CancerPhase 1NCT01138033
Study of a Focal Adhesion Kinase Inhibitor in Subjects With Solid Tumors
A Phase 1 study testing GSK2256098 in people with Cancer, run by GlaxoSmithKline at 10 sites in 3 countries.
Trial summary
This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Following identification of the MTD, enrollment into Parts 2, 3, 4 and 5 may be concurrent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- GSK2256098
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 27 Jul 2010to 21 Dec 2015
- 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
- Written informed consent provided.
- 18 years old or older.
- Confirmed diagnosis of a solid tumor malignancy that is not responsive to accepted standard therapies or for which there is no standard or curative therapy. Subjects with malignancies related to HIV infection or organ transplantation are excluded.
- Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group scale
- Able to swallow and retain oral medication
- A male is eligible to enter and participate in the study if he either:
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- agrees to abstain from sexual intercourse from the first dose of study drug and until 21 days after last dose of study medication, or
- agrees to use a condom and occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/suppository from the first dose of study drug and until 21 days after last dose of study medication,
- or is surgically sterile. NOTE: Male subjects must use contraception to prevent pregnancy in a female partner and prevent exposure of any partner to semen by any means (refer to Section 8.1).
- A female is eligible to enroll in the study if she is of:
- Non-child bearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who is characterized by at least one of the following:
- oHas had a hysterectomy oHas had a bilateral oophorectomy (ovariectomy) oHas had a bilateral tubal ligation oIs post-menopausal (total cessation of menses for ≥ 1 year)
- Childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following from at least 2 weeks prior to the first dose of study drug and until 21 days after last dose of study medication:
- Use an intrauterine device (IUD) with a documented failure rate of less than 1% per year.
- Have intercourse only with a vasectomized partner who is sterile and is the sole sexual partner for that woman.
- Complete abstinence from sexual intercourse.
- Use double barrier contraception defined as condom with occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/suppository from the first dose of study drug and until 21 days after last dose of study medication.
- NOTE: Oral contraceptives are not reliable due to potential for drug-drug interaction.
- Adequate organ system function
- Paraffin-embedded, archival tumor tissue available for testing. If archival tissue is available but it is not feasible to obtain within the screening period, subjects may enroll and enter the study prior to these specimens being received for analyses. In situations that archival tumor specimens are not available, (i.e. insufficient archival tumor specimens or a local hospital refuses to release a tissue block or specimen for the purposes of the study), only subjects for Part 1 would be eligible under such circumstances if there is documentation to explain why this tissue is not available
- Confirmed cancers of the breast, esophagus, ovary, head and neck, colon, rectum, stomach, liver, endometrium, cervix, oral epithelium, thyroid, lung, prostate, sarcoma and other tumors reported in medical literature to overexpress FAK that are not responsive to accepted standard therapies or for which there is no standard or curative therapy.
- Subjects enrolled in Part 3 must have solid tumors that are amenable to biopsy.
- Subjects with glioblastoma multiforme at first or second recurrence defined as one or two progressions as Grade 4 astrocytic tumor since original diagnosis of any grade glioma.
- Subjects with prior treatment with bevacizumab (approximately 10 evaluable subjects) and subjects without prior treatment with anti-angiogenic therapy (includes bevacizumab and VEGFR inhibitors) will be allowed to enroll (approximately 10 evaluable subjects). For subjects with prior bevacizumab treatment, they should have progressed while receiving bevacizumab as defined by the RANO criteria. [WEN PY, 2010]
- Recurrent or refractory disease must meet all of the following criteria:
- Received prior chemoradiotherapy that incorporated temozolomide
- Confirmed true progressive disease (rather than pseudoprogression) according to the proposed RANO criteria [Wen PY, 2010]
- Progressive disease occurring within the first 12 weeks after completion of chemoradiotherapy must be radiographically documented (i.e., new area of enhancement) as being clearly outside the radiation field or must be pathologically confirmed
- Progressive disease occurring at ≥ 12 weeks after completion of chemoradiotherapy should include at least one of the following: -New contrast-enhancing lesion on decreasing, stable, or increasing doses of corticosteroids (new contrast- enhancing nonmeasurable disease is permitted) OR
- Increase of 25% in the sum of the products of perpendicular diameters of the contrast-enhancing lesions compared to baseline (e.g., 1st postradiotherapy scan) or best response after initiation of therapy while on stable or increasing doses of corticosteroids OR
- Significant increase in T2/FLAIR nonenhancing lesion (for subjects receiving antiangiogenic therapy) compared to baseline (e.g., 1st postradiotherapy scan) or best response after initiation of therapy on stable, or increasing doses of corticosteroids OR
- Clear radiographic progression of nonmeasurable lesions NOTE: An increase in corticosteroid dose or clinical deterioration not attributable to concurrent medication or comorbid conditions alone is not sufficient to indicate progressive disease for the purpose of entry onto the study.
