DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077077
Recruitment Status : Completed
First Posted : February 11, 2004
Last Update Posted : May 16, 2012
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as DJ-927 and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of DJ-927 and capecitabine in treating patients with locally advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: DJ-927 Drug: capecitabine Phase 1

Detailed Description:



  • Determine the maximum tolerated dose of DJ-927 and capecitabine in patients with locally advanced or metastatic solid tumors.
  • Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients.


  • Determine the toxicity profile of this regimen in these patients.
  • Determine the possible pharmacokinetic interactions of this regimen in these patients.
  • Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is an open-label, dose-escalation, nonrandomized, multicenter study.

  • Course 1: Patients receive oral DJ-927 once on day 1 and oral capecitabine once on days 0 and 1 and twice daily on days 2-14.
  • Course 2: Patients receive DJ-927 as in course 1 and oral capecitabine twice daily on days 2-15.
  • Course 3 and all subsequent courses: Patients receive DJ-927 as in course 1 and oral capecitabine twice daily on days 1-14.

All courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of DJ-927 and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients receive treatment at the MTD.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 18 months.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors
Study Start Date : February 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed solid tumor

    • Locally advanced or metastatic disease
  • Minimally pretreated
  • No symptomatic brain metastases



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • Bilirubin no greater than 1.5 times ULN


  • Creatinine no greater than 1.5 times ULN


  • No prior chronic diarrhea
  • No swallowing and/or malabsorption problems
  • No diarrhea (excess of 2-3 stools/day above normal frequency in the past month)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No prior severe or life-threatening hypersensitivity reaction to a taxane or capecitabine
  • No concurrent serious infection
  • No neuropathy grade 2 or greater
  • No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other severe or uncontrolled underlying medical disease that would preclude study participation
  • No psychiatric disorder that would preclude giving informed consent or study compliance


Biologic therapy

  • No concurrent anticancer biologic therapy


  • Recovered from prior chemotherapy
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Not specified


  • Recovered from prior radiotherapy
  • No concurrent anticancer radiotherapy

    • Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective


  • At least 4 weeks since prior major surgery and recovered
  • No prior major surgery in the stomach or small intestine


  • At least 4 weeks since prior myelosuppressive therapy
  • More than 28 days since prior investigational drugs (including analgesics and/or antiemetics)
  • No other concurrent anticancer therapy
  • No other concurrent anticancer cytotoxic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077077

United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Daiichi Sankyo, Inc.
OverallOfficial: Chris H. Takimoto, MD, PhD, FACP Cancer Therapy and Research Center, Texas

Publications of Results:
Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00077077     History of Changes
Other Study ID Numbers: CDR0000346368
First Posted: February 11, 2004    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012

Keywords provided by Daiichi Sankyo, Inc.:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents