Gastrointestinal CancersGITICNCT02013089
A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers, GITIC Study
A study testing Erlotinib or Gefitinib, Everolimus and Imatinib in people with Gastrointestinal Cancers, run by Sun Yat-sen University at 1 site in China.
Trial summary
Hypothesis: Different patients have different biomarkers, if doctors know about the biomarkers of patients; they may be able to prescribe a regimen that is better suited to the patient's specific needs. This is a pilot study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Cancers
- What is being tested?
- Erlotinib or Gefitinib, Everolimus and Imatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Dec 2017
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic diagnosis of Gastrointestinal cancer
- The subject has a diagnosis metastatic gastrointestinal cancer, and failed from standard treatment, and no other regimen is available.
- The subject has measurable lesion of gastrointestinal cancer.
- The subject's The Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- The subject has adequate hematologic function as defined by an absolute neutrophil count (ANC) >/= 1,500/mm3, platelet count >/= 100,000/mm3, White Blood Count (WBC) >/= 3,000/ mm3, and hemoglobin >/= 9 g/dL.
- The subject has adequate hepatic function as defined by a total bilirubin level </= 1.5 * the upper limit of normal (ULN) (bilirubin >/= 1.5 * ULN with known Gilbert's disease is allowed), and alkaline phosphatase, aspartate aminotransferase/alanine aminotransferase (AST/ALT) </= 2.5 * the upper limit of normal or </= 5.0 * ULN if liver metastases are present.
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- Serum creatinine clearance >50ml/min, either by Cockcroft-Gault formula or 24-hour urine collection analysis
- The subject is >/=18 years of age.
- The subject has signed informed consent.
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation, hysterectomy or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.
Who cannot join
- pregnant or breast-feeding.
- Subjects will be excluded for other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
- without enough tumor sample for analysis.
- Refuse to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Yanghong Deng, PhD, 008613925106525, 13925106525@163.com
Yanhong Deng, PhD
About this study
Official title: A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers
Hypothesis: Different patients have different biomarkers, if doctors know about the biomarkers of patients; they may be able to prescribe a regimen that is better suited to the patient's specific needs. This is a pilot study. Here, we used whole exon sequencing and Integrated genomic network analysis to identify the biomarker or gene. We aimed to learn if the drug chosen based on biomarkers can help to control metastatic gastrointestinal cancer who had failed from all standard and available regimens.
Read the detailed description
Rational: Cancer sequencing (CS) promises to become the centerpiece of personalized oncology by informing on treatments targeted to each tumor's unique genetic constitution. This data can be critical to making an informed decision for disease management, though this may not be the case for all patients. CS identifies variations or differences in the DNA and/or RNA of the cells in an individual's tumor by comparison to that of his/her normal cells. These somatic variations may, on further interpretation, be identified as key drivers of carcinogenesis. Such information may predict a patient's prognosis, response to currently available treatments or prompt the development of novel therapeutics. Though CS has the potential to personalize and optimize cancer care, it may produce a vast amount of data and unique changes in the DNA/RNA that may be difficult to interpret at the present time.
Using the Integrated genomic network analysis, we could have better understanding of the underlying processes and pathways involved in tumor onset and progression. And then we could choose a specific treatment regimen and develop personalized cancer therapies
- Conditions
- Gastrointestinal Cancers
- Being tested
- Erlotinib or Gefitinib, Everolimus, Imatinib, Sorafenib or Sunitinib, Vandetanib
- Keywords
- genomic sequencing, Integrated genomic network analysis
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib or GefitinibDrug
Also called Erlotinib (Tarceva®) or Gefitinib (Iressa®)
Erlotinib 150mg talbet or Gefitinib 250 mg tablet per day for patients with EGFR gene alternation
EverolimusDrug
Also called Afinitor®
Everolimus 10 mg orally once daily every day for patients with mTOR gene alternation
ImatinibDrug
Also called Gleevec®
Imatinib 400 mg tablet orally per day for patietns with KIT, PDGFR, ABL gene alternation
Sorafenib or SunitinibDrug
Also called Sorafenib (Nexavar®) Sunitinib (Sutent®)
Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day with or without food for patients with VEGFR, KIT, RAF gene alternation
VandetanibDrug
Also called Caprelsa®
Vandetanib 300 mg orally once daily for patients with RET gene fusion.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib or Gefitinib | Experimental | Erlotinib 150 mg tablet or Gefitinib 250 mg tablet by mouth every day Receives: Drug: Erlotinib or Gefitinib |
| Everolimus | Experimental | Everolimus 10 mg orally once daily every day Receives: Drug: Everolimus |
| Imatinib | Experimental | Imatinib 400 mg tablet orally per day Receives: Drug: Imatinib |
| Sorafenib or Sunitinib | Experimental | Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day Receives: Drug: Sorafenib or Sunitinib |
| Vandetanib | Experimental | Vandetanib 300 mg orally once daily Receives: Drug: Vandetanib |
| Control | No intervention | No intervention was performed for patients without any gene alternation or without any available target agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
From the date of enrollment until the date of death from any cause.