- Documented radiographic presence of at least one measurable or non-measurable lesion as defined by the RANO criteria [Wen PY, 2010]
- If recent resection or biopsy of tumor has taken place, then all of the following must apply:
- Planned first dose of GSK2256098 must be > 28 days after surgery (or > 7 days after core needle biopsy)
- Subject has recovered from the effects of surgery
- Subject has at least one non-measurable residual lesion following surgery as defined by the RANO criteria [WEN PY, 2010]
Who cannot join
- Use of an investigational anti-cancer drug within 28 days or 5 half-lives with a minimum duration of 10 days from prior therapy preceding the first dose of GSK2256098 OR Chemotherapy within the last 3 weeks (6 weeks for prior nitrosourea or mitomycin C) OR any major surgery, radiotherapy, or immunotherapy within the last 4 weeks.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug. (To date there are no known approved drugs chemically related to GSK2256098.)
- Current use of a prohibited medication or requires any of these medications during treatment with GSK2256098 (Section 9.2).
- Current use of warfarin for therapeutic anticoagulation. NOTE: Low molecular weight heparin is permitted. PT/PTT must meet the inclusion criteria. .
- Presence of an active gastrointestinal disease or other condition known to interfere significantly with the absorption, distribution, metabolism, or excretion of drugs OR prior resection of small intestine.
- Unresolved toxicity greater than Grade 1 from previous anti-cancer therapy except alopecia.
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- QTc interval > 450 msecs in males, 470 msec in women or congenital long QT syndrome. QTc calculation to be calculated by Fridericia formula. (Section 7.2.3)
- History of acute coronary syndromes (including unstable angina and myocardial infarction), atrial fibrillation, coronary angioplasty, or stenting within the past 24 weeks.
- Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Symptomatic or untreated leptomeningeal or brain metastases. Subjects previously treated for these conditions who are asymptomatic and have not received corticosteroid and P450-inducing anti-epileptic medication for at least 2 months are permitted.
- Primary malignancy of the central nervous system.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Concurrent condition that in the Investigator's opinion would jeopardize compliance with the protocol.
- Nursing female.
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice or kumquats, pummelos, exotic citrus fruit (i.e., star fruit, bitter melon), grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
- Any serious and/or unstable pre-existing medical, psychiatric or other condition (including lab abnormalities) that could interfere with subject safety or obtaining informed consent.
- Additional Exclusion Criteria - Part 4 only:
- Subjects with >/=Grade 1 intracranial hemorrhage
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United Kingdom6 sites
GSK Investigational Site
Glasgow, G61 1BD
GSK Investigational Site
London, NW1 2BU
GSK Investigational Site
London, W12 0HS
GSK Investigational Site
London, W1G 6AD
GSK Investigational Site
Manchester, M20 4BX
GSK Investigational Site
Newcastle upon Tyne, NE7 7DN
Australia2 sites
GSK Investigational Site
Heidelberg, Victoria, 3084
GSK Investigational Site
Nedlands, Western Australia, 6009
France2 sites
GSK Investigational Site
Caen, 14033
GSK Investigational Site
Villejuif, 94805
About this study
Official title: A Phase I Open-Label Dose Escalation Study of the Focal Adhesion Kinase Inhibitor, GSK2256098, in Subjects With Solid Tumors
This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Following identification of the MTD, enrollment into Parts 2, 3, 4 and 5 may be concurrent. Part 2 will explore further the safety, PK, tolerability, and anti-tumor activity of GSK2256098 in subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will characterize the range of biologically effective doses by assessing pharmacodynamic (PD) markers in hair, skin and tumor tissue at doses that will not go lower than 80 mg or above the MTD dose levels tested during the Phase 1 dose escalation. Part 4 will explore further the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed glioblastoma multiforme (GBM). The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to explore the anti-tumor activity of GSK2256098, and to explore relationships between GSK2256098 PK, PD and clinical endpoints. Part 5 will investigate the time course, the extent of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098 at Day 15 and later time points. The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098.
