Colorectal CancerPhase 1NCT02720926
Study of TKI 258 in Combination With Xeloda and Oxaliplatin in Advanced Colorectal and Gastric Cancer
A Phase 1 study testing Xeloda,, Oxaliplatin and TKI258 in people with Colorectal Cancer and Gastric Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
Standard "3+3" dose escalation design of TKI258/XELOX in advanced gastric/gastro-oesophageal and colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Gastric Cancer
- What is being tested?
- Xeloda,, Oxaliplatin and TKI258
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2011to Jan 2012
- Phase
- Phase 1
- 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
- Patients must have histologically confirmed gastric, gastro-oesophageal or colorectal adenocarcinoma.
- The gastric or gastro-oesophageal cancer must be locally advanced unresectable or metastatic. Colorectal cancer must be metastatic and for which subsequent resection of all metastatic disease is assessed not to be feasible.
- Age >18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%, see Appendix A).
- Life expectancy of greater than 3 months
- Patients must have normal organ and marrow function as defined below:
Show all 16Show fewer
- leukocytes >3,000/mcL
- absolute neutrophil count >1,500/microliter (mcL) TKI258/XELOX phase 1 protocol version 3.3 Dated 30 November 2011 1 3
- platelets >100,000/mcL
- total bilirubin <= 1.5 x upper limit of normal (ULN)
- aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance >55 mL/min for patients with creatinine levels above institutional normal.
- The effects of TKI258 and XELOX on the developing human fetus are unknown. For this reason, women of child-bearing potential and men 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Baseline left ventricular ejection fraction (LVEF) >= 50%
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients are not considered to have a "currently active" malignancy if they have TKI258/XELOX phase 1 protocol version 3.3 Dated 30 November 2011 1 4 completed therapy and are considered to have a less than 30% risk of relapse.
- Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TKI258 or XELOX, breastfeeding should be discontinued if the mother is treated with TKI258 or XELOX.
- Patients with prior history of transient ischemia attack or cerebrovascular disease or prior history of ischemia heart disease or myocardia infarction and 2 or more risk factors: ever smoker with > 30 packs per year exposure or on medication for diabetes mellitus or hypertension or hyperlipidemia.
- In addition for the Beginning at dose expansion cohort, the following exclusion criteria apply:
- Patients who are not agreeable for collection of tumor tissue for correlative studies
- Patients from whom tumor tissue for correlative studies cannot be safely obtained.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of TKI 258 in Combination With Xeloda and Oxaliplatin in Upfront Treatment of Advanced Colorectal and Gastric Cancer With a Dose Expansion Cohort in Advanced Gastric Cancer
Standard "3+3" dose escalation design of TKI258/XELOX in advanced gastric/gastro-oesophageal and colorectal cancer.
Read the detailed description
This is a "3+3" dose escalation design with 4 pre-defined TKI258 dose levels (200mg, 300mg, 400mg and 500mg daily with 5 days on and 2 days off schedule) in combination with a fixed standard dose of XELOX (Capecitabine and Oxaliplatin) to establish the recommended phase 2 dose.
- Conditions
- Colorectal Cancer, Gastric Cancer
- Being tested
- Xeloda,, Oxaliplatin, TKI258
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeloda,Drug
Also called capecitabine
Capecitabine (xeloda): 2000mg/m2, twice a day on Day 1-14;
OxaliplatinDrug
Oxaliplatin: 130mg/m2 day 1 every 21days
TKI258Drug
4 dose levels of TKI258: 200mg, 300mg, 400mg, 500mg once daily, 5days on and 2 days off;
| Study group | Role | What they receive |
|---|---|---|
| TKI258 combined with Xeloda/Oxaliplatin | Experimental | TKI258 200 mg once a day (OD) 5 days on/2 days off Capecitabine (Xeloda) 2000 mg/m2 bid d1-14 Oxaliplatin 130mg/m2 d1 q21days Receives: Drug: Xeloda,; Drug: Oxaliplatin; Drug: TKI258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the recommended phase 2 dose of TKI258 in combination with XELOX (Capecitabine and Oxaliplatin)
Measured: 42 days
Secondary outcomes (2)
Describe the toxic effects of TKI258 when administered in combination with XELOX chemotherapy.
