Neoplasms, BreastPhase 1NCT00790816
Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents
A Phase 1 study testing Lapatinib in combination with an anti-cancer agent, Lapatinib and Lapatinib in combination with an anti-cancer agent as specified by parent protocol in people with Neoplasms, Breast, run by Novartis Pharmaceuticals at 23 sites in 5 countries.
Trial summary
This study is designed to provide continued access to lapatinib as monotherapy or as part of a combination regimen to cancer subjects who are currently participating in a phase I trial that has met its study objectives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Breast
- What is being tested?
- Lapatinib in combination with an anti-cancer agent, Lapatinib and Lapatinib in combination with an anti-cancer agent as specified by parent protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 23 sitesin 5 countries
- Study dates
- Oct 2008to 19 Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in a Phase I lapatinib trial that has met its study objectives.
- Ability to understand and provide written informed consent to participate in this study.
- Male or female greater than or equal to 18 years of age.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods stated in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least two to four weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Child-bearing potential, has a negative serum pregnancy test at baseline, and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception from two weeks prior to the administration of study drug and throughout the entire active study treatment period until four weeks after the last dose of study medication.
Who cannot join
- Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
- Is a pregnant or lactating female.
- Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or baseline investigations.
- Currently receiving treatment with any medications listed on the prohibited medication listed in the protocol
- Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Have current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
United States15 sites
Novartis Investigative Site
Atlanta, Georgia, 30341
Novartis Investigative Site
Buffalo, New York, 14263
Novartis Investigative Site
Cleveland, Ohio, 44106
Novartis Investigative Site
Detroit, Michigan, 48202
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Fort Myers, Florida, 33916
Novartis Investigative Site
Greenville, South Carolina, 29605
Novartis Investigative Site
Lebanon, New Hampshire, 03756
Novartis Investigative Site
Memphis, Tennessee, 38120
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
Salt Lake City, Utah, 84112
Novartis Investigative Site
Santa Monica, California, 90404
Novartis Investigative Site
Scottsdale, Arizona, 85259
Novartis Investigative Site
Tucson, Arizona, 85724
Novartis Investigative Site
Washington D.C., District of Columbia, 20007
South Korea4 sites
Novartis Investigative Site
Seoul, 110-744
Novartis Investigative Site
Seoul, 120-752
Novartis Investigative Site
Seoul, 135-710
Novartis Investigative Site
Songpa-gu, Seoul, 138-736
Canada2 sites
Novartis Investigative Site
Edmonton, Alberta, T6G 1Z2
Novartis Investigative Site
Montreal, Quebec, H2W 1T8
Spain1 site
Novartis Investigative Site
Hospitalet de Llobregat (Barcelona), 08907
About this study
Official title: An Open-Label Phase Ib Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-Cancer Treatment in Patients With Solid Tumors
This study is designed to provide continued access to lapatinib as monotherapy or as part of a combination regimen to cancer subjects who are currently participating in a phase I trial that has met its study objectives.
- Conditions
- Neoplasms, Breast
- Being tested
- Lapatinib in combination with an anti-cancer agent, Lapatinib, Lapatinib in combination with an anti-cancer agent as specified by parent protocol
- Keywords
- Cancer, lapatinib, Combination therapy, Chronic administration
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lapatinib in combination with an anti-cancer agentDrug
Lapatinib in combination with paclitaxel, letrozole, capecitabine, capecitabine/oxaliplatin, gemcitabine, docetaxel, trastuzumab, FOLFOX4, or FOLFIRI
LapatinibDrug
Lapatinib monotherapy
Lapatinib in combination with an anti-cancer agent as specified by parent protocolDrug
Lapatinib in combination with an anti-cancer agent as specified by parent protocol
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Study Drug Receives: Drug: Lapatinib; Drug: Lapatinib in combination with an anti-cancer agent as specified by parent protocol |
| Group 2 | Experimental | Study Drug Receives: Drug: Lapatinib in combination with an anti-cancer agent; Drug: Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: Initiation of study treatment to discontinuation of study treatment
Secondary outcomes (1)
Efficacy
Measured: Initiation of study treatment to discontinuation of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startOct 2008
- Primary completion19 Aug 2016
- Study completion19 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, BreastStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790816
- Sponsor's protocol ID
- 111767
- Status last verified
- Feb 2018
- First submitted
- 13 Nov 2008
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase Ib Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-Cancer Treatment in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00790816
- Acronym / sponsor ID
- 111767
- Conditions
- Neoplasms, Breast
- Keywords
- Cancer, lapatinib, Combination therapy, Chronic administration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- 19 Aug 2016 (actual)
- Study completion
- 19 Aug 2016 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to provide continued access to lapatinib as monotherapy or as part of a combination regimen to cancer subjects who are currently participating in a phase I trial that has met its study objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Lapatinib, Drug: Lapatinib in combination with an anti-cancer agent as specified by parent protocolStudy Drug |
| Group 2 | Experimental | Drug: Lapatinib in combination with an anti-cancer agent, Drug: LapatinibStudy Drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participation in a Phase I lapatinib trial that has met its study objectives.
- Ability to understand and provide written informed consent to participate in this study.
- Male or female greater than or equal to 18 years of age.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods stated in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least two to four weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
Key exclusion criteria (6 listed)
- Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
- Is a pregnant or lactating female.
- Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or baseline investigations.
- Currently receiving treatment with any medications listed on the prohibited medication listed in the protocol
- Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lapatinib in combination with an anti-cancer agentLapatinib in combination with paclitaxel, letrozole, capecitabine, capecitabine/oxaliplatin, gemcitabine, docetaxel, trastuzumab, FOLFOX4, or FOLFIRI | Drug | Group 2 |
| LapatinibLapatinib monotherapy | Drug | Group 1, Group 2 |
| Lapatinib in combination with an anti-cancer agent as specified by parent protocolLapatinib in combination with an anti-cancer agent as specified by parent protocol | Drug | Group 1 |
Primary outcome
Safety and tolerability
Time frame: Initiation of study treatment to discontinuation of study treatment
1 secondary outcome
Efficacy
Time frame: Initiation of study treatment to discontinuation of study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lapatinib in combination with an anti-cancer agent, Lapatinib and Lapatinib in combination with an anti-cancer agent as specified by parent protocol in people with Neoplasms, Breast, run by Novartis Pharmaceuticals at 23 sites in 5 countries.
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 6 inclusion and 6 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, South Korea, Canada, Netherlands, Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability (time frame: Initiation of study treatment to discontinuation of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2018.