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CancerPhase 2NCT01128543

Lapatinib in Combination With Vinorelbine

A Phase 2 study testing lapatinib and Vinorelbine in people with Cancer, run by GlaxoSmithKline at 8 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Multicenter, Open-Label, Phase II Study of lapatinib in Combination with Vinorelbine in women with documented evidence of HER2/neu positive breast cancer which is metastatic or recurrent and with or without prior chemotherapy or anti-HER2/neu targeted therapy in the metastatic and relaps setting. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cancer
What is being tested?
lapatinib and Vinorelbine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
8 sitesTurkey (Türkiye)
Study dates
Apr 2009to Mar 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the breast.
  • Patients must be > 18 years of age
  • Metastatic breast cancer (stage IV) at primary diagnosis or at relapse after curative intent therapy.
  • Laboratory confirmed HER2/neu overexpressing and/or amplified disease in the invasive component of the primary or metastatic lesion
  • Patients must have evidence of metastatic disease, but measurable disease is not mandatory.
  • The patients may have received or not prior treatment with chemotherapeutic agents including taxanes, trastuzumab or anthracycline in the adjuvant or metastatic setting is permitted.
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  • Prior treatments with radiation therapy in the adjuvant and/or metastatic setting are permitted provided that at least 4 weeks have elapsed since the last fraction of radiation therapy and all treatment related adverse events are < grade 1 at the time of enrollment.
  • Prior radiation to a solitary metastatic lesion is permitted provided that progression post radiation has been documented.
  • Patients must have life expectancy > 3 months.
  • ECOG performance status 0, 1 or 2 (see Appendix II).
  • Patients must have normal organ and marrow function measured within 14 days prior to enrollment as defined Table 1.
  • Left ventricular ejection fraction > 50% as demonstrated by MUGA scan/echocardiogram within 4 weeks prior to enrollment.
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to enrollment and must use an acceptable method of contraception for the duration of the study.
  • Female patients who are lactating should discontinue nursing prior to the first dose of investigational product and should refrain from nursing throughout the treatment period and for 14 days following the last dose of investigational product.
  • The patient must sign the consent form prior to enrollment.
  • Patients must be accessible for treatment and follow-up.

Who cannot join

  • Patients with a history of other malignancies, except: adequately treated DCIS, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours (non-breast) curatively treated with no evidence of disease for > 5 years.
  • Patients receiving ongoing anticancer treatment or other investigational anti-cancer agents for breast cancer or patients who have used an investigational drug within 30 days or 5 half-lives (if known), whichever is longer, preceding the date of enrollment.
  • Patients with symptomatic CNS metastases (including leptomeningeal involvement).
  • Patients with only bone metastasis.
  • Patients with serious cardiac illness or condition including, but not limited to:
  • history of documented congestive heart failure (CHF) or systolic dysfunction (LVEF<50%) high risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled) unstable angina pectoris requiring anti-anginal medication clinically significant valvular heart disease evidence of transmural infarction on ECG inadequately controlled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg).
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  • New York Heart Association (NYHA) Class III or IV functional status (see Appendix X)
  • Patients who have received vinorelbine as a prior therapy in the metastatic and recurrent setting.
  • Patients with serious illness or medical condition which would not permit the patient to be managed according to the protocol including, but not limited to:
  • History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.
  • Active uncontrolled infection. Serious or non-healing wound, ulcer, or bone fracture.
  • Patients with GI tract disease resulting in an inability to take oral medication such as but not limited to malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption (for example resection of stomach or small bowel) or uncontrolled inflammatory GI disease (e.g. Crohn's, ulcerative colitis).
  • Patients receiving CYP3A4 inhibitors or inducers are not eligible unless it has been > 7 and > 14 days, respectively since the last dose of medication before the start of protocol treatment (see Appendix IX). For amiodarone in particular, dosing is prohibited for at least 6 months prior to the start of protocol treatment.
  • Patients with history of allergic or hypersensitivity reactions to any study drug or their excipients or with a history of allergic reactions attributed to compounds with similar chemical composition to any of the study drugs.
  • Pregnant or lactation women

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Turkey (Türkiye)8 sites

  • GSK Investigational Site

    Ankara, 06100

  • GSK Investigational Site

    Ankara, 06500

  • GSK Investigational Site

    Ankara, 06590

  • GSK Investigational Site

    Diskapi / Ankara, 337088

  • GSK Investigational Site

    Diyarbakır, 21280

  • GSK Investigational Site

    Istanbul, 34390

  • GSK Investigational Site

    Istanbul, 34668

  • GSK Investigational Site

    Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: A Multicenter, Open-Label, Phase II Study of Lapatinib in Combination With Vinorelbine in Subjects With ErbB2 Amplified Recurrent and Metastatic Breast Cancer

This is a Multicenter, Open-Label, Phase II Study of lapatinib in Combination with Vinorelbine in women with documented evidence of HER2/neu positive breast cancer which is metastatic or recurrent and with or without prior chemotherapy or anti-HER2/neu targeted therapy in the metastatic and relaps setting.

Read the detailed description

This is a Multicenter, Open-Label, Phase II Study of lapatinib in Combination with Vinorelbine in women with documented evidence of HER2/neu positive breast cancer which is metastatic or recurrent and with or without prior chemotherapy or anti-HER2/neu targeted therapy in the metastatic and relaps setting.

Patients will receive 1250mg lapatinib once a day and vinorelbine 25mg/sqm IV Day 1and Day 8, every 3 week for 24 weeks. The study treatment will continue until patients experience disease progression or unacceptable toxicity. The primary objective of the study is the objective response rate (ORR, defined as CR + PR) and toxicity. Secondary objectives include DFS, duration of response.

Conditions
Cancer
Being tested
lapatinib and Vinorelbine
Keywords
lapatinib, breast cancer
Medical subject headings
Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lapatinib and VinorelbineDrug

    Patients will receive 1250mg lapatinib once a day and vinorelbine 25mg/sqm IV Day 1and Day 8, every 3 week for 24 weeks.

Study groups in NCT01128543
Study groupRoleWhat they receive
lapatinib 1250mgActive comparatorPatients will receive 1250mg lapatinib once a day for 24 weeks.
Receives: Drug: lapatinib and Vinorelbine
Vinorelbine 25mg/sqmActive comparatorPatients will receive vinorelbine 25mg/sqm IV Day 1 and Day 8, every 3 week for 24 weeks.
Receives: Drug: lapatinib and Vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24

    Par. with CB are defined as those with complete response (CR), partial response (PR), or stable disease (SD) for >=12 or 24 weeks. Per Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1, CR is defined as the disappearance of all target lesions, PR is defined as a >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as a reference the smallest sum LD since the treatment started.

    Measured: Week 12 and Week 24

Secondary outcomes (2)

  1. Progression-free Survival

    Per RECIST, Version 1.1, Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: From the start of treatment until disease progression, death, or discontinuation from the study (average of 102.7 months)

  2. Duration of Response

    Duration of response was measured in participants who experienced either a complete response or a partial response. Per RECIST, Version 1.1, complete response is defined as the disappearance of all target lesions, and partial response is defined as a >=30% decrease in the sum of the longest diameter of target lesions, taking as a reference the baseline sum longest diameter.

    Measured: From the start of treatment until a complete response or partial response was reached (up to Week 90; average of 21.3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01128543
Sponsor's protocol ID
112564
Status last verified
Nov 2012
First submitted
20 May 2010
Last updated
12 Dec 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lapatinib and Vinorelbine in people with Cancer, run by GlaxoSmithKline at 8 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24 (time frame: Week 12 and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01128543.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.

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