Measured: 1 year
Secondary outcomes (1)
Response rate
After identifying the driver gene and choosing the specific target drug, the response rate of all patients.
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 posted17 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancersStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Yanghong Deng, PhD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013089
- Sponsor's protocol ID
- GIHSYSU04
- Acronym
- GITIC
- Status last verified
- Aug 2016
- First submitted
- 11 Dec 2013
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT02013089
- Acronym / sponsor ID
- GITIC / GIHSYSU04
- Conditions
- Gastrointestinal Cancers
- Keywords
- genomic sequencing, Integrated genomic network analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Dec 2013 (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.
Hypothesis: Different patients have different biomarkers, if doctors know about the biomarkers of patients; they may be able to prescribe a regimen that is better suited to the patient's specific needs. This is a pilot study. Here, we used whole exon sequencing and Integrated genomic network analysis to identify the biomarker or gene. We aimed to learn if the drug chosen based on biomarkers can help to control metastatic gastrointestinal cancer who had failed from all standard and available regimens.
Detailed description
Rational: Cancer sequencing (CS) promises to become the centerpiece of personalized oncology by informing on treatments targeted to each tumor's unique genetic constitution. This data can be critical to making an informed decision for disease management, though this may not be the case for all patients. CS identifies variations or differences in the DNA and/or RNA of the cells in an individual's tumor by comparison to that of his/her normal cells. These somatic variations may, on further interpretation, be identified as key drivers of carcinogenesis. Such information may predict a patient's prognosis, response to currently available treatments or prompt the development of novel therapeutics. Though CS has the potential to personalize and optimize cancer care, it may produce a vast amount of data and unique changes in the DNA/RNA that may be difficult to interpret at the present time.
Using the Integrated genomic network analysis, we could have better understanding of the underlying processes and pathways involved in tumor onset and progression. And then we could choose a specific treatment regimen and develop personalized cancer therapies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Erlotinib or Gefitinib | Experimental | Drug: Erlotinib or GefitinibErlotinib 150 mg tablet or Gefitinib 250 mg tablet by mouth every day |
| Everolimus | Experimental | Drug: EverolimusEverolimus 10 mg orally once daily every day |
| Imatinib | Experimental | Drug: ImatinibImatinib 400 mg tablet orally per day |
| Sorafenib or Sunitinib | Experimental | Drug: Sorafenib or SunitinibSorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day |
| Vandetanib | Experimental | Drug: VandetanibVandetanib 300 mg orally once daily |
| Control | No intervention | –No intervention was performed for patients without any gene alternation or without any available target agents |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologic diagnosis of Gastrointestinal cancer
- The subject has a diagnosis metastatic gastrointestinal cancer, and failed from standard treatment, and no other regimen is available.
- The subject has measurable lesion of gastrointestinal cancer.
- The subject's The Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- The subject has adequate hematologic function as defined by an absolute neutrophil count (ANC) >/= 1,500/mm3, platelet count >/= 100,000/mm3, White Blood Count (WBC) >/= 3,000/ mm3, and hemoglobin >/= 9 g/dL.
Key exclusion criteria (4 listed)
- pregnant or breast-feeding.
- Subjects will be excluded for other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
- without enough tumor sample for analysis.
- Refuse to sign the informed consent.
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 |
|---|---|---|
| Erlotinib or GefitinibAlso: Erlotinib (Tarceva®) or Gefitinib (Iressa®)Erlotinib 150mg talbet or Gefitinib 250 mg tablet per day for patients with EGFR gene alternation | Drug | Erlotinib or Gefitinib |
| EverolimusAlso: Afinitor®Everolimus 10 mg orally once daily every day for patients with mTOR gene alternation | Drug | Everolimus |
| ImatinibAlso: Gleevec®Imatinib 400 mg tablet orally per day for patietns with KIT, PDGFR, ABL gene alternation | Drug | Imatinib |
| Sorafenib or SunitinibAlso: Sorafenib (Nexavar®) Sunitinib (Sutent®)Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day with or without food for patients with VEGFR, KIT, RAF gene alternation | Drug | Sorafenib or Sunitinib |
| VandetanibAlso: Caprelsa®Vandetanib 300 mg orally once daily for patients with RET gene fusion. | Drug | Vandetanib |
Primary outcome
Overall survival
Time frame: 1 year
From the date of enrollment until the date of death from any cause.
1 secondary outcome
Response rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
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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.
Yanghong Deng, PhD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erlotinib or Gefitinib, Everolimus and Imatinib in people with Gastrointestinal Cancers, run by Sun Yat-sen University at 1 site in China.
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 4 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 30 Aug 2016. 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 China. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1 year). 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 30 Aug 2016.