Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer

NCT00983801 | Completed Phase 2 Results

• 1 other identifier: CA163-200
• Study Type: interventional
• Target: 58
• Locations: 5 countries
• Sites: 9

Brief Summary

The purpose of this study was to determine whether ixabepilone is effective in the treatment of unresectable or metastatic gastric cancer in Asian participants.

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)

  Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to modified RECIST, as determined by investigator. CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node, the lesions short axis of all nodes measuring \<10 mm. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A 2-sided confidence interval (CI) was computed using Clopper-Pearson method.

  During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)

Secondary Outcomes (7)

• Time to Response

  Assessed every 6 weeks (± 1 week) starting from the first dose of study therapy until CR or PR (up to 12.1 weeks.)

• Duration of Response

  From the date of first PR or CR assessment to the date of progression, death, or last tumor assessment (maximum: 4.1 months)

• Progression Free Survival (PFS)

  From the date of initiation of study therapy to the date of progression (up to 8.1 months).

• Percentage of Participants With Disease Control Rate

  During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)

• Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0

  Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3 to 30 weeks)

Other Outcomes (1)

• Number of Participants With Best Response as Assessed With Modified RECIST

  During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (to a maximum follow up for tumor response of 30 weeks)

Study Arms (1)

Ixabepilone

EXPERIMENTAL

Drug: Ixabepilone

Interventions

Ixabepilone DRUG

Vial, Injection, Intravenous (IV), 40 mg/m\^2, Every 21 days, Up to 8 cycles or until disease progression or intolerable toxicity. Additional treatment was given in agreement by both the investigator and sponsor. Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day (3 week) cycle provided the participant met the retreatment criteria.

Also known as: Ixempra, BMS-247550

Ixabepilone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed gastric carcinoma originating from the stomach or gastroesophageal junction
• Must have unresectable or metastatic disease
• Asian ethnicity
• Must have failed prior fluoropyrimidine-based chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• measurable disease by with Response Evaluation Criteria in Solid Tumors (RECIST) guidelines

You may not qualify if:

• \>1 prior chemotherapy regimen in the metastatic setting or \>2 prior chemotherapy if subject also received adjuvant therapy
• Receipt of prior ixabepilone
• ECOG ≥2
• Known brain or meningeal metastasis
• Known viral hepatitis
• Prior taxane therapy
• Uncontrolled non-cancer related medical condition
• Second malignancy
• Peripheral neuropathy ≥ grade 2
• Inadequate hematologic, renal and hepatic function

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (9)

Local Institution

Hong Kong, B, Hong Kong

Location

Local Institution

Nagoya, Aichi-ken, 4648681, Japan

Location

Local Institution

Sunto-Gun, Shizuoka, 4118777, Japan

Location

Local Institution

Singapore, 169610, Singapore

Location

Local Institution

Seoul, 135-710, South Korea

Location

Local Institution

Seoul, 136-705, South Korea

Location

Local Institution

Seoul, 138-736, South Korea

Location

Local Institution

Taipei, 112, Taiwan

Location

Local Institution

Taoyuan Hsien, 333, Taiwan

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 24, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 28, 2020
• Results First Posted: September 19, 2012

Record last verified: 2020-10

Locations

KR (3); TW (2); HK (1); JP (2); SG (1)