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CancerPhase 1NCT01371487

GSK1120212 Food-effect Study

A Phase 1 study testing GSK1120212 in people with Cancer, run by GlaxoSmithKline at 3 sites 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

The purpose of the this study is to evaluate the effect of a high-fat, high calorie meal on the single dose PK of GSK1120212 in subjects with solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
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
40 participants
Where
3 sitesUnited States
Study dates
2 May 2011to 30 Sep 2011
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

  • A subject will be eligible for inclusion in this study only if all of the following criteria apply:
  • Male or female; 18 years of age or older at the time of consent
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Able to swallow and retain oral medication.
  • Histologically or cytologically confirmed diagnosis of a solid tumor.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 3).
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  • Adequate baseline organ function defined in Table 5 Definitions for Adequate Baseline Organ Function Absolute neutrophil count greater than or equal to 1.2 × 109/L Hemoglobin greater than or equal to9 g/dL Platelets greater than or equal to 75 × 109/L Prothrombin time (PT), International normalization ratio (INR)a and Partial thromboplastin time (PTT) less than or equal to 1.5 times ULN Hepatic Total bilirubin less than or equal to 1.5 times ULN ALT less than or equal to 2.5 times ULN Renal Creatinine or less than or equal to 1.5 times ULN Calculated creatinine clearance or greater than or equal to 50 mL/min 24-hour urine creatinine clearance greater than or equal to 50 mL/min Cardiac LVEF greater than or equal to LLNc by ECHO or MUGA
  • INR greater than 1.5 times ULN will be acceptable in case of subjects receiving therapeutic anticoagulants such as warfarin as long as INR is monitored during the study according to clinical practice.
  • Calculated by the Cockcroft-Gault formula (see Appendix 2).
  • If LLN is not defined for a given institution, then ejection fraction must be greater than or equal to 50%.
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception, as defined in Section 7.1.1, during the study and for 6 weeks following the last dose of study treatment.
  • Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in Section 7.1.2 from the time of the first dose of study treatment until 16 weeks following the last dose of study treatment (based on the lifecycle of sperm).

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • Currently receiving cancer therapy (e.g., chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or major surgery) within 3 weeks prior to randomization; chemotherapy regimens without delayed toxicity within 2 weeks prior to randomization; or use of an investigational anti-cancer drug within 4 weeks prior to randomization.
  • Has unresolved Grade 2 or greater toxicity (based on NCI-CTCAE, version 4.0) [NCI Common Terminology Criteria for Adverse Events, 2009] from previous anti-cancer therapy except Grade 2 decreased hemoglobin levels or alopecia.
  • Has pre-existing peripheral neuropathy of greater than or equal to Grade 2.
  • Has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer, prior to the first dose of study treatment in this study.
  • Has participated in a study that resulted in or made a donation of blood or blood products in excess of 500 mL within 56 days of the first dose of study treatment.
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  • Has presence of active GI disease or other condition (e.g., gastrectomy, bariatric surgery, small or large bowel resection, or cholecystectomy should be excluded) that may interfere significantly with the absorption of drugs. If clarification is needed as to whether a condition will significantly affect absorption of drugs, contact the GSK Medical Monitor.
  • Has any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions 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.
  • Has a history of interstitial lung disease or pneumonitis.
  • Is currently using a prohibited medication(s) or requires the use of any of the prohibited medications during the study (see Section 8.2).
  • NOTE: Use of anticoagulants such as warfarin is permitted; however, INR must be monitored in accordance with local institutional practice.
  • Has a history or current evidence/risk of RVO or CSR:
  • History of RVO or CSR, or predisposing factors to RVO or CSR (i.e., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension or diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)
  • Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:
  • Evidence of new optic disc cupping
  • Intraocular pressure greater than 21 mmHg as measured by tonography
  • Has symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
  • Note: Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for greater than 3 months, are asymptomatic and are not currently taking corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to Day 1 of the study are permitted.
  • Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs (EIAEDs).
  • Has a QtcB or QTcF (preferred) greater than or equal to 480 msec.
  • Has a history or evidence of cardiovascular risk including any of the following:
  • History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for greater 30 days prior to randomization are eligible.
  • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization.
  • History or evidence of current greater than or equal to Class II congestive heart failure as defined by New York Heart Association (NYHA) (Appendix 4).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • GSK Investigational Site

    Detroit, Michigan, 48201

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: An Open-Label, Two-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Single Dose Pharmacokinetics of the MEK Inhibitor, GSK1120212, in Subjects With Solid Tumors

The purpose of the this study is to evaluate the effect of a high-fat, high calorie meal on the single dose PK of GSK1120212 in subjects with solid tumors.

Read the detailed description

open-label, randomized, 2-treatment, 2-period, crossover study with incomplete wash-out to evaluate the effect of a high-fat, high calorie meal on the single dose PK of GSK1120212 in subjects with solid tumors. Subjects will be assigned to a fast/fed sequence according to the randomization code provided to the sites by GSK with subjects randomized to one of 2 possible treatment sequences (Table 1) with each sequence consisting of 2 treatments: a single 2.0 mg dose of GSK1120212 administered under fasted conditions and a single 2.0 mg dose of GSK1120212 administered with a high-fat, high-calorie meal

Conditions
Cancer
Being tested
GSK1120212
Medical subject headings
Neoplasms

What participants receive

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

  • GSK1120212Drug

    Oral/once-daily single doses on Day 1 of Periods 1 and 2

Study groups in NCT01371487
Study groupRoleWhat they receive
Treatment AExperimentalGSK1120212 Dose /Treatment 2.0 mg/Fasted
Receives: Drug: GSK1120212
Treatment BExperimentalGSK1120212 Dose /Treatment 2.0 mg/high fat, high calorie meal
Receives: Drug: GSK1120212

What is being measured

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

  1. evaluate the effect of a high-fat, high-calorie meal on the PK of a single dose of GSK1120212 administered to subjects

    • Area under the plasma concentration-time curve from time zero (pre-dose) to time t (AUC(0-t)), AUC(0-inf), Cmax, and tmax.

    Measured: Predose - 168 hours post dose period 1 and 2

Secondary outcomes (1)

  1. assess the short-term safety and tolerability of single oral doses of 2.0 mg of GSK1120212 administered to subjects

    vital signs, electrocardiograms (ECGs), clinical laboratory tests, and AEs

    Measured: Day 1/periods 1 and 2, Day 8 period 2 and follow-up.

Timeline

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

  1. First posted10 Jun 2011 (estimated)
  2. Study start2 May 2011
  3. Primary completion30 Sep 2011
  4. Study completion30 Sep 2011

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01371487
Sponsor's protocol ID
113709
Status last verified
Nov 2017
First submitted
9 Jun 2011
Last updated
13 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Cox DS, Papadopoulos K, Fang L, Bauman J, LoRusso P, Tolcher A, Patnaik A, Pendry C, Orford K, Ouellet D. Evaluation of the effects of food on the single-dose pharmacokinetics of trametinib, a first-in-class MEK inhibitor, in patients with cancer. J Clin Pharmacol. 2013 Sep;53(9):946-54. doi: 10.1002/jcph.115. Epub 2013 Jul 25.

    PubMed 23893461

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK1120212 in people with Cancer, run by GlaxoSmithKline at 3 sites 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 12 inclusion and 24 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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

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?

evaluate the effect of a high-fat, high-calorie meal on the PK of a single dose of GSK1120212 administered to subjects (time frame: Predose - 168 hours post dose period 1 and 2). 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 NCT01371487, which also lists 1 linked publication.

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 13 Nov 2017.

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