Advanced Gastric CancerPhase 1/2NCT00565370
Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC): Sorafenib+XP
A Phase 1/2 study testing Capecitabine, Cisplatin, Sorafenib in people with Advanced Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Capecitabine, Cisplatin, Sorafenib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to Dec 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having given signed written informed consent
- Unresectable advanced gastric adenocarcinoma, initially diagnosed or recurred
- No history of chemotherapy or radiation
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Age 18-75 years
- Estimated life expectancy of more than 3 months
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow function (absolute neutrophil count > 1,500/µL, platelets > 100,000/µL, hemoglobin > 8g/dl),
- Adequate kidney function (creatinine clearance > 60 ml/min)
- Adequate liver function (bilirubin < 2.0 mg/dL, transaminases levels < 3 times the upper normal limit [5 times for patients with liver metastasis])
Who cannot join
- Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
- Presence of central nervous system metastasis
- Obvious peritoneal seeding or bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Event version 3.0 > Grade I)
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- History of significant neurologic or psychiatric disorders
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
- Known allergy to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer
There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.
- Conditions
- Advanced Gastric Cancer
- Being tested
- Capecitabine, Cisplatin, Sorafenib
- Keywords
- Gastric cancer, capecitabine, cisplatin, sorafenib, phase I, phase II
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine, Cisplatin, SorafenibDrug
Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | XP+sorafenib Receives: Drug: Capecitabine, Cisplatin, Sorafenib |
| B | Placebo comparator | XP Receives: Drug: Capecitabine, Cisplatin, Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
Measured: 28weeks
Progression-free Survival
Measured: 1 year
Secondary outcomes (3)
Response Rate
Tumor response was assessed every two cycles by RECIST(v1.0) using the same imaging techniques and methods used at baseline.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate
Measured: 6 months
Overall Survival
Measured: 28 months
Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)
Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib
Measured: 28weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Asan 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoon-Koo Kang, Asan Medical Center
- Investigators
- Yoon-Koo Kang, MD, PhD, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565370
- Sponsor's protocol ID
- AMC0701
- Status last verified
- Jan 2020
- First submitted
- 28 Nov 2007
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00565370
- Acronym / sponsor ID
- AMC0701
- Conditions
- Advanced Gastric Cancer
- Keywords
- Gastric cancer, capecitabine, cisplatin, sorafenib, phase I, phase II
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Nov 2007 (estimated)
- Results
- Posted 31 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Capecitabine, Cisplatin, SorafenibXP+sorafenib |
| B | Placebo comparator | Drug: Capecitabine, Cisplatin, SorafenibXP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Having given signed written informed consent
- Unresectable advanced gastric adenocarcinoma, initially diagnosed or recurred
- No history of chemotherapy or radiation
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Age 18-75 years
Key exclusion criteria (10 listed)
- Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
- Presence of central nervous system metastasis
- Obvious peritoneal seeding or bowel obstruction
- Evidence of serious gastrointestinal bleeding
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 |
|---|---|---|
| Capecitabine, Cisplatin, SorafenibCapecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks | Drug | A, B |
Primary outcome
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
Time frame: 28weeks
Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
Progression-free Survival
Time frame: 1 year
3 secondary outcomes
Response Rate
Time frame: 6 months
Overall Survival
Time frame: 28 months
Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)
Time frame: 28weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yoon-Koo Kang, MD, PhD study chair
Asan Medical Center
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 Capecitabine, Cisplatin, Sorafenib in people with Advanced Gastric Cancer, run by Asan 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 10 inclusion and 10 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 18 Jan 2020. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) (time frame: 28weeks). 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?
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 18 Jan 2020.