Gastric CarcinomaPhase 1/2NCT01348009
Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer
A Phase 1/2 study testing Tesetaxel-capecitabine-cisplatin in people with Gastric Carcinoma, run by Genta Incorporated at 1 site in South Korea.
Trial summary
Cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Carcinoma
- What is being tested?
- Tesetaxel-capecitabine-cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Jan 2014
- Phase
- Phase 1/2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary Inclusion Criteria:
- At least 20 years of age
- Histologically or cytologically confirmed gastric carcinoma, including gastric or gastroesophageal-junction adenocarcinoma.
- Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
- Previously untreated, unresectable advanced (M0) or unresectable metastatic (M1) disease except for prior adjuvant (or neo-adjuvant) chemotherapy.
- ECOG performance status 0 or 1
- At least 4 weeks and recovery from effects of prior major surgery
- Adequate bone marrow, hepatic, and renal function
Primary Exclusion Criteria:
- Operable gastric or gastroesophageal-junction cancer
- Known brain metastasis
- Second cancer
- Previous adjuvant or neo-adjuvant chemotherapy with capecitabine and cisplatin in combination. (Previous adjuvant or neo-adjuvant monotherapy with capecitabine or S-1 or therapy with S-1 and cisplatin in combination or 5-FU and cisplatin in combination is allowed.)
- Uncontrolled diarrhea
- Nausea or vomiting for at least 3 consecutive days within the 14 days prior to registration despite the administration of standard antiemetic therapy
- Symptomatic peripheral neuropathy ≥ Grade 2
- Malabsorption syndrome or other disease that significantly affects gastrointestinal function
- Other uncontrolled systemic illness
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Cancer Center, Yonsei University College of Medicine
Seoul
Sun Young Rha, MD, 82-2-2228-8050
Sun Young Rha, MD, PhD
About this study
Official title: A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer
Cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer.
This study is being performed to evaluate an orally administered taxane (tesetaxel) in combination with cisplatin and capecitabine in previously untreated patients with gastric cancer.
- Conditions
- Gastric Carcinoma
- Being tested
- Tesetaxel-capecitabine-cisplatin
- Keywords
- Gastric cancer, First-line therapy, Tesetaxel, Taxane, Capecitabine, Oral fluoropyrimidine, Cisplatin, Platinum
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tesetaxel-capecitabine-cisplatinDrug
Also called DJ-927, Xeloda, CDDP, Platinol
Phase 1: Tesetaxel orally on Day 1 of each cycle at dose of 18, 21, 24, or 27 mg/m2. If no dose-limiting toxicity, at least 3 subjects will be treated at each dose level until the maximum tolerated dose or the maximum dose of 27 mg/m2 is reached. At each tesetaxel dose level, capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1.
Phase 2: Tesetaxel orally on Day 1 of each cycle at dose determined in Phase 1. Capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Tesetaxel-capecitabine-cisplatin | Experimental | Not described Receives: Drug: Tesetaxel-capecitabine-cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate (in Phase 2 portion of study)
Measured: 6 months from the date of first dose of study medication
Secondary outcomes (9)
Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study)
The dose of tesetaxel in mg/m2 will be determined for Phase 2 based on the occurrence of dose-limiting toxicities in Phase 1.
Measured: Up to 21 days after first dose of study medication
Response rate, as defined in revised RECIST (in Phase 2 portion of study)
Measured: Up to 12 months following the date of first dose of study medication
Duration of response (in Phase 2 portion of study)
Measured: Up to 12 months following the date of first dose of study medication
Rate of responses at least 3 months in duration (in Phase 2 portion of study)
Measured: Up to 12 months following the date of first dose of study medication
Disease control rate, which is defined as the percentage of patients with a response of any duration or stable disease at least 6 weeks in duration (in Phase 2 portion of study)
Measured: Up to 12 months following the date of first dose of study medication
Durable response rate, which is defined as the percentage of patients with a response at least 6 months in duration (in Phase 2 portion of study)
Measured: Up to 12 months following the date of first dose of study medication
Progression-free survival (in Phase 2 portion of study)
Measured: Up to 12 months following the date of first dose of study medication
Overall survival (in Phase 2 portion of study)
Measured: Up to 12 months following the date of first dose of study medication
Percentage of patients with adverse events (in Phase 1 and Phase 2 portions)
Measured: Up to 30 days after the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sun Young Rha, MD, PhD, Principal investigator, Yonsei Cancer Center, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348009
- Sponsor's protocol ID
- TOPK105
- Status last verified
- Mar 2012
- First submitted
- 18 Apr 2011
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01348009
- Acronym / sponsor ID
- TOPK105
- Conditions
- Gastric Carcinoma
- Keywords
- Gastric cancer, First-line therapy, Tesetaxel, Taxane, Capecitabine, Oral fluoropyrimidine, Cisplatin, Platinum
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 5 May 2011 (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.
Cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer.
This study is being performed to evaluate an orally administered taxane (tesetaxel) in combination with cisplatin and capecitabine in previously untreated patients with gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tesetaxel-capecitabine-cisplatin | Experimental | Drug: Tesetaxel-capecitabine-cisplatin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Tesetaxel-capecitabine-cisplatinAlso: DJ-927, Xeloda, CDDP, PlatinolPhase 1: Tesetaxel orally on Day 1 of each cycle at dose of 18, 21, 24, or 27 mg/m2. If no dose-limiting toxicity, at least 3 subjects will be treated at each dose level until the maximum tolerated dose or the maximum dose of 27 mg/m2 is reached. At each tesetaxel dose level, capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1. Phase 2: Tesetaxel orally on Day 1 of each cycle at dose determined in Phase 1. Capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1. | Drug | Tesetaxel-capecitabine-cisplatin |
Primary outcome
Progression-free survival rate (in Phase 2 portion of study)
Time frame: 6 months from the date of first dose of study medication
9 secondary outcomes
Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study)
Time frame: Up to 21 days after first dose of study medication
Response rate, as defined in revised RECIST (in Phase 2 portion of study)
Time frame: Up to 12 months following the date of first dose of study medication
Duration of response (in Phase 2 portion of study)
Time frame: Up to 12 months following the date of first dose of study medication
Rate of responses at least 3 months in duration (in Phase 2 portion of study)
Time frame: Up to 12 months following the date of first dose of study medication
Disease control rate, which is defined as the percentage of patients with a response of any duration or stable disease at least 6 weeks in duration (in Phase 2 portion of study)
Time frame: Up to 12 months following the date of first dose of study medication
Durable response rate, which is defined as the percentage of patients with a response at least 6 months in duration (in Phase 2 portion of study)
Time frame: Up to 12 months following the date of first dose of study medication
Progression-free survival (in Phase 2 portion of study)
Time frame: Up to 12 months following the date of first dose of study medication
Overall survival (in Phase 2 portion of study)
Time frame: Up to 12 months following the date of first dose of study medication
Percentage of patients with adverse events (in Phase 1 and Phase 2 portions)
Time frame: Up to 30 days after the last dose of study medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 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.
Sun Young Rha, MD, PhD principal investigator
Yonsei Cancer Center, Yonsei University College of Medicine
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 Tesetaxel-capecitabine-cisplatin in people with Gastric Carcinoma, run by Genta Incorporated 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?
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 13 Mar 2012. 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. 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?
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?
Progression-free survival rate (in Phase 2 portion of study) (time frame: 6 months from the date of first dose of study medication). 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 13 Mar 2012.