Last updated: 11/03/2018 12:35:39
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Combination Study of GSK1120212 with Gemcitabine in Subjects with Solid Tumors
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A Phase IB Combination Study of MEK inhibitor GSK1120212 with Gemcitabine in Subjects with Solid Tumors
Trial description: MEK112111 is a dose-escalation, Phase IB, open-label, single-arm, multi-center study. The primary objective of the study is to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 dosed in combination with gemcitabine in subjects with solid tumors.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Adverse events (AEs) and changes in laboratory values and vital signs.
Timeframe: From date of randomization until withdrawal from the study due to disease progression, AE, withdrawal of consent or study closure approximately 6 months after last subject was randomized.
Secondary outcomes:
Tumor response as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v 1.1
Timeframe: At screening and every 8 weeks until withdrawal from the study due to disease progression, AE, withdrawal of consent or study closure approximately 6 months after last subject was randomized.
drug levels in blood
Timeframe: first 15 days on study
Interventions:
Enrollment:
31
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
J.R. Infante, K.P. Papadopoulos, J.C. Bendell, A. Patnaik, H.A. Burris III, D. Rasco, S.F. Jones, L. Smith, D.S. Cox, M. Durante, K. Bellew, J. Park, N.T. Le, A.W. Tolcher. A Phase IB Study of Trametinib, an Oral MEK Inhibitor, in Combination with Gemcitabine in Advanced Solid Tumors. Eur J Cancer. 2013;49:2077-2085.
Medical condition
Leukaemia, Myelocytic, Acute
Product
trametinib
Collaborators
Not applicable
Study date(s)
August 2009 to July 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Age 18 years old or older and able to swallow oral medication.
- Chemotherapy, radiotherapy, or immunotherapy within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of GSK1120212.
- Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is shorter preceding the first dose of GSK1120212 – as long as a minimum of 14 days has passed between the last dose of the prior investigational anti-cancer drug and the first dose of GSK1120212.
Inclusion and exclusion criteria
Inclusion criteria:
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Age 18 years old or older and able to swallow oral medication.
- Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology (ECOG) scale.
- Histologically or cytologically confirmed diagnosis of a solid tumor malignancy that is either relapsed or refractory, or potentially responsive to gemcitabine.
- Tumor Type criteria as listed in protocol.
- Male subjects must agree to use one of the contraception methods listed in protocol.
- A female subject is eligible to participate if she is of non-childbearing potential as defined in the protocol or postmenopausal as defined in the protocol. If of child-bearing potential, she agrees to use protocol specified contraceptive methods
- Adequate organ system function as defined below in the protocol.
Exclusion criteria:
- Chemotherapy, radiotherapy, or immunotherapy within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of GSK1120212.
- Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is shorter preceding the first dose of GSK1120212 – as long as a minimum of 14 days has passed between the last dose of the prior investigational anti-cancer drug and the first dose of GSK1120212.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug, dimethy sulfoxide (DMSO), or excipients (See protocol)
- Use of a prohibited medication (as defined in protocol) or current use of anticoagulants (e.g. warfarin, heparin, low molecular weight heparin) at therapeutic levels. Low dose (prophylactic) anticoagulants are permitted provided that subject’s prothrombin time (PT) and partial thromboplastin time (PTT) meet entry criteria.
- Gastrointestinal disease predicted to interfere with absorption of an oral drug.
- History of retinal vein occlusion (RVO) or central serous retinopathy.
- Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for retinal vein thrombosis.
- Glaucoma diagnosed within one month prior to study day 1.
- Intraocular pressure > 21mm Hg as measured by tonography.
- Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. Subjects previously treated for these conditions that are asymptomatic and off corticosteroids for at least two months are permitted. Subjects are not permitted to receive enzyme inducing anti-epileptic drugs (EIAEDs).
- Unresolved toxicity greater than common terminology criteria for adverse events (CTCAE v4.0) grade 1 from previous anti-cancer therapy.
- History of acute coronary within the past 24 weeks.
- QTc interval greater than or equal to 480 mili seconds (msecs).
- Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Pregnant or lactating female.
- History of hepatitis B or C. NOTE: Subjects with evidence of cleared hepatitis B infection are permitted [Hepatitis B Surface Antigen (HBsAg) negative, anti-HBsAg positive and anti Hepatitis B core antigen (HBc) positive.]
Trial location(s)
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2011-18-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study 112111 can be found on the GSK Clinical Study Register.
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