Continuation Study of the Oral AKT Inhibitor GSK2110183
20 juni 2019 bijgewerkt door: Novartis Pharmaceuticals
An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Hematologic Malignancies
This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was designed to provide continued access to eligible subjects who had previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on behalf of GSK.
Eligible subjects had previously received clinical benefit from continued treatment and had to have ad an acceptable safety profile with GSK2110183.
Subjects who had participated in a GSK2110183 combination study with an approved anti-cancer agent were also be eligible to enroll in this rollover study.
Subjects who participated in combination studies with two investigational compounds (one being GSK2110183) were not eligible for this rollover study.
Subjects were enrolled by cohort based on the duration and treatment received while in their parent study.
Safety assessments (physical examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse events) were evaluated during this study.
Disease assessment were performed using local standard of care imaging practices and criteria appropriate for disease type and location.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Werkelijk)
11
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Victoria
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Melbourne, Victoria, Australië, 3004
- Novartis Investigative Site
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Ontario
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Toronto, Ontario, Canada, M5G 1Z6
- Novartis Investigative Site
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Galway, Ierland
- Novartis Investigative Site
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Seoul, Korea, republiek van, 110-744
- Novartis Investigative Site
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21231
- Novartis Investigative Site
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Novartis Investigative Site
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New York
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New York, New York, Verenigde Staten, 10029
- Novartis Investigative Site
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New York, New York, Verenigde Staten, 10065
- Novartis Investigative Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Has provided signed informed consent for this study.
- Is currently participating in a GSK2110183 study (monotherapy or in combination with an approved anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK.
- Currently benefitting from continued treatment and have an acceptable safety profile with GSK2110183 as determined by the investigator following previous treatment with GSK2110183 either as monotherapy or as part of a combination treatment regimen.
- Continued ability to swallow and retain orally administered study treatment(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
- Male subjects with a female partner of childbearing potential must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 16 weeks after the last dose of GSK2110183.
- Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 4 weeks after the last dose of GSK2110183.
- Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study.
- Maintain a performance status score of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) scale
- Subjects with Type II diabetes are only allowed if their HbA1C is less than 8 percent at study entry.
- Have adequate organ system function
Exclusion Criteria:
- Permanent discontinuation of GSK2110183 in the parent study due to toxicity or disease progression.
- Concomitant use of any type of anti-cancer treatment other than studied in the parent protocol.
- Local access to commercially available GSK2110183.
- Current use of a prohibitive medication(s)
- Current use of anticoagulants
- Any unresolved toxicity greater than Grade 2 , except for alopecia, (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment at the time of transition to this study.
- History of HIV infection.
- Peripheral neuropathy greater than Grade 1
- History of hepatitis B or C infection (subjects with evidence of cleared hepatitis B are permitted).
- Evidence of severe or uncontrolled systemic diseases (e.g., unstable, or uncompensated respiratory, hepatic, renal, metabolic or cardiac disease).
- QTcF interval greater than 500 msecs at the time of transition to this study.
- Other clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
- Evidence of current Class II, III, or IV heart failure as defined by the New York Heart Association [NYHA, 1994] functional classification system at the time of transition to this study.
- Symptomatic or untreated leptomeningeal, CNS or brain metastases or spinal cord compression at the time of transition to this study.
- Lactating female or female who becomes pregnant prior to transition to this study.
- Previously diagnosed diabetes mellitus Type I. Subjects with Type II diabetes are allowed if entry criteria are fulfilled
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: GSK2110183 (afuresertib)
All patients received the GSK2110183 (afuresertib) treatment
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Afuresertib is an oral, low nanomolar pan-AKT kinase inhibitor immediate release (IR) 50 mg or 75 mg tablets was to be taken orally with at least 200 mL of water, with or without food, in the morning.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants With at Least One Adverse Events (AEs)
Tijdsspanne: from the time of consent until the final study visit up to approx. 76 months
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Adverse Events (AEs) includes Summary of adverse events, drug related AEs, Serious adverse events, adverse events leading to study treatment discontinuation and death.
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from the time of consent until the final study visit up to approx. 76 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
8 februari 2012
Primaire voltooiing (Werkelijk)
20 juni 2018
Studie voltooiing (Werkelijk)
20 juni 2018
Studieregistratiedata
Eerst ingediend
9 februari 2012
Eerst ingediend dat voldeed aan de QC-criteria
9 februari 2012
Eerst geplaatst (Schatting)
13 februari 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 juli 2019
Laatste update ingediend die voldeed aan QC-criteria
20 juni 2019
Laatst geverifieerd
1 juni 2019
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 115131
- 2014-002041-22 (EudraCT-nummer)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .