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Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00615940
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : February 28, 2014
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Heidelberg Pharma AG

Brief Summary:
This randomized, double-blind, placebo controlled phase II trial is studying how well capecitabine works when given in combination with WX-671 or when given alone in treating patients receiving first-line therapy for her2negative metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: WX-671 Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Two-arm, Double-blind, Multi-center, Randomized Study of the Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer
Study Start Date : July 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 1
Capecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with WX-671 once daily by mouth, Days 1-21 inclusive.
Drug: WX-671
capsules taken per os once daily until progression or toxicity

Experimental: 2
Capecitabine, 1000 mg/m2, twice daily by mouth, on Days 1 to 14, followed by a 7 day rest in each 21 day cycle given in combination with placebo once daily by mouth, Days 1-21 inclusive.
Drug: placebo
capsule taken per os once daily until progression or toxicity




Primary Outcome Measures :
  1. Efficacy in terms of progression-free survival (PFS) [ Time Frame: disease staging with CT/MRI/bone scans at regular intervals ]

Secondary Outcome Measures :
  1. Secondary endpoints are objective response rate (ORR), overall survival, safety and pharmacokinetics. [ Time Frame: 2 years ]


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.


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

Inclusion Criteria:

  • Females aged ≥ 18 years
  • Patients appropriate for palliative first-line, mono chemotherapy with capecitabine
  • Histological or cytological confirmed, non-inflammatory metastatic breast cancer
  • Availability of paraffin-embedded tumor tissue from the primary resection or biopsy of a metastatic lesion.
  • HER2-negative breast cancer
  • Complete staging within 2 weeks prior to randomization (4 weeks for bone scan).
  • Radiologically confirmed disease
  • ECOG performance status of ≤ 2
  • Ability to understand and willingness to voluntarily sign and date a written informed consent form before screening
  • Negative pregnancy test (urine or serum) within 3 days before first study drug for women of childbearing potential. Use of effective contraception during the study and for 3 months after stopping study drug treatment.
  • Normal organ and marrow function as defined by laboratory parameters (obtained within the screening period) within the following limits:

    • neutrophils >= 1.5 x 109/L;
    • platelets >= 100 x 109/L;
    • hemoglobin >= 9.0 g/dL (5.6 mmol/L).
    • total bilirubin <= 1.5 x upper limit of normal (ULN);
    • aspartate aminotransferase (AST)/ALT <= 2.5 x ULN (< 5.0 x ULN for patients with liver metastases);
    • serum creatinine <= 2 x ULN, or calculated creatinine clearance >45 mL/min according to Cockroft and Gault formula).

Exclusion Criteria:

  • Endocrine therapy completed within 2 weeks before the start of treatment (i.e. previous hormone therapy is allowed provided that there is a washout period of 2 weeks).
  • Prior chemotherapy or biologic therapy for metastatic disease.
  • Major surgery within 4 weeks prior to the start of treatment.
  • Other anti-cancer treatment (e.g. hormones) within 2 weeks before the start of treatment.
  • Treatment within 12 months with adjuvant 5-FU containing chemotherapy (regarded as indicating 5-FU resistance) and/or prior capecitabine therapy.
  • Radiation therapy. Palliative radiation of stable, non-target lesions more than 2 weeks before the start of treatment is allowed, provided patients have recovered from the radiation side-effects.
  • History of or radiological evidence of brain metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
  • Active seizure disorder or history of cerebrovascular accident (CVA) or transient ischemic (TI) attack within the past 12 months.
  • History of other malignancy within the last 3 years except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
  • Active cardiac disease e.g. unstable angina, congestive heart failure, myocardial infarction (MI) within the preceding 6 months.
  • Any medical condition prohibiting standard imaging procedures
  • Pregnant or breast-feeding.
  • Any unrelated illness, e.g. active infection requiring parenteral antibiotics, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator might significantly affect patients' study participation.
  • Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of either study drug.
  • Known hepatitis B/C or HIV (human immunodeficiency virus) infection.

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 ClinicalTrials.gov identifier (NCT number): NCT00615940


Locations
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Sponsors and Collaborators
Heidelberg Pharma AG
U.S. Army Medical Research and Development Command
Investigators
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Principal Investigator: Lori Goldstein, MD Dept. of Medical Oncology, Division of Medical Science, Fox Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania 19111, USA
Principal Investigator: Nadia Harbeck, MD Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln
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Responsible Party: Heidelberg Pharma AG
ClinicalTrials.gov Identifier: NCT00615940    
Other Study ID Numbers: WX/60-006
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: January 2014
Keywords provided by Heidelberg Pharma AG:
HER2negative
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases