search
Back to results

Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer (TESEGAST)

Primary Purpose

Gastric Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tesetaxel
Placebo
Capecitabine
Sponsored by
Genta Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Carcinoma

Eligibility Criteria

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

Key inclusion criteria:

  1. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (Histologically confirmed adenocarcinoma of the lower esophagus acceptable with radiographic or endoscopic documentation of gastroesophageal-junction or proximal-stomach involvement.)
  2. Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
  3. ECOG performance status 0 or 1
  4. Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum-containing agent (Prior adjuvant or neo-adjuvant chemotherapy acceptable provided 6 months elapsed between the end of this therapy and the start of first-line therapy.)
  5. Disease progression after the start of the 1 prior regimen based on computed tomography
  6. Adequate bone marrow, hepatic, and renal function
  7. Ability to swallow an oral solid-dosage form of medication

Key exclusion criteria:

  1. Squamous cell gastric carcinoma
  2. Bone-only metastatic disease
  3. History or presence of brain metastasis or leptomeningeal disease
  4. Operable gastric or gastroesophageal-junction cancer
  5. HER2-positive disease if the patient has not previously been treated with an anti-HER2 agent
  6. Uncontrolled diarrhea, nausea, or vomiting
  7. Known malabsorptive disorder
  8. Significant medical disease other than gastric cancer
  9. Presence of neuropathy > Grade 1 (NCI Common Toxicity Criteria)
  10. Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted agent (indibulin, eribulin, etc.)
  11. Prior radiation therapy to more than 25% of the bone marrow
  12. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
  13. Pregnancy or lactation

Sites / Locations

  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Krankenhaus NordwestRecruiting
  • National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Capecitabine-tesetaxel

Capecitabine-placebo

Arm Description

21-day cycle; tesetaxel 27 mg/m2 orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14

21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Disease control rate
The percentages of patients with complete or partial response of any duration or stable disease lasting at least 6 weeks from the date of randomization (revised RECIST)
Progression-free survival
Calculated from the date of randomization to the date when disease progression is first documented or when the patient dies within 60 days of the last lesion assessment
Response rate in patients with measurable disease
The percentages of patients with complete or partial response (revised RECIST)
Incidence of adverse events
The percentages of patients who experience adverse events by specific adverse event term

Full Information

First Posted
April 5, 2012
Last Updated
July 20, 2012
Sponsor
Genta Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT01573468
Brief Title
Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer
Acronym
TESEGAST
Official Title
A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genta Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is being performed to evaluate the efficacy and safety of capecitabine in combination with tesetaxel versus capecitabine in combination with placebo as second-line treatment for patients with gastric cancer.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
580 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine-tesetaxel
Arm Type
Experimental
Arm Description
21-day cycle; tesetaxel 27 mg/m2 orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
Arm Title
Capecitabine-placebo
Arm Type
Active Comparator
Arm Description
21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
Intervention Type
Drug
Intervention Name(s)
Tesetaxel
Intervention Description
Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo orally once on Day 1 of each cycle
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
When at least 508 events of death have occurred, which is estimated will occur 12 months after the date of randomization of the last patient
Secondary Outcome Measure Information:
Title
Disease control rate
Description
The percentages of patients with complete or partial response of any duration or stable disease lasting at least 6 weeks from the date of randomization (revised RECIST)
Time Frame
Estimated will be assessed 12 months after the date of randomization of the last patient
Title
Progression-free survival
Description
Calculated from the date of randomization to the date when disease progression is first documented or when the patient dies within 60 days of the last lesion assessment
Time Frame
Estimated will be assessed 12 months after the date of randomization of the last patient
Title
Response rate in patients with measurable disease
Description
The percentages of patients with complete or partial response (revised RECIST)
Time Frame
Estimated will be assessed 12 months after the date of randomization of the last patient
Title
Incidence of adverse events
Description
The percentages of patients who experience adverse events by specific adverse event term
Time Frame
Through 30 days after the last dose of study medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key inclusion criteria: Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (Histologically confirmed adenocarcinoma of the lower esophagus acceptable with radiographic or endoscopic documentation of gastroesophageal-junction or proximal-stomach involvement.) Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease ECOG performance status 0 or 1 Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum-containing agent (Prior adjuvant or neo-adjuvant chemotherapy acceptable provided 6 months elapsed between the end of this therapy and the start of first-line therapy.) Disease progression after the start of the 1 prior regimen based on computed tomography Adequate bone marrow, hepatic, and renal function Ability to swallow an oral solid-dosage form of medication Key exclusion criteria: Squamous cell gastric carcinoma Bone-only metastatic disease History or presence of brain metastasis or leptomeningeal disease Operable gastric or gastroesophageal-junction cancer HER2-positive disease if the patient has not previously been treated with an anti-HER2 agent Uncontrolled diarrhea, nausea, or vomiting Known malabsorptive disorder Significant medical disease other than gastric cancer Presence of neuropathy > Grade 1 (NCI Common Toxicity Criteria) Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted agent (indibulin, eribulin, etc.) Prior radiation therapy to more than 25% of the bone marrow Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway Pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mansoor Ahmad, MD, PhD
Phone
908 286-3113
Email
medinfo@genta.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaffer Ajani, MD
Organizational Affiliation
The University of Texas MD Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaffer Ajani, MD
Phone
713-745-3917
First Name & Middle Initial & Last Name & Degree
Jaffer Ajani, MD
Facility Name
Krankenhaus Nordwest
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salah-Eddin Al-Batran, PD Dr. med
Phone
+49 (0) 69 7601 4420
First Name & Middle Initial & Last Name & Degree
Salah-Eddin Al-Batran, PD Dr. med
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Jui Yen, MD
Phone
+886 6 2353535 4620
First Name & Middle Initial & Last Name & Degree
Chia-Jui Yen, MD

12. IPD Sharing Statement

Learn more about this trial

Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer

We'll reach out to this number within 24 hrs