Metastatic Gastric CancerPhase 1/2NCT01099527
A Trial of RAD001/Capecitabine in Refractory Gastric Cancer
A Phase 1/2 study testing Everolimus (RAD001) and Capecitabine in people with Metastatic Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Gastric Cancer
- What is being tested?
- Everolimus (RAD001) and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Dec 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically proven gastric cancer patients
- Adequate organ function as defined by the following criteria:
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Trial of RAD001/Capecitabine in Refractory Gastric Cancer
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.
- Conditions
- Metastatic Gastric Cancer
- Being tested
- Everolimus (RAD001), Capecitabine
- Keywords
- gastric cancer, refractory, metastatic
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus (RAD001)Drug
dose escalation of capecitabine, everolimus
CapecitabineDrug
dose escalation of capecitabine, everolimus
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Experimental | Everolimus (RAD001) dose escalation of capecitabine, everolimus
Capecitabine dose escalation of capecitabine, everolimus Receives: Drug: Everolimus (RAD001); Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine maximum tolerated dose (MTD) in phase I
Measured: 1 year
To assess response rate in phase II
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Gastric CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099527
- Sponsor's protocol ID
- 2009-02-041
- Status last verified
- Dec 2015
- First submitted
- 6 Apr 2010
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24013904
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of RAD001/Capecitabine in Refractory Gastric Cancer
- ClinicalTrials.gov ID
- NCT01099527
- Acronym / sponsor ID
- 2009-02-041
- Conditions
- Metastatic Gastric Cancer
- Keywords
- gastric cancer, refractory, metastatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Experimental | Drug: Everolimus (RAD001), Drug: CapecitabineEverolimus (RAD001) dose escalation of capecitabine, everolimus Capecitabine dose escalation of capecitabine, everolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically proven gastric cancer patients
- Adequate organ function as defined by the following criteria:
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus (RAD001)dose escalation of capecitabine, everolimus | Drug | Everolimus |
| Capecitabinedose escalation of capecitabine, everolimus | Drug | Everolimus |
Primary outcome
To determine maximum tolerated dose (MTD) in phase I
Time frame: 1 year
To assess response rate in phase II
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
- Derived from this study: PubMed 24013904Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Everolimus (RAD001) and Capecitabine in people with Metastatic Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine maximum tolerated dose (MTD) in phase I (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01099527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.