Gastric CancerPhase 2NCT00952497
A Study of Telatinib in Combination With Chemotherapy in Subjects With Advanced Gastric Cancer
A Phase 2 study testing Cisplatin, Capecitabine, Telatinib in people with Gastric Cancer, run by ACT Biotech, Inc at 11 sites in 2 countries.
Trial summary
The objectives of this study are to evaluate the anti-tumor activity, safety, and tolerability of telatinib when used in combination with chemotherapy (capecitabine and cisplatin) as first-line therapy in subjects with advanced gastric cancer. 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?
- Cisplatin, Capecitabine, Telatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Jun 2009to Jan 2012
- Phase
- Phase 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 confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy
- Measurable disease: At least 1 measurable metastatic lesion that has not been irradiated; The lesion will be measured according to RECIST and be evaluated radiologically within 28 days prior to study entry
- ECOG performance status of 0 or 1 at study entry
- Adequate bone marrow, liver and renal function
- Women of childbearing potential:Negative serum pregnancy test within 7 days and must agree to use adequate contraception (barrier method of birth control) prior to study entry, for the duration of study participation and 28 days after the last study drug dosing
Who cannot join
- Previous chemotherapy for locally advanced or metastatic gastric cancer:prior neoadjuvant or adjuvant chemotherapy completed at least 6 months prior to study entry is allowed
- Previous anti-angiogenic therapy: Anti VEGF or VEGFR tyrosine kinase inhibitor such as bevacizumab, sorafenib, sunitinib, AZD2171
- Previous total platinum dose >300 mg/m2: total prior platinum dose of ≤300 mg/m2 will be allowed in the adjuvant or neo-adjuvant setting
- Candidates for curative therapy
- Clinical or radiographic evidence of brain metastasis
- Cardiac disease; uncontrolled hypertension; hemorrhage/bleeding events
Show all 9Show fewer
- Known or suspected allergy to any component of telatinib, cisplatin or capecitabine
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Unable to take oral medications that could affect oral intake of capecitabine and telatinib
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Spain6 sites
Hospital Vall d' Hebron
Barcelona, 08035
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Marques de Valdecilla
Santander, 39008
United States5 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Central Georgia Cancer Care, P.C.
Macon, Georgia, 31201
The West Clinic
Memphis, Tennessee, 38120
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Phase 2 Open-Label Study Evaluating the Efficacy and Safety of Telatinib in Combination With Chemotherapy as First-Line Therapy in Subjects With Advanced Gastric Cancer
The objectives of this study are to evaluate the anti-tumor activity, safety, and tolerability of telatinib when used in combination with chemotherapy (capecitabine and cisplatin) as first-line therapy in subjects with advanced gastric cancer. The primary objective is to assess progression free survival (PFS) in subjects receiving telatinib in combination with chemotherapy (capecitabine and cisplatin). The secondary objectives are to assess overall survival, overall response rate, safety and tolerability, pharmacokinetics and biomarkers.
- Conditions
- Gastric Cancer
- Being tested
- Cisplatin, Capecitabine, Telatinib
- Keywords
- Gastric Cancer, Gastro-Esophageal Cancer, GE-Junction, Advanced Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin, Capecitabine, TelatinibDrug
Subjects will receive: Chemotherapy (capecitabine and cisplatin) and telatinib Capecitabine will be administered (1000 mg/m2) twice daily for 14 days followed by a 7-day rest period. Cisplatin (80 mg/m2) will be given as a 1-3 hour infusion once every 3 weeks. Telatinib (3 tablets) will be administered orally, twice daily as a continuous administration. After a maximum of 6 cycles of cisplatin, subjects continue with capecitabine and telatinib or monotherapy with either study drug,depending on the toxicity experienced by the subject, until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin, Capecitabine, Telatinib | Experimental | Not described Receives: Drug: Cisplatin, Capecitabine, Telatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to assess progression free survival (PFS). PFS will be measured from the date of first study drug administration to the date of first scan that first documents disease progression.
