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Stomach NeoplasmsPhase 1NCT00553696

Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer

A Phase 1 study testing Cisplatin, S-1 and Sunitinib in people with Stomach Neoplasms, run by Pfizer at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Stomach Neoplasms
What is being tested?
Cisplatin, S-1 and Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
3 sitesJapan
Study dates
Nov 2007to Mar 2014
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of gastric cancer
  • Chemonaive patients
  • Adequate organ function

Who cannot join

  • Patients who meet the contra-indications of S-1 and Cisplatin.
  • Prior chemotherapy failure patients

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • Aichi cancer center central hospital / Medical Oncology

    Nagoya, Aichi-ken, 464-8681

  • Saku Central Hospital, GI Devision

    Saku, Nagano

  • Shizuoka Cancer Center

    Suntougun, Shizuoka, 411-8777

Other trials in Japan

About this study

Official title: A Phase 1 Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic Gastric Cancer

To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer.

Being tested
Cisplatin, S-1, Sunitinib
Keywords
chemotherapy, combination
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Cisplatin 60 mg/m2 on day 1 of each 28 day cycle

  • S-1Drug

    S-1 80 mg/m2 on days 1-21 of each 28 day cycle

  • SunitinibDrug

    Sunitinib 25 mg, 37.5 mg and 50 mg daily S-1 80 mg/m2 on days 1-21 of each 28 day cycle Cisplatin 60 mg/m2 on day 1 of each 28 day cycle

Study groups in NCT00553696
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: Cisplatin; Drug: S-1; Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)

    A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).

    Measured: Cycle 1 (Baseline to Week 4)

Secondary outcomes (14)

  1. Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)

    Measured: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)

    Measured: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

    Measured: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)

  4. Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU

    Measured: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU

    Measured: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)

  6. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

    Measured: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)

  7. Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum

    Measured: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)

  8. Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum

    Measured: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)

  9. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

    Measured: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)

  10. Number of Participants With Objective Response

    Number of participants with objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.

    Measured: Baseline up to 739 days

  11. Number of Participants With Clinical Benefit Response (CBR)

    CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.

    Measured: Baseline up to 739 days

  12. Duration of Response (DR)

    Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to cancer. DR calculated as (the end date for DR minus first subsequent confirmed CR or PR plus 1 day).

    Measured: Baseline up to 739 days

  13. Progression-Free Survival (PFS)

    Median time from the enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (first event date minus enrollment date plus 1 day)

    Measured: Baseline up to 739 days

  14. Time to Progression (TTP)

    Time in months from enrollment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of enrollment plus 1 day). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).

    Measured: Baseline up to 739 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJul 2009
  4. Study completionMar 2014

Resources

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00553696
Sponsor's protocol ID
A6181127
Status last verified
Mar 2015
First submitted
2 Nov 2007
Last updated
13 Mar 2015
Data monitoring committee
Yes

Publications

  • Boku N, Muro K, Machida N, Hashigaki S, Kimura N, Suzuki M, Lechuga M, Miyata Y. Phase I study of sunitinib plus S-1 and cisplatin in Japanese patients with advanced or metastatic gastric cancer. Invest New Drugs. 2014 Apr;32(2):261-70. doi: 10.1007/s10637-013-9948-5. Epub 2013 May 12.

    PubMed 23665950

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cisplatin, S-1 and Sunitinib in people with Stomach Neoplasms, run by Pfizer at 3 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 3 inclusion and 2 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 13 Mar 2015. 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 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 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?

Yes. Results are posted in the registry (first posted 13 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) (time frame: Cycle 1 (Baseline to Week 4)). 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 NCT00553696, 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 13 Mar 2015.

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