DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
Tracking Information | |||||
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First Received Date ICMJE | April 7, 2004 | ||||
Last Updated Date | May 15, 2012 | ||||
Start Date ICMJE | February 2004 | ||||
Primary Completion Date | August 2006 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00080834 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma | ||||
Official Title ICMJE | A Phase II Study Of Oral DJ-927 Administered As A Single Dose Every Three Weeks To Patients With Advanced Or Metastatic Adenocarcinoma Of The Colon Or Rectum | ||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as DJ-927, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well DJ-927 works as second-line therapy in treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma (cancer). |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior first-line treatment regimen (irinotecan-containing vs oxaliplatin-containing). Patients receive oral DJ-927* on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: *Patients receive 1 of 2 selected doses to confirm the previously established maximum tolerated dose Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 56-62 patients (28-31 per stratum) will be accrued for this study within 12 months. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Cancer | ||||
Intervention ICMJE | Drug: DJ-927 | ||||
Study Arm (s) | |||||
Publications * | Rhee JM, Lee FC, Saif MW, et al.: Phase II trial of DJ-927 as a second-line treatment for colorectal cancer demonstrates objective responses. [Abstract] J Clin Oncol 23 (Suppl 16): A-3654, 284s, 2005. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | |||||
Completion Date | August 2006 | ||||
Primary Completion Date | August 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00080834 | ||||
Other Study ID Numbers ICMJE | CDR0000356034, DAIICHI-927A-PRT004, MDA-2003-0749 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Daiichi Sankyo Inc. | ||||
Study Sponsor ICMJE | Daiichi Sankyo Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Daiichi Sankyo Inc. | ||||
Verification Date | May 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |