CancerPhase 1NCT01231594
A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
A Phase 1 study testing GSK2118436, GSK1120212 and Other approved anti-cancer agent in people with Cancer, run by Novartis Pharmaceuticals at 44 sites in 9 countries.
Trial summary
This rollover study is designed to provide continued access to GSK2118436 for eligible subjects with BRAF mutation-positive tumors who have previously participated in a GlaxoSmithKline (GSK)-sponsored GSK2118436 study (parent study), who have no evidence of progressive disease and who have tolerated GSK2118436 in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- GSK2118436, GSK1120212 and Other approved anti-cancer agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 44 sitesin 9 countries
- Study dates
- 5 Nov 2010to 9 Apr 2018
- 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
- Has provided signed written informed consent for this study
- Has demonstrated compliance with study drug(s), treatment visit schedules, and the requirements and restrictions listed in the consent form
- Is currently participating in a GSK-sponsored study of GSK2118436
- Currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with GSK2118436 (either as monotherapy or as part of a combination treatment regimen)
- For Cohort C only: Subjects must have a calcium phosphate product (CPP) of <4.4 mmol^2/L^2 (55 mg^2/dL^2) if they are to continue treatment with GSK1120212
- Continued ability to swallow and retain orally administered study drug(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
Show all 9Show fewer
- Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study NOTE: Oral contraceptives are not reliable due to potential drug-drug interaction with GSK2118436
- Women of childbearing potential must have a negative serum pregnancy test at the time of transition to this study and before the first dose of study treatment
- French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
Who cannot join
- Permanent discontinuation of GSK2118436 in the parent study due to toxicity or disease progression
- Local access to commercially available GSK2118436
- Currently receiving treatment with any prohibited medication(s)
- Any unresolved toxicity > Grade 2 (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment, except for alopecia, will need to be approved by the GSK Medical Monitor
- Uncontrolled diabetes, hypertension or other medical conditions at the time of transition to this study that may interfere with assessment of toxicity
- Presence of rheumatoid arthritis
Show all 11Show fewer
- Corrected QT (QTc) interval >/= 480 msec at the time of transition to this study
- Left ventricular ejection fraction (LVEF) </= institutional lower limit of normal (LLN) by ECHO at the time of transition to this study
- Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system at the time of transition to this study
- Pregnant or lactating female
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor
Trial locations and contacts
44 sites in 9 countries.
44 sites in 9 countries
United States25 sites
Novartis Investigative Site
Ann Arbor, Michigan, 48109
Novartis Investigative Site
Columbus, Ohio, 43210
Novartis Investigative Site
Dallas, Texas, 75246
Novartis Investigative Site
Detroit, Michigan, 48201
Novartis Investigative Site
Goodyear, Arizona, 85338
Novartis Investigative Site
Greenville, South Carolina, 29605
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Lebanon, New Hampshire, 03756
Novartis Investigative Site
Los Angeles, California, 90025
Novartis Investigative Site
Los Angeles, California, 90095-7059
Novartis Investigative Site
Memphis, Tennessee, 38120
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
Nashville, Tennessee, 37232-5536
Novartis Investigative Site
New York, New York, 10016
Novartis Investigative Site
New York, New York, 10065
Novartis Investigative Site
Oklahoma City, Oklahoma, 73104
Novartis Investigative Site
Philadelphia, Pennsylvania, 19111
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15232
Novartis Investigative Site
Salt Lake City, Utah, 84112
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
San Francisco, California, 94115
Novartis Investigative Site
Sarasota, Florida, 34232
Novartis Investigative Site
Scottsdale, Arizona, 85259
Novartis Investigative Site
Tacoma, Washington, 98405
Novartis Investigative Site
Tucson, Arizona, 85724-5024
Australia6 sites
Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Heidelberg, Victoria, 3084
Novartis Investigative Site
Melbourne, Victoria, 3004
Novartis Investigative Site
Nedlands, Western Australia, 6009
Novartis Investigative Site
Randwick, New South Wales, 2031
Novartis Investigative Site
Westmead, New South Wales, 2145
Germany3 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Essen, North Rhine-Westphalia, 45122
Novartis Investigative Site
Lübeck, Schleswig-Holstein, 23538
Spain3 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Seville, 41013
Poland2 sites
Novartis Investigative Site
Konin, 62-500
Novartis Investigative Site
Warsaw, 02-781
United Kingdom2 sites
Novartis Investigative Site
Headington, OX3 7LJ
Novartis Investigative Site
London, W1G 6AD
About this study
This rollover study is designed to provide continued access to GSK2118436 for eligible subjects with BRAF mutation-positive tumors who have previously participated in a GlaxoSmithKline (GSK)-sponsored GSK2118436 study (parent study), who have no evidence of progressive disease and who have tolerated GSK2118436 in the parent study without significant toxicities. Subjects will be enrolled into the appropriate cohort based upon the treatment received in their parent study. Safety assessments (physical examinations, vital signs, 12-lead electrocardiograms, echocardiograms, clinical laboratory assessments, and monitoring of adverse events) will be made throughout the study. Clinical activity will be assessed using local standard of care imaging practices and the appropriate response criteria as determined by the investigator.