Measured: 6 months
Secondary outcomes (1)
Other efficacy variables are overall survival, overall response rate, safety and tolerability. Exploratory analyses may be performed to investigate the correlation of biomarker status with treatment effect and response.
Measured: 18 months from start of enrollment to evaluation of primary endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACT Biotech, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Freeman, MD, Study director, ACT Biotech, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952497
- Sponsor's protocol ID
- TEL0805
- Status last verified
- Feb 2012
- First submitted
- 30 Jul 2009
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label Study Evaluating the Efficacy and Safety of Telatinib in Combination With Chemotherapy as First-Line Therapy in Subjects With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00952497
- Acronym / sponsor ID
- TEL0805
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Gastro-Esophageal Cancer, GE-Junction, Advanced Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- ACT Biotech, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Aug 2009 (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.
The objectives of this study are to evaluate the anti-tumor activity, safety, and tolerability of telatinib when used in combination with chemotherapy (capecitabine and cisplatin) as first-line therapy in subjects with advanced gastric cancer. The primary objective is to assess progression free survival (PFS) in subjects receiving telatinib in combination with chemotherapy (capecitabine and cisplatin). The secondary objectives are to assess overall survival, overall response rate, safety and tolerability, pharmacokinetics and biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin, Capecitabine, Telatinib | Experimental | Drug: Cisplatin, Capecitabine, Telatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy
- Measurable disease: At least 1 measurable metastatic lesion that has not been irradiated; The lesion will be measured according to RECIST and be evaluated radiologically within 28 days prior to study entry
- ECOG performance status of 0 or 1 at study entry
- Adequate bone marrow, liver and renal function
- Women of childbearing potential:Negative serum pregnancy test within 7 days and must agree to use adequate contraception (barrier method of birth control) prior to study entry, for the duration of study participation and 28 days after the last study drug dosing
Key exclusion criteria (9 listed)
- Previous chemotherapy for locally advanced or metastatic gastric cancer:prior neoadjuvant or adjuvant chemotherapy completed at least 6 months prior to study entry is allowed
- Previous anti-angiogenic therapy: Anti VEGF or VEGFR tyrosine kinase inhibitor such as bevacizumab, sorafenib, sunitinib, AZD2171
- Previous total platinum dose >300 mg/m2: total prior platinum dose of ≤300 mg/m2 will be allowed in the adjuvant or neo-adjuvant setting
- Candidates for curative therapy
- Clinical or radiographic evidence of brain metastasis
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 |
|---|---|---|
| Cisplatin, Capecitabine, TelatinibSubjects will receive: Chemotherapy (capecitabine and cisplatin) and telatinib Capecitabine will be administered (1000 mg/m2) twice daily for 14 days followed by a 7-day rest period. Cisplatin (80 mg/m2) will be given as a 1-3 hour infusion once every 3 weeks. Telatinib (3 tablets) will be administered orally, twice daily as a continuous administration. After a maximum of 6 cycles of cisplatin, subjects continue with capecitabine and telatinib or monotherapy with either study drug,depending on the toxicity experienced by the subject, until disease progression. | Drug | Cisplatin, Capecitabine, Telatinib |
Primary outcome
The primary objective is to assess progression free survival (PFS). PFS will be measured from the date of first study drug administration to the date of first scan that first documents disease progression.
Time frame: 6 months
1 secondary outcome
Other efficacy variables are overall survival, overall response rate, safety and tolerability. Exploratory analyses may be performed to investigate the correlation of biomarker status with treatment effect and response.
Time frame: 18 months from start of enrollment to evaluation of primary endpoint
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 8 Feb 2012.
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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.
Scott Freeman, MD study director
ACT Biotech, Inc
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, Capecitabine, Telatinib in people with Gastric Cancer, run by ACT Biotech, Inc at 11 sites in 2 countries.
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 5 inclusion and 9 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 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, United States. 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 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?
The primary objective is to assess progression free survival (PFS). PFS will be measured from the date of first study drug administration to the date of first scan that first documents disease progression. (time frame: 6 months). 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 8 Feb 2012.