 82 jyun.lee@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 99999
Contact: Jeeyun Lee, MD    +82-10-9933-1779    jyun.lee@samsung.com   
Sub-Investigator: Jeeyun Lee, Professor         
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Jeeyun Lee, MD,PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02688881    
Other Study ID Numbers: 2016-02-052
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Neoplasms
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs