Gastric CarcinomaPhase 2TESEGASTNCT01573468
Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer
A Phase 2 study testing Tesetaxel and Capecitabine in people with Gastric Carcinoma, run by Genta Incorporated at 3 sites in 3 countries.
Trial summary
This study is being performed to evaluate the efficacy and safety of capecitabine in combination with tesetaxel versus capecitabine in combination with placebo as second-line treatment for patients with gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Carcinoma
- What is being tested?
- Tesetaxel and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 580 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2012to Aug 2014
- 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 gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (Histologically confirmed adenocarcinoma of the lower esophagus acceptable with radiographic or endoscopic documentation of gastroesophageal-junction or proximal-stomach involvement.)
- Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
- ECOG performance status 0 or 1
- Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum-containing agent (Prior adjuvant or neo-adjuvant chemotherapy acceptable provided 6 months elapsed between the end of this therapy and the start of first-line therapy.)
- Disease progression after the start of the 1 prior regimen based on computed tomography
- Adequate bone marrow, hepatic, and renal function
- Ability to swallow an oral solid-dosage form of medication
Who cannot join
- Squamous cell gastric carcinoma
- Bone-only metastatic disease
- History or presence of brain metastasis or leptomeningeal disease
- Operable gastric or gastroesophageal-junction cancer
- HER2-positive disease if the patient has not previously been treated with an anti-HER2 agent
- Uncontrolled diarrhea, nausea, or vomiting
Show all 13Show fewer
- Known malabsorptive disorder
- Significant medical disease other than gastric cancer
- Presence of neuropathy > Grade 1 (NCI Common Toxicity Criteria)
- Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted agent (indibulin, eribulin, etc.)
- Prior radiation therapy to more than 25% of the bone marrow
- Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
- Pregnancy or lactation
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site, 1 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jaffer Ajani, MD, 713-745-3917
Jaffer Ajani, MD
Germany1 site, 1 recruiting
- Recruiting
Krankenhaus Nordwest
Frankfurt, 60488
Salah-Eddin Al-Batran, PD Dr. med, +49 (0) 69 7601 4420
Salah-Eddin Al-Batran, PD Dr. med
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Chia-Jui Yen, MD, +886 6 2353535 4620
Chia-Jui Yen, MD
About this study
Official title: A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer
This study is being performed to evaluate the efficacy and safety of capecitabine in combination with tesetaxel versus capecitabine in combination with placebo as second-line treatment for patients with gastric cancer.
- Conditions
- Gastric Carcinoma
- Being tested
- Tesetaxel, Placebo, Capecitabine
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesetaxelDrug
Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle
PlaceboDrug
Placebo orally once on Day 1 of each cycle
CapecitabineDrug
Also called Xeloda
Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine-tesetaxel | Experimental | 21-day cycle; tesetaxel 27 mg/m2 orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14 Receives: Drug: Tesetaxel; Drug: Capecitabine |
| Capecitabine-placebo | Active comparator | 21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14 Receives: Drug: Placebo; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: When at least 508 events of death have occurred, which is estimated will occur 12 months after the date of randomization of the last patient
Secondary outcomes (4)
Disease control rate
The percentages of patients with complete or partial response of any duration or stable disease lasting at least 6 weeks from the date of randomization (revised RECIST)
Measured: Estimated will be assessed 12 months after the date of randomization of the last patient
Progression-free survival
Calculated from the date of randomization to the date when disease progression is first documented or when the patient dies within 60 days of the last lesion assessment
Measured: Estimated will be assessed 12 months after the date of randomization of the last patient
Response rate in patients with measurable disease
The percentages of patients with complete or partial response (revised RECIST)
Measured: Estimated will be assessed 12 months after the date of randomization of the last patient
Incidence of adverse events
The percentages of patients who experience adverse events by specific adverse event term
Measured: Through 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 posted9 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2014 (estimated)
- Study completionAug 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaffer Ajani, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573468
- Sponsor's protocol ID
- TOG301
- Other IDs
- 2010-022164-12
- Acronym
- TESEGAST
- Status last verified
- Jul 2012
- First submitted
- 5 Apr 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer
- ClinicalTrials.gov ID
- NCT01573468
- Acronym / sponsor ID
- TESEGAST / TOG301
- Conditions
- Gastric Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 9 Apr 2012 (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.
This study is being performed to evaluate the efficacy and safety of capecitabine in combination with tesetaxel versus capecitabine in combination with placebo as second-line treatment for patients with gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine-tesetaxel | Experimental | Drug: Tesetaxel, Drug: Capecitabine21-day cycle; tesetaxel 27 mg/m2 orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14 |
| Capecitabine-placebo | Active comparator | Drug: Placebo, Drug: Capecitabine21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (Histologically confirmed adenocarcinoma of the lower esophagus acceptable with radiographic or endoscopic documentation of gastroesophageal-junction or proximal-stomach involvement.)
- Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
- ECOG performance status 0 or 1
- Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum-containing agent (Prior adjuvant or neo-adjuvant chemotherapy acceptable provided 6 months elapsed between the end of this therapy and the start of first-line therapy.)
- Disease progression after the start of the 1 prior regimen based on computed tomography
Key exclusion criteria (13 listed)
- Squamous cell gastric carcinoma
- Bone-only metastatic disease
- History or presence of brain metastasis or leptomeningeal disease
- Operable gastric or gastroesophageal-junction cancer
- HER2-positive disease if the patient has not previously been treated with an anti-HER2 agent
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 |
|---|---|---|
| TesetaxelTesetaxel 27 mg/m2 orally once on Day 1 of each cycle | Drug | Capecitabine-tesetaxel |
| PlaceboPlacebo orally once on Day 1 of each cycle | Drug | Capecitabine-placebo |
| CapecitabineAlso: XelodaCapecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle | Drug | Capecitabine-placebo, Capecitabine-tesetaxel |
Primary outcome
Overall survival
Time frame: When at least 508 events of death have occurred, which is estimated will occur 12 months after the date of randomization of the last patient
4 secondary outcomes
Disease control rate
Time frame: Estimated will be assessed 12 months after the date of randomization of the last patient
Progression-free survival
Time frame: Estimated will be assessed 12 months after the date of randomization of the last patient
Response rate in patients with measurable disease
Time frame: Estimated will be assessed 12 months after the date of randomization of the last patient
Incidence of adverse events
Time frame: Through 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 24 Jul 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.
Jaffer Ajani, MD study chair
M.D. Anderson Cancer Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesetaxel and Capecitabine in people with Gastric Carcinoma, run by Genta Incorporated at 3 sites in 3 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 7 inclusion and 13 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 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany, Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mansoor Ahmad, MD, PhD (908 286-3113, medinfo@genta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: When at least 508 events of death have occurred, which is estimated will occur 12 months after the date of randomization of the last patient). 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 24 Jul 2012.