Study Evaluating HKI-272 in Tumors
17. august 2018 opdateret af: Puma Biotechnology, Inc.
An Ascending Single and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Subjects With HER-2/NEU or HER-1/EGFR-Positive Tumors
The purpose of this study is to evaluate the safety and tolerability as well as find the maximum tolerated dose (MTD) for HKI-272.
In addition, this study will examine the effects of the study drug on your tumor, and how your body uses and eliminates HKI-272.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
73
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Florida
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Tampa, Florida, Forenede Stater, 33612
- H. Lee Moffitt Cancer Center & Research Institute
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
-
-
Missouri
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Saint Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
-
-
Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- The Cleveland Clinic Foundation Taussig Cancer Center
-
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- The Sarah Cannon Cancer Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Her2/neu or Her1/EGFR positive cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Exclusion Criteria:
- Prior treatment with anthracyclines with a cumulative dose of doxorubicin or equivalent of greater than 300 mg/m^2
- Patients with significant cardiac risk factors
- Active central nervous system metastasis
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Neratinib 80 mg
|
HKI-272
|
|
Eksperimentel: Neratinib 240 mg
|
HKI-272
|
|
Eksperimentel: Neratinib 320 mg
|
HKI-272
|
|
Eksperimentel: Neratinib 40 mg
|
HKI-272
|
|
Eksperimentel: Neratinib 120 mg
|
HKI-272
|
|
Eksperimentel: Neratinib 180 mg
|
HKI-272
|
|
Eksperimentel: Neratinib 400 mg
|
HKI-272
|
|
Eksperimentel: Neratinib 320 mg MTD
|
HKI-272
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dose Limiting Toxicity (DLT)
Tidsramme: From first dose date to day 14
|
DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0.
DLTs were assessed from the first single dose to 14 days of continuous daily administration.
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From first dose date to day 14
|
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Maximum Tolerated Dose (MTD)
Tidsramme: From first dose date to day 14
|
If 2 or more, of 3 to 6 subjects, at a dose level had an neratinib-related dose limiting toxicity (DLT) by day 14 of continuous daily dose administration, dose escalation stopped and the prior dose level was considered the MTD.
|
From first dose date to day 14
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Best Overall Response
Tidsramme: From first dose date to progression or last tumor assessment, up to 39 weeks.
|
Best Overall response by tumor type, evaluable population per Response Evaluation Criteria In Solid Tumors Criteria v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (LD) of target lesions in reference to baseline sum of LD of target lesions; Progressive Disease (PD), >=20% increase in sum of LD of target lesions, taking as reference the smallest sum of recorded LD of target lesions since treatment started or appearance of 1 or more new lesions; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD of target lesions since the treatment start.
The best overall response was the best response recorded from start of treatment until PD/recurrence.
In general, the subject's best response assignment depended on achievement of both measurement and confirmation criteria.
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From first dose date to progression or last tumor assessment, up to 39 weeks.
|
|
Duration of Response
Tidsramme: From start date of response to first PD, up to 39 weeks.
|
Duration of response of responders (PR+) by Kaplan-Meier estimate
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From start date of response to first PD, up to 39 weeks.
|
|
Progression Free Survival
Tidsramme: From first dose date to progression or death, up to 39 weeks.
|
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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From first dose date to progression or death, up to 39 weeks.
|
|
Objective Response Rate
Tidsramme: From first dose date to progression/death or last assessment, up to 39 weeks
|
Patients with PR or higher responses, evaluable population
|
From first dose date to progression/death or last assessment, up to 39 weeks
|
|
Clinical Benefit Rate
Tidsramme: From first dose date to progression/death or last assessment, up to 39 weeks.
|
Patients with PR or higher responses or SD>=24 weeks, evaluable population
|
From first dose date to progression/death or last assessment, up to 39 weeks.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2003
Primær færdiggørelse (Faktiske)
1. januar 2007
Studieafslutning (Faktiske)
1. januar 2007
Datoer for studieregistrering
Først indsendt
2. september 2005
Først indsendt, der opfyldte QC-kriterier
2. september 2005
Først opslået (Skøn)
5. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. august 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3144A1-102
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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