- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01531894
Continuation Study of the Oral AKT Inhibitor GSK2110183
An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Hematologic Malignancies
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Victoria
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Melbourne, Victoria, Australien, 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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Maryland
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Baltimore, Maryland, Forenede Stater, 21231
- Novartis Investigative Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Novartis Investigative Site
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New York
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New York, New York, Forenede Stater, 10029
- Novartis Investigative Site
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New York, New York, Forenede Stater, 10065
- Novartis Investigative Site
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Galway, Irland
- Novartis Investigative Site
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Seoul, Korea, Republikken, 110-744
- Novartis Investigative Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants With at Least One Adverse Events (AEs)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 115131
- 2014-002041-22 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med GSK2110183 (afuresertib)
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GlaxoSmithKlineAfsluttetLangerhans cellehistiocytoseForenede Stater
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GlaxoSmithKlineAfsluttet
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Novartis PharmaceuticalsAfsluttetNeoplasmer, hæmatologiskeJapan
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NovartisAmgenAfsluttet
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University Health Network, TorontoNovartisAfsluttet
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Laekna LimitedAfsluttet
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GlaxoSmithKlineTrukket tilbage
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GlaxoSmithKlineAfsluttet
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Laekna LimitedAktiv, ikke rekrutterendeMetastatisk kastrationsresistent prostatakræftForenede Stater, Korea, Republikken
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Laekna LLCAktiv, ikke rekrutterende