Toxicity will be graded using CTCAE version 4.0
Measured: one year
Measure the Area under the plasma concentration versus time curve (AUC) of TKI258 at specific timepoints
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Unafavourable toxicity profile
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Iain BH Tan, Dr, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720926
- Sponsor's protocol ID
- NCC 10-03
- Status last verified
- Mar 2016
- First submitted
- 14 May 2012
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of TKI 258 in Combination With Xeloda and Oxaliplatin in Upfront Treatment of Advanced Colorectal and Gastric Cancer With a Dose Expansion Cohort in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02720926
- Acronym / sponsor ID
- NCC 10-03
- Conditions
- Colorectal Cancer, Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unafavourable toxicity profile
- Enrolment
- 3 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 Mar 2016 (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.
Standard "3+3" dose escalation design of TKI258/XELOX in advanced gastric/gastro-oesophageal and colorectal cancer.
Detailed description
This is a "3+3" dose escalation design with 4 pre-defined TKI258 dose levels (200mg, 300mg, 400mg and 500mg daily with 5 days on and 2 days off schedule) in combination with a fixed standard dose of XELOX (Capecitabine and Oxaliplatin) to establish the recommended phase 2 dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKI258 combined with Xeloda/Oxaliplatin | Experimental | Drug: Xeloda,, Drug: Oxaliplatin, Drug: TKI258TKI258 200 mg once a day (OD) 5 days on/2 days off Capecitabine (Xeloda) 2000 mg/m2 bid d1-14 Oxaliplatin 130mg/m2 d1 q21days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically confirmed gastric, gastro-oesophageal or colorectal adenocarcinoma.
- The gastric or gastro-oesophageal cancer must be locally advanced unresectable or metastatic. Colorectal cancer must be metastatic and for which subsequent resection of all metastatic disease is assessed not to be feasible.
- Age >18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%, see Appendix A).
- Life expectancy of greater than 3 months
Key exclusion criteria (6 listed)
- Patients are not considered to have a "currently active" malignancy if they have TKI258/XELOX phase 1 protocol version 3.3 Dated 30 November 2011 1 4 completed therapy and are considered to have a less than 30% risk of relapse.
- Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TKI258 or XELOX, breastfeeding should be discontinued if the mother is treated with TKI258 or XELOX.
- Patients with prior history of transient ischemia attack or cerebrovascular disease or prior history of ischemia heart disease or myocardia infarction and 2 or more risk factors: ever smoker with > 30 packs per year exposure or on medication for diabetes mellitus or hypertension or hyperlipidemia.
- In addition for the Beginning at dose expansion cohort, the following exclusion criteria apply:
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 |
|---|---|---|
| Xeloda,Also: capecitabineCapecitabine (xeloda): 2000mg/m2, twice a day on Day 1-14; | Drug | TKI258 combined with Xeloda/Oxaliplatin |
| OxaliplatinOxaliplatin: 130mg/m2 day 1 every 21days | Drug | TKI258 combined with Xeloda/Oxaliplatin |
| TKI2584 dose levels of TKI258: 200mg, 300mg, 400mg, 500mg once daily, 5days on and 2 days off; | Drug | TKI258 combined with Xeloda/Oxaliplatin |
Primary outcome
Determine the recommended phase 2 dose of TKI258 in combination with XELOX (Capecitabine and Oxaliplatin)
Time frame: 42 days
2 secondary outcomes
Describe the toxic effects of TKI258 when administered in combination with XELOX chemotherapy.
Time frame: one year
Measure the Area under the plasma concentration versus time curve (AUC) of TKI258 at specific timepoints
Time frame: 42 days
Results and safety
The study was stopped early (reason given: Unafavourable toxicity profile). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Iain BH Tan, Dr principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xeloda,, Oxaliplatin and TKI258 in people with Colorectal Cancer and Gastric Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 16 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: stopped early, as of the sponsor's last update on 28 Mar 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 Singapore. 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 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.
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 was stopped early (reason given: Unafavourable toxicity profile). Results are not available in the source record.
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?
Determine the recommended phase 2 dose of TKI258 in combination with XELOX (Capecitabine and Oxaliplatin) (time frame: 42 days). 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 28 Mar 2016.