NCT01099527

Brief Summary

Capecitabine is an oral fluoropyrimidine that has been shown to be effective in the treatment of metastatic gastric and colorectal cancer patients. On the basis of capecitabine-based chemotherapy which is accepted as a standard regimen in gastric cancer, we will perform the phase I/II study with all-oral regimen of RAD001 with capecitabine for these refractory gastric cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

3.8 years

First QC Date

April 6, 2010

Last Update Submit

December 28, 2015

Conditions

Metastatic Gastric Cancer

Keywords

gastric cancerrefractorymetastatic

Outcome Measures

Primary Outcomes (2)

  • To determine maximum tolerated dose (MTD) in phase I

    1 year

  • To assess response rate in phase II

    1 year

Study Arms (1)

Everolimus

EXPERIMENTAL

Everolimus (RAD001) dose escalation of capecitabine, everolimus Capecitabine dose escalation of capecitabine, everolimus

Drug: Everolimus (RAD001)Drug: Capecitabine

Interventions

Everolimus (RAD001)DRUG

dose escalation of capecitabine, everolimus

Everolimus
CapecitabineDRUG

dose escalation of capecitabine, everolimus

Everolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically proven gastric cancer patients
  • Adequate organ function as defined by the following criteria:
  • A. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B. Total serum bilirubin ≤ 3.0 mg/dL C. Absolute neutrophil count (ANC) ≥1500/µL D. Platelets ≥100,000/µL E. Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F. Serum calcium ≤12.0 mg/dL G. Serum creatinine ≤1.5 x ULN
  • Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
  • Patients who have failed to at least two previous cytotoxic chemotherapy for advanced gastric cancer (adjuvant treatment will be counted as one regimen if received \< 12 months from the start of experimental treatment)
  • At least one measurable lesion by RECIST criteria
  • ECOG PS 0-2
  • Patients with informed consent

You may not qualify if:

  • Major surgery or radiation therapy within 4 weeks of starting the study treatment.
  • History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
  • Pregnancy or breastfeeding.
  • Prior exposure to the study drug.
  • Patients unable to swallow oral medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Cancer Center

Seoul, South Korea

Location

Related Publications (1)

  • Lee SJ, Lee J, Lee J, Park SH, Park JO, Park YS, Lim HY, Kim KM, Do IG, Jung SH, Yim DS, Kang WK. Phase II trial of capecitabine and everolimus (RAD001) combination in refractory gastric cancer patients. Invest New Drugs. 2013 Dec;31(6):1580-6. doi: 10.1007/s10637-013-0022-0. Epub 2013 Sep 7.

    PMID: 24013904DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Interventions

EverolimusCapecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Samsung Medical center

Study Record Dates

First Submitted

April 6, 2010

First Posted

April 7, 2010

Study Start

October 1, 2009

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

KR(1)