Read the detailed description
This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Following identification of the MTD, enrollment into Parts 2, 3, 4, and 5 may be concurrent. Part 2 will explore further the safety, PK, tolerability, and anti-tumor activity of GSK2256098 in subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will characterize the range of biologically effective doses by assessing pharmacodynamic (PD) markers in hair, skin and tumor tissue at doses that will not go lower than 80 mg or above the MTD dose levels tested during the Phase 1 dose escalation. Part 4 will explore further the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed glioblastoma multiforme (GBM). The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to explore the anti-tumor activity of GSK2256098, and to explore relationships between GSK2256098 PK, PD and clinical endpoints.
Subjects with solid tumors will receive GSK2256098 orally without interruption on consecutive days. The planned starting dose in Part 1 will be a total daily dose of 160 mg administered as 80 mg twice daily (BID) during the repeat dose phase of the study. In the first cohort, administration of study drug will be initiated as a single dose (80 mg) on Day 1 that will be followed by collection of PK samples. Subjects may then begin repeat dosing (80 mg BID) on Day 2 following the collection of the 24-h PK sample. In subsequent cohorts, administration of study drug will be given as a single dose (half the total daily dose) on Day 1 followed by collection of PK samples. Subjects may begin repeat dosing on Day 2 following collection of the 24-h PK sample.
During dose escalation (Part 1), a modified accelerated dose titration design will be followed by a standard 3+3 dose escalation design until the MTD is established. After the MTD is established approximately 30 additional subjects with tumors reported to have FAK over-expression will be enrolled to further explore the safety, tolerability and clinical activity of GSK2256098 (Part 2). Additional cohorts below the MTD may be expanded to further explore and characterize the range of biologically effective doses (Part 3). Part 4 will further explore the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed glioblastoma multiforme (GBM). Part 5 will investigate the time course, the extent of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098 at Day 15 and later time points. The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098.
- Conditions
- Cancer
- Being tested
- GSK2256098
- Keywords
- pharmacodynamics, cancer, focal adhesion kinase inhibitor, pharmacokinetics, solid tumors, Phase 1
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2256098Drug
GSK2256098 is a potent focal adhesion kinase inhibitor that will be administered orally as 20, 100 or 250 mg capsules. The starting dose in Part 1 is 80 mg twice daily. The dose will continue to be increased until the maximum tolerated dose is identified.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Part 1 - dose escalation; starting dose 80 mg BID Receives: Drug: GSK2256098 |
| Part 2 | Experimental | Part 2 - Dose expansion phase of the study at the maximum tolerated dose and schedule identified in Part 1 in patients with tumors known to over express FAK Receives: Drug: GSK2256098 |
| Part 3 | Experimental | Part 3 - Characterize the biologically active dose range by analysis of PD markers in skin, hair and in tumor tissue in subjects with solid tumors amendable to biopsy and know to over express FAK Receives: Drug: GSK2256098 |
| Part 4 | Experimental | Part 4 - Explore further the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed glioblastoma multiforme (GBM). Receives: Drug: GSK2256098 |
| Part 5 | Experimental | Part 5 will investigate the time course, the extent of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098 at Day 15 and later time points. Receives: Drug: GSK2256098 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Maximum tolerated dose, identify the recommended Phase 2 dose(s), dose limiting toxicities, safety and tolerability of GSK2256098 given orally on consecutive days.
