An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Sunitinib

About this trial

This is an interventional treatment trial for Stomach Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented Disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion Evidence of measurable disease by radiographic technique Adequate organ function. Exclusion Criteria: Clinically relevant ascites (i.e. requiring paracentesis) Severe weight loss NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment Diagnosis of second malignancy within last 3 years History of or known brain metastases, spinal cord compression, or carcinomatous meningitis Known HIV Serious acute or chronic illness Current treatment on another clinical trial Pregnant or breastfeeding

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed

Outcomes

Primary Outcome Measures

Best Overall Response

Number of patients with best overall response = complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Objective Response (Complete Response (CR) or Partial Response (PR))

Number of patients with Objective Response (OR): confirmed CR or confirmed PR according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Secondary Outcome Measures

Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks

Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR or stable disease (SD) for at least 24 weeks on study according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progessive disease (PD) taking as a reference the smallest sum of the longest dimensions since the treatment started.

Duration of Response (CR or PR)

Time from the first documentation of confirmed objective response (CR or PR) to the first documentation of disease progression or to death due to any cause. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Progression-Free Survival

Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause. PFS was calculated as (first event date minus the date of first dose plus 1) divided by 7.

Time to Tumor Progression (TTP)

Time from the start of study treatment to the first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose plus 1) divided by 7.

Overall Survival

Time from the date of first dose of study medication to the date of death due to any cause. OS was calculated as (date of death minus the date of first dose date plus 1) divided by 7.

Full Information

NCT ID

NCT00226811

First Posted

September 23, 2005

Last Updated

March 10, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00226811

Brief Title

An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy

Official Title

An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Progressing Or Recurring After One Prior Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients. Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. All patients received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients were followed up in order to collect information on further antineoplastic therapy and survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Experimental

Arm Description

50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Intervention Description

50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed

Primary Outcome Measure Information:

Title

Best Overall Response

Description

Number of patients with best overall response = complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time Frame

From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter

Title

Objective Response (Complete Response (CR) or Partial Response (PR))

Description

Number of patients with Objective Response (OR): confirmed CR or confirmed PR according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time Frame

From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter

Secondary Outcome Measure Information:

Title

Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks

Description

Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR or stable disease (SD) for at least 24 weeks on study according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progessive disease (PD) taking as a reference the smallest sum of the longest dimensions since the treatment started.

Time Frame

From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or clinical benefit response for at least 24 weeks on study

Title

Duration of Response (CR or PR)

Description

Time from the first documentation of confirmed objective response (CR or PR) to the first documentation of disease progression or to death due to any cause. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Time Frame

Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer

Title

Progression-Free Survival

Description

Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause. PFS was calculated as (first event date minus the date of first dose plus 1) divided by 7.

Time Frame

From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death

Title

Time to Tumor Progression (TTP)

Description

Time from the start of study treatment to the first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose plus 1) divided by 7.

Time Frame

From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter

Title

Overall Survival

Description

Time from the date of first dose of study medication to the date of death due to any cause. OS was calculated as (date of death minus the date of first dose date plus 1) divided by 7.

Time Frame

From start of study treatment until death

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented Disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion Evidence of measurable disease by radiographic technique Adequate organ function. Exclusion Criteria: Clinically relevant ascites (i.e. requiring paracentesis) Severe weight loss NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment Diagnosis of second malignancy within last 3 years History of or known brain metastases, spinal cord compression, or carcinomatous meningitis Known HIV Serious acute or chronic illness Current treatment on another clinical trial Pregnant or breastfeeding

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

Facility Name

Pfizer Investigational Site

City

Beijing

ZIP/Postal Code

100036

Country

China

Facility Name

Pfizer Investigational Site

City

Beijing

Country

China

Facility Name

Pfizer Investigational Site

City

Guangzhou

ZIP/Postal Code

510515

Country

China

Facility Name

Pfizer Investigational Site

City

Hong Kong

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Shatin

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Ancona

ZIP/Postal Code

60020

Country

Italy

Facility Name

Pfizer Investigational Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Pfizer Investigational Site

City

Kashiwa

State/Province

Chiba

Country

Japan

Facility Name

Pfizer Investigational Site

City

Suntougun

State/Province

Shizuoka

Country

Japan

Facility Name

Pfizer Investigational Site

City

Chuo-ku

State/Province

Tokyo

Country

Japan

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Kwei-Shan

State/Province

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181054&StudyName=An%20International%20Phase%202%20Study%20Of%20SU011248%20In%20Patients%20With%20Advanced%20/%20Metastatic%20Gastric%20Cancer%20Failing%20Chemotherapy

Description

To obtain contact information for a study center near you, click here.

Stomach Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial