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A Trial of RAD001/Capecitabine in Refractory Gastric Cancer

NCT ID: NCT01099527

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Gastric Cancer

Keywords

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gastric cancer refractory metastatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Everolimus

Everolimus (RAD001) dose escalation of capecitabine, everolimus

Capecitabine dose escalation of capecitabine, everolimus

Group Type EXPERIMENTAL

Everolimus (RAD001)

Intervention Type DRUG

dose escalation of capecitabine, everolimus

Capecitabine

Intervention Type DRUG

dose escalation of capecitabine, everolimus

Interventions

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Everolimus (RAD001)

dose escalation of capecitabine, everolimus

Intervention Type DRUG

Capecitabine

dose escalation of capecitabine, everolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Histologically or cytologically proven gastric cancer patients
2. 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
3. Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
4. 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)
5. At least one measurable lesion by RECIST criteria
6. ECOG PS 0-2
7. Patients with informed consent

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeeyun Lee

Samsung Medical center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Cancer Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 24013904 (View on PubMed)

Other Identifiers

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2009-02-041

Identifier Type: -

Identifier Source: org_study_id