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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

Tracking Information
First Submitted Date  ICMJE February 1, 2008
First Posted Date  ICMJE February 14, 2008
Last Update Posted Date February 28, 2014
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
Efficacy in terms of progression-free survival (PFS) [ Time Frame: disease staging with CT/MRI/bone scans at regular intervals ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2008)
Secondary endpoints are objective response rate (ORR), overall survival, safety and pharmacokinetics. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: WX-671
    capsules taken per os once daily until progression or toxicity
  • Drug: placebo
    capsule taken per os once daily until progression or toxicity
Study Arms  ICMJE
  • 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.
    Intervention: Drug: WX-671
  • 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.
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2012)
132
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2008)
100
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Germany,   Israel,   United States
Removed Location Countries Ukraine
 
Administrative Information
NCT Number  ICMJE NCT00615940
Other Study ID Numbers  ICMJE WX/60-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Heidelberg Pharma AG
Original Responsible Party Dr. Carola Mala, Wilex
Current Study Sponsor  ICMJE Heidelberg Pharma AG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE U.S. Army Medical Research and Development Command
Investigators  ICMJE
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
PRS Account Heidelberg Pharma AG
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP