NCT00553696

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 13, 2015

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

November 2, 2007

Results QC Date

March 3, 2015

Last Update Submit

March 3, 2015

Conditions

Stomach Neoplasms

Keywords

chemotherapycombination

Outcome Measures

Primary Outcomes (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).

    Cycle 1 (Baseline to Week 4)

Secondary Outcomes (14)

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

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

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

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

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

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

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

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

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

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

  • +9 more secondary outcomes

Study Arms (1)

A

EXPERIMENTAL
Drug: CisplatinDrug: S-1Drug: Sunitinib

Interventions

CisplatinDRUG

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

A
S-1DRUG

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

A
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

A

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aichi cancer center central hospital / Medical Oncology

Nagoya, Aichi-ken, 464-8681, Japan

Location

Saku Central Hospital, GI Devision

Saku, Nagano, Japan

Location

Shizuoka Cancer Center

Suntougun, Shizuoka, 411-8777, Japan

Location

Related Publications (1)

  • 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.

    PMID: 23665950DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

CisplatinS 1 (combination)Sunitinib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2007

First Posted

November 5, 2007

Study Start

November 1, 2007

Primary Completion

July 1, 2009

Study Completion

March 1, 2014

Last Updated

March 13, 2015

Results First Posted

March 13, 2015

Record last verified: 2015-03

Locations

JP(3)