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A Phase II Study of Tesetaxel Administered at a Flat Dose Once Every 21 Days as Second-line Therapy to Subjects With Advanced Gastric Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Stomach, Adenocarcinoma of Esophagogastric Junction

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Trial Information

A Phase II Study of Tesetaxel Administered at a Flat Dose Once Every 21 Days as Second-line Therapy to Subjects With Advanced Gastric Cancer

Inclusion Criteria


Primary inclusion criteria:

- Confirmed diagnosis of adenocarcinoma of the stomach or esophagogastric junction

- Measurable disease (revised RECIST; Version 1.1) based on computed tomography

- Eastern Cooperative Oncology Group performance status 0 or 1

- Treatment with only 1 prior regimen (as first-line therapy) and that regimen included
a fluoropyrimidine and/or a platinum analogue

- Documented disease progression within 4 months of the last dose of the 1 prior
regimen

- Adequate bone marrow, hepatic, and renal function, as defined in the protocol

- At least 4 weeks and recovery from effects of prior surgery or other therapy,
including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy,
with an approved or investigational agent

- Ability to swallow an oral solid-dosage form of medication

Primary exclusion criteria:

- Nonmeasurable disease only (revised RECIST; Version 1.1)

- History or presence of brain metastasis or leptomeningeal disease

- Operable gastric cancer or operable cancer of the esophagogastric junction

- Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the
patient's usual number of bowel movements on at least 2 days within the 14 days prior
to enrollment

- Uncontrolled nausea or vomiting within the 14 days prior to enrollment despite the
administration of standard antiemetic therapy

- Known malabsorptive disorder

- Significant medical disease other than cancer, as defined in the protocol

- Presence of neuropathy > Grade 1 (National Cancer Institute Common Toxicity Criteria
[NCI CTC]; Version 4.0)

- Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other
than a vinca alkaloid

- Need to continue any regularly-taken medication that is a potent inhibitor or inducer
of the CYP3A pathway or P-glycoprotein activity

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (Response Evaluation Criteria In Solid Tumors (RECIST))

Outcome Time Frame:

12 months from date of first dose of study medication

Safety Issue:

No

Principal Investigator

Jaffer Ajani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The University of Texas MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

TOG201

NCT ID:

NCT01095120

Start Date:

March 2010

Completion Date:

October 2012

Related Keywords:

  • Adenocarcinoma of the Stomach
  • Adenocarcinoma of Esophagogastric Junction
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

Name

Location

Northwestern Medical Faculty FoundationChicago, Illinois  60611
Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced MedicinePhiladelphia, Pennsylvania  19104
The University of Texax MD Anderson Cancer CenterHouston, Texas  77030