- Conditions
- Cancer
- Being tested
- GSK2118436, GSK1120212, Other approved anti-cancer agent
- Keywords
- BRAF Inhibitor, Cancer, Safety, GSK2118436, BRAF mutation positive tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2118436Drug
Study Drug
GSK1120212Drug
Study Drug
Other approved anti-cancer agentDrug
Study Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Subjects who have received </= 8 weeks of GSK2118436 monotherapy in the parent study Receives: Drug: GSK2118436 |
| Cohort B | Experimental | Subjects who have received >8 weeks of continuous treatment with GSK2118436 either as monotherapy or combination therapy with another approved anti-cancer agent Receives: Drug: GSK2118436; Drug: Other approved anti-cancer agent |
| Cohort C | Experimental | Subjects who have received >8 weeks of continuous treatment with GSK2118436 in combination with a MEK inhibitor, GSK1120212 Receives: Drug: GSK2118436; Drug: GSK1120212 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events, as a measure of safety and tolerability
Measured: From date of transition into this Rollover study until 28 days following the last dose. Subjects may continue to receive study medication until disease progression, death or unacceptable adverse event; there is no time limit for this outcome measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study start5 Nov 2010
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 214 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
- NCT01231594
- Sponsor's protocol ID
- 114144
- Status last verified
- Mar 2019
- First submitted
- 21 Oct 2010
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
- ClinicalTrials.gov ID
- NCT01231594
- Acronym / sponsor ID
- 114144
- Conditions
- Cancer
- Keywords
- BRAF Inhibitor, Cancer, Safety, GSK2118436, BRAF mutation positive tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2010 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 1 Nov 2010 (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 rollover study is designed to provide continued access to GSK2118436 for eligible subjects with BRAF mutation-positive tumors who have previously participated in a GlaxoSmithKline (GSK)-sponsored GSK2118436 study (parent study), who have no evidence of progressive disease and who have tolerated GSK2118436 in the parent study without significant toxicities. Subjects will be enrolled into the appropriate cohort based upon the treatment received in their parent study. Safety assessments (physical examinations, vital signs, 12-lead electrocardiograms, echocardiograms, clinical laboratory assessments, and monitoring of adverse events) will be made throughout the study. Clinical activity will be assessed using local standard of care imaging practices and the appropriate response criteria as determined by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: GSK2118436Subjects who have received </= 8 weeks of GSK2118436 monotherapy in the parent study |
| Cohort B | Experimental | Drug: GSK2118436, Drug: Other approved anti-cancer agentSubjects who have received >8 weeks of continuous treatment with GSK2118436 either as monotherapy or combination therapy with another approved anti-cancer agent |
| Cohort C | Experimental | Drug: GSK2118436, Drug: GSK1120212Subjects who have received >8 weeks of continuous treatment with GSK2118436 in combination with a MEK inhibitor, GSK1120212 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has provided signed written informed consent for this study
- Has demonstrated compliance with study drug(s), treatment visit schedules, and the requirements and restrictions listed in the consent form
- Is currently participating in a GSK-sponsored study of GSK2118436
- Currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with GSK2118436 (either as monotherapy or as part of a combination treatment regimen)
- For Cohort C only: Subjects must have a calcium phosphate product (CPP) of <4.4 mmol^2/L^2 (55 mg^2/dL^2) if they are to continue treatment with GSK1120212
Key exclusion criteria (11 listed)
- Permanent discontinuation of GSK2118436 in the parent study due to toxicity or disease progression
- Local access to commercially available GSK2118436
- Currently receiving treatment with any prohibited medication(s)
- Any unresolved toxicity > Grade 2 (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment, except for alopecia, will need to be approved by the GSK Medical Monitor
- Uncontrolled diabetes, hypertension or other medical conditions at the time of transition to this study that may interfere with assessment of toxicity
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 |
|---|---|---|
| GSK2118436Study Drug | Drug | Cohort A, Cohort B, Cohort C |
| GSK1120212Study Drug | Drug | Cohort C |
| Other approved anti-cancer agentStudy Drug | Drug | Cohort B |
Primary outcome
Number of participants with adverse events, as a measure of safety and tolerability
Time frame: From date of transition into this Rollover study until 28 days following the last dose. Subjects may continue to receive study medication until disease progression, death or unacceptable adverse event; there is no time limit for this outcome measure.
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 22 Mar 2019.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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
44 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK2118436, GSK1120212 and Other approved anti-cancer agent in people with Cancer, run by Novartis Pharmaceuticals at 44 sites in 9 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 9 inclusion and 11 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Australia, Germany, Spain, Poland and 4 more countries. 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?
Number of participants with adverse events, as a measure of safety and tolerability (time frame: From date of transition into this Rollover study until 28 days following the last dose. Subjects may continue to receive study medication until disease progression, death or unacceptable adverse event; there is no time limit for this outcome measure.). 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 22 Mar 2019.