Brief Summary

The purpose of this study is to determine the safe and tolerable dose of axitinib given together with cisplatin and capecitabine in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Apr 2009

Typical duration for phase_1

Geographic Reach

2 countries

5 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

3.5 years study duration

First Submitted

Initial submission to the registry

February 11, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed

2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed

2.3 years until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed

Last Updated

November 27, 2013

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

February 11, 2009

Results QC Date

February 25, 2012

Last Update Submit

October 17, 2013

Conditions

Stomach Neoplasms Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs)
DLT = Grade (GR) 2 proteinuria; GR3 nonhematological toxicity (NHT) (excluding alopecia and those that can be controlled with appropriate treatment) for greater than or equal to (\>=)7 days, GR3 thrombocytopenia with active bleeding; GR \>=3 febrile neutropenia (NP) or NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for \>=7 days; \>= 1/2 teaspoon per day hemoptysis; any treatment related toxicity with \>3 consecutive days of capecitabine or 5 consecutive days of axitinib missed doses per cycle; delayed toxicity recovery \>14 days.
Baseline up to Day 21 of Cycle 1

Secondary Outcomes (14)

Maximum Observed Plasma Concentration (Cmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin
0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on Cycle 1 (C1) Day -1 (D-1), C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin
0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Capecitabine, Capecitabine's Metabolites and Cisplatin
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1
Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] for Axitinib
0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1
Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUC (0 - ∞)] for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin
0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1
+9 more secondary outcomes

Other Outcomes (1)

Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Cisplatin and Capecitabine
Baseline up to Day 21 of Cycle 1

Study Arms (1)

A

EXPERIMENTAL

Drug: axitinibDrug: capecitabineDrug: cisplatin

Interventions

axitinibDRUG

Twice daily oral dose of axitinib continuously depending upon side effects observed. Starting dose is 5mg twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.

capecitabineDRUG

Given orally twice daily for 14 days followed by 7 days of drug free period. Starting dose is 1000mg/m\^2 twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.

cisplatinDRUG

Given through a vein on Day 1 of every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. The starting dose is 80 mg/m\^2 on day 1.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

confirmed diagnosis of stomach cancer
advanced stomach cancer of stage IV
adequate blood chemistry, blood counts and kidney function
willing to participate to study requirements and sign an informed consent document

You may not qualify if:

prior chemotherapy for stomach cancer in its advanced stage
excessive toxicities related to prior therapies
pregnant or breastfeeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (5)

Pfizer Investigational Site

Kashiwa, Chiba, Japan

Location

Pfizer Investigational Site

Yufu, Oita Prefecture, Japan

Location

Pfizer Investigational Site

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Pfizer Investigational Site

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Related Publications (1)

Oh DY, Doi T, Shirao K, Lee KW, Park SR, Chen Y, Yang L, Valota O, Bang YJ. Phase I Study of Axitinib in Combination with Cisplatin and Capecitabine in Patients with Previously Untreated Advanced Gastric Cancer. Cancer Res Treat. 2015 Oct;47(4):687-96. doi: 10.4143/crt.2014.225. Epub 2015 Feb 12.
PMID: 25687867DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

AxitinibCapecitabineCisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Limitations and Caveats

AUC (0-24) was evaluated and reported for axitinib instead of AUClast as AUC0-24 was a more appropriate measure of steady-state exposure for this drug.

Results Point of Contact

Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.

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: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2009

Study Completion

October 1, 2012

Last Updated

November 27, 2013

Results First Posted

March 26, 2012

Record last verified: 2013-10

Locations

JP(2)KR(3)

Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Other Outcomes (1)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Other Outcomes (1)

Study Arms (1)

A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations