Clinical trial NCT01095120: Tesetaxel as Second-line Therapy for Patients With Advanced Gastric Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Adenocarcinoma of the Stomach
Adenocarcinoma of Esophagogastric Junction
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2010-03-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced gastric cancer.


Eligibility 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

Primary outcomes:
measure: Response rate (Response Evaluation Criteria In Solid Tumors (RECIST))
timeFrame: 12 months from date of first dose of study medication
Secondary outcomes:
measure: Disease control rate (ie, the percentage of patients with a confirmed complete or partial response [of any duration] or stable disease at least 6 weeks in duration)
timeFrame: 12 months from date of first dose of study medication
measure: Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)
timeFrame: 12 months from date of first dose of study medication
measure: Duration of response
timeFrame: 12 months from date of first dose of study medication
measure: Adverse events
timeFrame: Through 30 days post last dose of study medication
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation
state: Illinois
city: Philadelphia
country: United States
facility: Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced Medicine
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texax MD Anderson Cancer Center
state: Texas
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Jaffer Ajani, MD
role: STUDY_CHAIR
References: