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Breast CancerEarly Phase 1NCT01467310

Defining the Triple Negative Breast Cancer Kinome Response to GSK1120212

A Early Phase 1 study testing GSK1120212 in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

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

Research into treatments for breast cancer relies more and more on an understanding of how the cells of tumor tissue act when they are exposed to a new or different drug. To find these new or different drugs to treat cancer, researchers are looking at proteins that help cancer cells grow, such as a group of proteins… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
GSK1120212
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Jan 2012to 21 Mar 2016
Phase
Early 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed TNBC (i.e., ER negative, PR negative (each <10% staining by immunohistochemistry) and Her2 negative (0-1+ or FISH non-amplified; by clinical assay on primary tumor)
  • Stage I-IIIc disease:
  • Scheduled for lumpectomy or mastectomy
  • No prior or current therapy for breast cancer
  • Not considered candidate for therapeutic neoadjuvant treatment
  • For stage IV disease:
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  • Scheduled for surgical resection of oligometastatic disease
  • Previously untreated for breast cancer
  • Subject enrolls into LCCC9819
  • ECOG Performance Status 0-2
  • Normal end organ function as defined by the following:
  • Absolute neutrophil count (ANC)≥ 1.2 X 109/L;
  • Hemoglobin ≥ 9 g/dL;
  • Platelets ≥ 75 X 109/L;
  • PT/INR and PTT ≤ 1.2 X upper limit of normal (ULN);
  • Albumin ≥ 2.5 g/dL
  • Total bilirubin ≤ 1.5 x ULN mg/dL
  • AST and ALT ≤ 2.5 X ULN
  • Creatinine ≤ 1.5 X ULN OR Calculated creatinine clearance ≥50 mL/min OR 24-hour urine creatinine clearance ≥50 mL/min;
  • Ejection fraction ≥ LLN by ECHO (preferred) or MUGA
  • Age ≥18 years
  • Willing to use adequate contraception if applicable, and to continue use for 4 weeks post last dose of GSK1120212
  • Sufficient fresh or frozen tissue remaining from pre-treatment core incisional biopsy or willing to undergo biopsy for research purposes only (approximately 10mg or one core's worth of tissue needed)
  • Surgeon and Medical Oncologist agree one week window trial appropriate/safe for trial candidate and that surgery appointment can accommodate a 7 day (one week) treatment schedule
  • Able to swallow oral medications

Who cannot join

  • Pregnant or lactating female
  • Currently active GI disease, or prior surgery that may affect ability to absorb oral medications
  • Prior radiation therapy to the target lesion
  • History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR):
  • History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)
  • Current use of a prohibited medication or requires any of these medications during treatment with GSK1120212 (see section 4.6).
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  • Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is shorter, prior to the first dose of GSK1120212. A minimum of 10 days between termination of the investigational drug and administration of GSK1120212 is required. In addition, any drug-related toxicity should have recovered to Grade 1 or less.
  • Prior treatment with MEK or BRAF inhibitors
  • Any major radiotherapy, or immunotherapy within the last four weeks; use of erythropoietin replacement or bisphosphonates is considered supportive care and their use is permitted
  • Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease)
  • History or evidence of cardiovascular risk including any of the following:
  • QTc interval >/= 480 msecs.
  • Clinically significant uncontrolled arrhythmias Exception: subjects with controlled atrial fibrillation for >30 days prior to day 1 of treatment with GSK1120212 are eligible
  • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 24 weeks
  • ≥Class II heart failure as defined by the New York Heart Association (NYHA) functional classification system (see Appendix C)
  • Known human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection which will be allowed)
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug, dimethyl sulfoxide (DMSO), or excipients
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
  • Any other concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Research into treatments for breast cancer relies more and more on an understanding of how the cells of tumor tissue act when they are exposed to a new or different drug. To find these new or different drugs to treat cancer, researchers are looking at proteins that help cancer cells grow, such as a group of proteins called Kinases. In this study the investigators want to look at the activity of kinases when a particular experimental drug called GSK1120212 is administered. GSK1120212 blocks a kinase called MEK. GSK1120212 is not yet approved by the FDA for use in breast cancer patients. The investigators want to give subjects GSK1120212 for a short period of time (one week) to see how MEK and the other kinases function in cancer cells both before and after the study drug is given. This study is not intended to treat cancer, it is looking at ways that the investigators may treat cancer in the future.

Read the detailed description

In this study the investigators want to look at the activity of kinases when a particular experimental drug called GSK1120212 is administered. GSK1120212 blocks a kinase called MEK. GSK1120212 is not yet approved by the FDA for use in breast cancer patients. The investigators want to give subjects GSK1120212 for a short period of time (one week) to see how MEK and the other kinases function in cancer cells both before and after the study drug is given. The investigators are giving this drug for research purposes only. The length of time it is being given is not intended to treat cancer.

Research into treatments for breast cancer relies more and more on an understanding of how the cells of tumor tissue act when they are exposed to a new or different drug. To find these new or different drugs to treat cancer, researchers are looking at proteins that help cancer cells grow, such as a group of proteins called Kinases. This is important because many of the newest cancer drugs are designed to block kinases causing the cancer cells to die and the tumors to shrink. However, blocking only one of the kinases at a time is often less effective than the investigators expected because when you block one kinase another can take its place. For this reason, the investigators may need to treat breast cancer with more than one kinase-blocking drug at a time. However, the investigators don't yet know what the best combination of drugs should be, because it is hard to measure all the possible kinases. Previous studies have only been able to identify less than 10% of the hundreds of kinases in cancer cells.

Recently researchers here at UNC have developed a process that can identify may (more than half) of these kinases. This can tell us which kinases need to be blocked at the same time to make tumors shrink so that the investigators can design the best combinations of kinase blocking drugs for triple negative breast cancer. This is especially important for individuals with triple negative breast cancer (TNBC) because there are fewer drugs available that can block molecules that affect tumor growth. The investigators believe that kinase-blocking drugs have the potential to be a more effective treatment for people with TNBC.

Conditions
Breast Cancer
Being tested
GSK1120212
Keywords
GSK1120212, TNBC, Triple Negative Breast Cancer, Surgical Resection
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

  • GSK1120212Drug

    1.5 to 2.0 mg taken orally every day for seven days.

Study groups in NCT01467310
Study groupRoleWhat they receive
GSK1120212ExperimentalNot described
Receives: Drug: GSK1120212

What is being measured

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

  1. the number and type of kinases in participant tissue sample prior to administration of drug compared to post-treatment.

    use of pan kinase inhibitors immobilized on beads to capture expressed kinases in cells and tumors. The activation state of more than 60% of the expressed kinome, defined by RNA-seq, will be analyzed using mass spectrometry analysis of the captured kinases.

    Measured: Two years

Secondary outcomes (2)

  1. the number and type of kinases that produce a compensatory response to MEK inhibitor

    The activation state of more than 60% of the expressed kinome, defined by RNA-seq, will be analyzed using mass spectrometry analysis of the captured kinases. For each activated kinase, a drug therapy that combines an inhibitor of that kinase with a MEK inhibitor will be identified.

    Measured: Two years

  2. the number of participants with adverse events

    Identify any safety issues in subjects treated with drug GSK1120212

    Measured: Two years

Timeline

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

  1. First posted8 Nov 2011 (estimated)
  2. Study startJan 2012
  3. Primary completion21 Mar 2016
  4. Study completion21 Mar 2016

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
Early Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01467310
Sponsor's protocol ID
LCCC 1122
Other IDs
11-1689, CA058223
Status last verified
Aug 2020
First submitted
13 Oct 2011
Last updated
2 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing GSK1120212 in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

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 25 inclusion and 19 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 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

the number and type of kinases in participant tissue sample prior to administration of drug compared to post-treatment. (time frame: Two years). 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 NCT01467310.

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 2 Sep 2020.

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