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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by (Responsible Party): | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01013740 |
Purpose
This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic setting.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms, Breast Cancer |
Drug: Vinorelbine Drug: Lapatinib Drug: Capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Randomised, Multi-Centre Study Evaluating Lapatinib in Combination With Vinorelbine or Capecitabine in Women With ErbB2 Overexpressing Metastatic Breast Cancer |
| Enrollment: | 105 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lapatinib + Vinorelbine |
Drug: Vinorelbine
Vinorelbine
Drug: Lapatinib
Lapatinib
|
| Active Comparator: Lapatinib + Capecitabine |
Drug: Lapatinib
Lapatinib
Drug: Capecitabine
Capecitabine
|
Approximately 105 subjects will be enrolled in the study and randomized 2:1 to one of the following regimens Arm A (n=70): Lapatinib 1250 mg orally once daily continuously plus Vinorelbine 20mg/m2 intravenously (IV) on day 1 and 8, every third week, or Arm B (n=35): Lapatinib 1250 mg orally once daily (QD) continuously plus Capecitabine 2000 mg/m2/day orally in 2 doses 12 hours apart on days 1-14 every third week. Randomization will be stratified according to the following variables: 1) Prior receipt of therapy for metastatic breast cancer (Yes or No), and 2) Site of metastatic disease (Visceral/Soft tissue or Bone-only). Subjects will receive randomized study treatment until disease progression or discontinuation of study treatment due to unacceptable toxicity, withdrawal of consent, lost to follow up, or death. All subjects who discontinue study treatment without documented progression will continue to be followed for progression according to protocol-schedule until new anti-cancer therapy is initiated and/or progression or death is documented. Survival data will be collected for all subjects to ensure a minimum of 18 months survival data. This study will include a safety run-in phase for approximately the first 30 subjects (20 randomized to lapatinib and vinorelbine; 10 to lapatinib and capecitabine).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria :
Exclusion Criteria:
Contacts and Locations
Show 50 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01013740 History of Changes |
| Other Study ID Numbers: | 112620 |
| Study First Received: | October 29, 2009 |
| Last Updated: | May 17, 2012 |
| Health Authority: | Spain: Agencia Española del Medicamento y Productos Sanitarios Italy: Isituto Superiore di Sanita' Poland: Centralna Ewidencja Badań Klinicznych Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Germany: Bundesinstitut für Arzneimittel und Medizinprodukte France: Agence Française de Sécurité Sanitaire des Produits de Santé Greece: National Drug Organisation |
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Vinorelbine Vinblastine Capecitabine Lapatinib Fluorouracil Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors |