Gastric Cancer.NCT02209441
Phase I Study of Sorafinib With Folfox4 as First-line Treatment in Advanced/Metastatic Gastric Cancer
A study testing Phase I Dose-finding Study of Sorafenib Study in people with Gastric Cancer., run by Chinese Academy of Medical Sciences.
Trial summary
To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as first-line treatment for advanced gastric cancer The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide elevation of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer.
- What is being tested?
- Phase I Dose-finding Study of Sorafenib Study
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- age >18 years.
- documented gastric adenocarcinoma via histological or cytological examinations;
- newly diagnosed or recurrent unresectable advanced and metastatic gastric cancer;
- no history of chemotherapy or radiation therapy; at least one lesion with a measurable diameter; -
- an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- an expected survival time of at least 3 months;
- and provision of informed consent by patients prior to commencement of the study.
Who cannot join
- a present or past medical history of other tumors, except for cured skin cancer (non-melanoma) or carcinoma in situ of the cervix;
- surgery, open biopsy, or obvious trauma within 28 days prior to enrolment; peritoneal seeding or intestinal obstruction;
- severe gastrointestinal bleeding; grade 1 or greater peripheral neuropathy
- a past medical history of serious neurological or psychiatric diseases; pregnancy or lactation;
- women of childbearing potential unwilling to use adequate contraception; a past medical history of heart disease such as greater than grade 2 New York Heart Association (NYHA) congestive heart failure, unstable coronary heart disease (patients having episodes of myocardial infarction earlier than 12 months prior to the study were allowed to enrol), arrhythmia requiring antiarrhythmic therapy (patients on β-blockers or digoxin were allowed to enrol), or uncontrolled hypertension; severe active infection
- epileptic patients requiring medical treatment (such as corticosteroids or antiepileptic drugs);
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- patients who had received immunotherapy within 4 weeks prior to or throughout the study or had received mitomycin C or nitrourea drugs within 4 weeks previously;
- allergies or possible allergies to the study medications or other drugs administered during the study;
- any patient safety or compliance issues that might jeopardize their participation in the study;
- an inability to swallow oral drugs.
Trial locations and contacts
No sites are listed yet.
About this study
- To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as first-line treatment for advanced gastric cancer
- The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide elevation of the sorafenib dosage to the next level
Read the detailed description
-Twice-daily dosing of sorafenib 200 mg in combination with FOLFOX4 proved effective and safe for the treatment of advanced gastric cancer.
- Conditions
- Gastric Cancer.
- Being tested
- Phase I Dose-finding Study of Sorafenib Study
- Keywords
- sorafenib, gastric cancer, FOLFOX4
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I Dose-finding Study of Sorafenib StudyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer.Studies of the same condition, open and under way.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Yuankai, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209441
- Sponsor's protocol ID
- BAY43
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Sorafinib With Folfox4 as First-line Treatment in Advanced/Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT02209441
- Acronym / sponsor ID
- BAY43
- Conditions
- Gastric Cancer.
- Keywords
- sorafenib, gastric cancer, FOLFOX4
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- First posted
- 6 Aug 2014 (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.
- To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as first-line treatment for advanced gastric cancer
- The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide elevation of the sorafenib dosage to the next level
Detailed description
-Twice-daily dosing of sorafenib 200 mg in combination with FOLFOX4 proved effective and safe for the treatment of advanced gastric cancer.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age >18 years.
- documented gastric adenocarcinoma via histological or cytological examinations;
- newly diagnosed or recurrent unresectable advanced and metastatic gastric cancer;
- no history of chemotherapy or radiation therapy; at least one lesion with a measurable diameter; -
- an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
Key exclusion criteria (10 listed)
- a present or past medical history of other tumors, except for cured skin cancer (non-melanoma) or carcinoma in situ of the cervix;
- surgery, open biopsy, or obvious trauma within 28 days prior to enrolment; peritoneal seeding or intestinal obstruction;
- severe gastrointestinal bleeding; grade 1 or greater peripheral neuropathy
- a past medical history of serious neurological or psychiatric diseases; pregnancy or lactation;
- women of childbearing potential unwilling to use adequate contraception; a past medical history of heart disease such as greater than grade 2 New York Heart Association (NYHA) congestive heart failure, unstable coronary heart disease (patients having episodes of myocardial infarction earlier than 12 months prior to the study were allowed to enrol), arrhythmia requiring antiarrhythmic therapy (patients on β-blockers or digoxin were allowed to enrol), or uncontrolled hypertension; severe active infection
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 |
|---|---|---|
| Phase I Dose-finding Study of Sorafenib Study | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Phase I Dose-finding Study of Sorafenib Study in people with Gastric Cancer., run by Chinese Academy of Medical Sciences.
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 7 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: status not confirmed, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yihebali Chi, Doctor (+86 13911075626, yihebalichi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 6 Aug 2014.