Solid TumoursPhase 1NCT01266954
An Open Label Study To Investigate the Pharmacokinetics and Pharmacodynamics of Repeat Escalating Doses of the Oral AKT Inhibitor GSK2141795 by 18F FDG PET Analysis in Subjects With Ovarian Cancer
A Phase 1 study testing GSK2141795 in people with Solid Tumours, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The purpose of this study is to explore the potential dose response relationship between the pharmacokinetics of GSK2141795 and [18F] FDG PET pharmacodynamic markers of glucose metabolism in tumor tissue. Three to six subjects will be enrolled in each cohort and dosed with repeat escalating doses of GSK2141795. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Solid Tumours
- What is being tested?
- GSK2141795
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2010to 1 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving written informed consent
- Females of non-childbearing potential, 18 years or older with ovarian cancer
- Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent ovarian cancer
- Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent uterine or gastro-oesophageal tumors (these tumor types will only be included if there is poor enrollment of patients with ovarian cancer)
- Disease at least 2 cm suitable for assessment by imaging
- Performance Status score of 0, 1 or 2 according to the Eastern Cooperative Oncology Group scale
- Adequate organ systems function
Who cannot join
- Chemotherapy, radiotherapy, or immunotherapy within 28 days prior to the first dose of GSK2141795
- Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is shorter, prior to the first dose of GSK2141795
- Current use of a prohibited medication
- Anticoagulants at therapeutic doses are permitted only after consultation with the GSK Medical Monitor
- Presence of active gastrointestinal disease or other condition that could affect gastrointestinal absorption
- Any major surgery within the last four weeks of screening
Show all 18Show fewer
- Unresolved toxicity greater than or equal to Grade 2 from previous anti-cancer therapy
- Previously diagnosed diabetes mellitus
- Current use of oral corticosteroids, with the exception of inhaled or topical corticosteroids
- Any serious or unstable pre-existing medical, psychiatric, or other condition
- Symptomatic or untreated CNS metastases or leptomeningeal involvement
- Evidence of severe or uncontrolled systemic diseases
- QTc interval ≥ 470 msecs
- Other clinically significant ECG abnormalities
- History of myocardial infarction, acute coronary syndromes
- Class III or IV heart failure
- Pregnant or Lactating patients
- History of hepatitis B or C or HIV
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the potential dose response relationship between the pharmacokinetics of GSK2141795 and [18F] FDG PET pharmacodynamic markers of glucose metabolism in tumor tissue. Three to six subjects will be enrolled in each cohort and dosed with repeat escalating doses of GSK2141795. [18F] FDG PET imaging and optional tumor biopsies will be done prior to initiation of dosing and sequentially at select time points during the first five weeks of dosing. The maximal dose of a given schedule evaluated in this study will not exceed the maximal tolerated dose established in the first-time-in-human trial PCS112689 for the same schedule.
- Conditions
- Solid Tumours
- Being tested
- GSK2141795
- Keywords
- Cancer, 18F FDG, PK, PET, Positron Emission Tomography, PD, AKT Inhibitor, GSK2141795
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2141795Drug
GSK2141795 is an oral, low nanomolar pan-AKT kinase inhibitor that demonstrates activity in hematologic and solid tumor cell lines. It also delays tumor growth in a dose dependent manner in solid tumor xenograft mouse models
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 | Experimental | Three to six patients on a medium dose of GSK2141795 for four weeks Receives: Drug: GSK2141795 |
| Stage 2 | Experimental | Nine to eighteen subjects on a low, medium or high dose of GSK2141795 for four weeks Receives: Drug: GSK2141795 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of GSK2141795 in the blood (ng/ml) from baseline
Measured: 6 months
Secondary outcomes (2)
The net unidirectional uptake of FDG (Ki) from baseline
Measured: 6 months
The change in size of tumor from baseline (RECIST Criteria)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study start1 Jun 2010
- Primary completion1 Sep 2011
- Study completion1 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies 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
- 36 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
- NCT01266954
- Sponsor's protocol ID
- 113124
- Status last verified
- Nov 2017
- First submitted
- 21 Oct 2010
- Last updated
- 9 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study To Investigate the Pharmacokinetics and Pharmacodynamics of Repeat Escalating Doses of the Oral AKT Inhibitor GSK2141795 by 18F FDG PET Analysis in Subjects With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01266954
- Acronym / sponsor ID
- 113124
- Conditions
- Solid Tumours
- Keywords
- Cancer, 18F FDG, PK, PET, Positron Emission Tomography, PD, AKT Inhibitor, GSK2141795
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 1 Sep 2011 (actual)
- Study completion
- 1 Sep 2011 (actual)
- First posted
- 24 Dec 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.
The purpose of this study is to explore the potential dose response relationship between the pharmacokinetics of GSK2141795 and [18F] FDG PET pharmacodynamic markers of glucose metabolism in tumor tissue. Three to six subjects will be enrolled in each cohort and dosed with repeat escalating doses of GSK2141795. [18F] FDG PET imaging and optional tumor biopsies will be done prior to initiation of dosing and sequentially at select time points during the first five weeks of dosing. The maximal dose of a given schedule evaluated in this study will not exceed the maximal tolerated dose established in the first-time-in-human trial PCS112689 for the same schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | Experimental | Drug: GSK2141795Three to six patients on a medium dose of GSK2141795 for four weeks |
| Stage 2 | Experimental | Drug: GSK2141795Nine to eighteen subjects on a low, medium or high dose of GSK2141795 for four weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Capable of giving written informed consent
- Females of non-childbearing potential, 18 years or older with ovarian cancer
- Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent ovarian cancer
- Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent uterine or gastro-oesophageal tumors (these tumor types will only be included if there is poor enrollment of patients with ovarian cancer)
- Disease at least 2 cm suitable for assessment by imaging
Key exclusion criteria (18 listed)
- Chemotherapy, radiotherapy, or immunotherapy within 28 days prior to the first dose of GSK2141795
- Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is shorter, prior to the first dose of GSK2141795
- Current use of a prohibited medication
- Anticoagulants at therapeutic doses are permitted only after consultation with the GSK Medical Monitor
- Presence of active gastrointestinal disease or other condition that could affect gastrointestinal absorption
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 |
|---|---|---|
| GSK2141795GSK2141795 is an oral, low nanomolar pan-AKT kinase inhibitor that demonstrates activity in hematologic and solid tumor cell lines. It also delays tumor growth in a dose dependent manner in solid tumor xenograft mouse models | Drug | Stage 1, Stage 2 |
Primary outcome
The amount of GSK2141795 in the blood (ng/ml) from baseline
Time frame: 6 months
2 secondary outcomes
The net unidirectional uptake of FDG (Ki) from baseline
Time frame: 6 months
The change in size of tumor from baseline (RECIST Criteria)
Time frame: 6 months
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 9 Nov 2017.
- Results for study 113124 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Solid Tumours
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK2141795 in people with Solid Tumours, run by GlaxoSmithKline at 1 site in United Kingdom.
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 7 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 9 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 1 site in United Kingdom. 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?
The amount of GSK2141795 in the blood (ng/ml) from baseline (time frame: 6 months). 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 9 Nov 2017.