Know Cancer

forgot password

A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer

Phase 1/Phase 2
20 Years
Open (Enrolling)
Gastric Carcinoma

Thank you

Trial Information

A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer


Inclusion Criteria:

- At least 20 years of age

- Histologically or cytologically confirmed gastric carcinoma, including gastric or
gastroesophageal-junction adenocarcinoma.

- Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable

- Previously untreated, unresectable advanced (M0) or unresectable metastatic (M1)
disease except for prior adjuvant (or neo-adjuvant) chemotherapy.

- ECOG performance status 0 or 1

- At least 4 weeks and recovery from effects of prior major surgery

- Adequate bone marrow, hepatic, and renal function

Primary Exclusion Criteria:

- Operable gastric or gastroesophageal-junction cancer

- Known brain metastasis

- Second cancer

- Previous adjuvant or neo-adjuvant chemotherapy with capecitabine and cisplatin in
combination. (Previous adjuvant or neo-adjuvant monotherapy with capecitabine or S-1
or therapy with S-1 and cisplatin in combination or 5-FU and cisplatin in combination
is allowed.)

- Uncontrolled diarrhea

- Nausea or vomiting for at least 3 consecutive days within the 14 days prior to
registration despite the administration of standard antiemetic therapy

- Symptomatic peripheral neuropathy ≥ Grade 2

- Malabsorption syndrome or other disease that significantly affects gastrointestinal

- Other uncontrolled systemic illness

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival rate (in Phase 2 portion of study)

Outcome Time Frame:

6 months from the date of first dose of study medication

Safety Issue:


Principal Investigator

Sun Young Rha, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yonsei Cancer Center, Yonsei University College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

January 2014

Related Keywords:

  • Gastric Carcinoma
  • Gastric cancer
  • First-line therapy
  • Tesetaxel
  • Taxane
  • Capecitabine
  • Oral fluoropyrimidine
  • Cisplatin
  • Platinum
  • Carcinoma
  • Stomach Neoplasms