Measured: Until disease progression
Secondary outcomes (4)
To characterize the pharmacokinetics of GSK2256098 in blood after single- and repeat-dose administration
Measured: Until disease progression
To identify a range of biologically active doses
Measured: Until disease progression
To explore anti-tumor activity after treatment with GSK2256098
Measured: Until disease progression
To explore relationships between GSK2256098 PK, PD and clinical endpoints
Measured: Until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study start27 Jul 2010
- Primary completion21 Dec 2015
- Study completion21 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138033
- Sponsor's protocol ID
- 113517
- Status last verified
- May 2017
- First submitted
- 3 Jun 2010
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Brown NF, Williams M, Arkenau HT, Fleming RA, Tolson J, Yan L, Zhang J, Singh R, Auger KR, Lenox L, Cox D, Lewis Y, Plisson C, Searle G, Saleem A, Blagden S, Mulholland P. A study of the focal adhesion kinase inhibitor GSK2256098 in patients with recurrent glioblastoma with evaluation of tumor penetration of [11C]GSK2256098. Neuro Oncol. 2018 Nov 12;20(12):1634-1642. doi: 10.1093/neuonc/noy078.
PubMed 29788497
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label Dose Escalation Study of the Focal Adhesion Kinase Inhibitor, GSK2256098, in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01138033
- Acronym / sponsor ID
- 113517
- Conditions
- Cancer
- Keywords
- pharmacodynamics, cancer, focal adhesion kinase inhibitor, pharmacokinetics, solid tumors, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2010 (actual)
- Primary completion
- 21 Dec 2015 (actual)
- Study completion
- 21 Dec 2015 (actual)
- First posted
- 7 Jun 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 study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Following identification of the MTD, enrollment into Parts 2, 3, 4 and 5 may be concurrent. Part 2 will explore further the safety, PK, tolerability, and anti-tumor activity of GSK2256098 in subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will characterize the range of biologically effective doses by assessing pharmacodynamic (PD) markers in hair, skin and tumor tissue at doses that will not go lower than 80 mg or above the MTD dose levels tested during the Phase 1 dose escalation. Part 4 will explore further the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed glioblastoma multiforme (GBM). The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to explore the anti-tumor activity of GSK2256098, and to explore relationships between GSK2256098 PK, PD and clinical endpoints. Part 5 will investigate the time course, the extent of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098 at Day 15 and later time points. The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098.
Detailed description
This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Following identification of the MTD, enrollment into Parts 2, 3, 4, and 5 may be concurrent. Part 2 will explore further the safety, PK, tolerability, and anti-tumor activity of GSK2256098 in subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will characterize the range of biologically effective doses by assessing pharmacodynamic (PD) markers in hair, skin and tumor tissue at doses that will not go lower than 80 mg or above the MTD dose levels tested during the Phase 1 dose escalation. Part 4 will explore further the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed glioblastoma multiforme (GBM). The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to explore the anti-tumor activity of GSK2256098, and to explore relationships between GSK2256098 PK, PD and clinical endpoints.
Subjects with solid tumors will receive GSK2256098 orally without interruption on consecutive days. The planned starting dose in Part 1 will be a total daily dose of 160 mg administered as 80 mg twice daily (BID) during the repeat dose phase of the study. In the first cohort, administration of study drug will be initiated as a single dose (80 mg) on Day 1 that will be followed by collection of PK samples. Subjects may then begin repeat dosing (80 mg BID) on Day 2 following the collection of the 24-h PK sample. In subsequent cohorts, administration of study drug will be given as a single dose (half the total daily dose) on Day 1 followed by collection of PK samples. Subjects may begin repeat dosing on Day 2 following collection of the 24-h PK sample.
