Gastric CancerPhase 2NCT00661167
Phase II Study of ABI-007 for Gastric Cancer
A Phase 2 study testing ABI-007 in people with Gastric Cancer, run by Taiho Pharmaceutical Co., Ltd. at 10 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- ABI-007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 10 sitesJapan
- Study dates
- Apr 2008to Dec 2011
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed gastric adenocarcinoma
- Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence
- Age: 20 - 74
- At least one measurable lesion by RECIST criteria
Who cannot join
- History of Taxans use
- Patients with another active malignancy
- Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE)
- Chronic treatment with steroids
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
National Kyusyu Cancer Center
Fukuoka, Fukuoka, 811- 1395
Saitama International medical center-comprehensive cancer center, Saitama Medical University
Hidaka, Saitama, 350-1298
Kochi Health Sciences Center
Kochi, Kochi, 781- 855
Shikoku Cancer Center
Matsuyama, Ehime, 791- 0280
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
Kitasato University East Hospital
Sagamihara, Kanagawa, 228-8520
Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare
Saku, Nagano, 384-0301
Shizuoka Cancer Center
Sunto, Shizuoka, 411- 8777
Kouseiren Takaoka Hospital
Takaoka, Toyama, 933- 8555
Osaka Medical College Hospital
Takatsuki, Osaka, 569- 8686
About this study
Official title: Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.
The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence.
- Conditions
- Gastric Cancer
- Being tested
- ABI-007
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-007Drug
ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ABI-007 Receives: Drug: ABI-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: During chemotherapy
Secondary outcomes (4)
Safety
Measured: During chemotherapy
Progression-free survival
Measured: Until progression
Overall survival
Measured: Over a year form randomaization
Disease control rate
Measured: Duration chemoterapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nagahiro Saijo, MD, Study chair, Kinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661167
- Sponsor's protocol ID
- Taiho10041040
- Status last verified
- Jan 2012
- First submitted
- 16 Apr 2008
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sasaki Y, Nishina T, Yasui H, Goto M, Muro K, Tsuji A, Koizumi W, Toh Y, Hara T, Miyata Y. Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer. Cancer Sci. 2014 Jul;105(7):812-7. doi: 10.1111/cas.12419. Epub 2014 Jul 7.
PubMed 24716542
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.
- ClinicalTrials.gov ID
- NCT00661167
- Acronym / sponsor ID
- Taiho10041040
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Apr 2008 (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 purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ABI-007ABI-007 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed gastric adenocarcinoma
- Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence
- Age: 20 - 74
- At least one measurable lesion by RECIST criteria
Key exclusion criteria (4 listed)
- History of Taxans use
- Patients with another active malignancy
- Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE)
- Chronic treatment with steroids
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 |
|---|---|---|
| ABI-007ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops. | Drug | 1 |
Primary outcome
Overall response rate
Time frame: During chemotherapy
4 secondary outcomes
Safety
Time frame: During chemotherapy
Progression-free survival
Time frame: Until progression
Overall survival
Time frame: Over a year form randomaization
Disease control rate
Time frame: Duration chemoterapy
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 18 Jan 2012.
- Derived from this study: PubMed 24716542Sasaki Y, Nishina T, Yasui H, Goto M, Muro K, Tsuji A, Koizumi W, Toh Y, Hara T, Miyata Y. Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer. Cancer Sci. 2014 Jul;105(7):812-7. doi: 10.1111/cas.12419. Epub 2014 Jul 7.
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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.
Nagahiro Saijo, MD study chair
Kinki University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABI-007 in people with Gastric Cancer, run by Taiho Pharmaceutical Co., Ltd. at 10 sites in Japan.
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 4 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: finished, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. 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?
Overall response rate (time frame: During chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00661167, which also lists 1 linked publication.
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 18 Jan 2012.