During dose escalation (Part 1), a modified accelerated dose titration design will be followed by a standard 3+3 dose escalation design until the MTD is established. After the MTD is established approximately 30 additional subjects with tumors reported to have FAK over-expression will be enrolled to further explore the safety, tolerability and clinical activity of GSK2256098 (Part 2). Additional cohorts below the MTD may be expanded to further explore and characterize the range of biologically effective doses (Part 3). Part 4 will further explore the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed glioblastoma multiforme (GBM). Part 5 will investigate the time course, the extent of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098 at Day 15 and later time points. The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: GSK2256098Part 1 - dose escalation; starting dose 80 mg BID |
| Part 2 | Experimental | Drug: GSK2256098Part 2 - Dose expansion phase of the study at the maximum tolerated dose and schedule identified in Part 1 in patients with tumors known to over express FAK |
| Part 3 | Experimental | Drug: GSK2256098Part 3 - Characterize the biologically active dose range by analysis of PD markers in skin, hair and in tumor tissue in subjects with solid tumors amendable to biopsy and know to over express FAK |
| Part 4 | Experimental | Drug: GSK2256098Part 4 - Explore further the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed glioblastoma multiforme (GBM). |
| Part 5 | Experimental | Drug: GSK2256098Part 5 will investigate the time course, the extent of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098 at Day 15 and later time points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Written informed consent provided.
- 18 years old or older.
- Confirmed diagnosis of a solid tumor malignancy that is not responsive to accepted standard therapies or for which there is no standard or curative therapy. Subjects with malignancies related to HIV infection or organ transplantation are excluded.
- Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group scale
- Able to swallow and retain oral medication
Key exclusion criteria (18 listed)
- Use of an investigational anti-cancer drug within 28 days or 5 half-lives with a minimum duration of 10 days from prior therapy preceding the first dose of GSK2256098 OR Chemotherapy within the last 3 weeks (6 weeks for prior nitrosourea or mitomycin C) OR any major surgery, radiotherapy, or immunotherapy within the last 4 weeks.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug. (To date there are no known approved drugs chemically related to GSK2256098.)
- Current use of a prohibited medication or requires any of these medications during treatment with GSK2256098 (Section 9.2).
- Current use of warfarin for therapeutic anticoagulation. NOTE: Low molecular weight heparin is permitted. PT/PTT must meet the inclusion criteria. .
- Presence of an active gastrointestinal disease or other condition known to interfere significantly with the absorption, distribution, metabolism, or excretion of drugs OR prior resection of small intestine.
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 |
|---|---|---|
| GSK2256098GSK2256098 is a potent focal adhesion kinase inhibitor that will be administered orally as 20, 100 or 250 mg capsules. The starting dose in Part 1 is 80 mg twice daily. The dose will continue to be increased until the maximum tolerated dose is identified. | Drug | Part 1, Part 2, Part 3, Part 4, Part 5 |
Primary outcome
To evaluate the Maximum tolerated dose, identify the recommended Phase 2 dose(s), dose limiting toxicities, safety and tolerability of GSK2256098 given orally on consecutive days.
Time frame: Until disease progression
4 secondary outcomes
To characterize the pharmacokinetics of GSK2256098 in blood after single- and repeat-dose administration
Time frame: Until disease progression
To identify a range of biologically active doses
Time frame: Until disease progression
To explore anti-tumor activity after treatment with GSK2256098
Time frame: Until disease progression
To explore relationships between GSK2256098 PK, PD and clinical endpoints
Time frame: Until disease progression
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 11 May 2017.
- Derived from this study: PubMed 29788497Brown NF, Williams M, Arkenau HT, Fleming RA, Tolson J, Yan L, Zhang J, Singh R, Auger KR, Lenox L, Cox D, Lewis Y, Plisson C, Searle G, Saleem A, Blagden S, Mulholland P. A study of the focal adhesion kinase inhibitor GSK2256098 in patients with recurrent glioblastoma with evaluation of tumor penetration of [11C]GSK2256098. Neuro Oncol. 2018 Nov 12;20(12):1634-1642. doi: 10.1093/neuonc/noy078.
- Results for study 113517 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK2256098 in people with Cancer, run by GlaxoSmithKline at 10 sites in 3 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 37 inclusion and 18 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Australia, France. 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?
To evaluate the Maximum tolerated dose, identify the recommended Phase 2 dose(s), dose limiting toxicities, safety and tolerability of GSK2256098 given orally on consecutive days. (time frame: Until disease progression). 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 NCT01138033, 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 11 May 2017.