A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
27. juni 2018 oppdatert av: Puma Biotechnology, Inc.
A Phase 1/2 Study of HKI-272 in Combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer
The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
110
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Brussels, Belgia, 1000
- Institut Jules Bordet Unite du Chimiotherapie
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Gent, Belgia, 9000
- Universitair Ziekenhuis Gent
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Kortrijk, Belgia, 8500
- AZ Groeninge Campus Maria's Voorzienigheid (MV)
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Wilrijk, Belgia, 2610
- Oncologisch Centrum GZA - Location St Augustinus
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital University Health Network
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California
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La Jolla, California, Forente stater, 92093
- Moores UC San Diego Cancer Center
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La Jolla, California, Forente stater, 92037
- Scripps, Clinic General
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San Diego, California, Forente stater, 92123
- Sharp Memorial Hospital
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Boston University Medical Center
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Michigan
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Lansing, Michigan, Forente stater, 48912
- Mid-Michigan Physicians-HOS Division
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Saint Joseph, Michigan, Forente stater, 49085
- Oncology Care Associates
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New York
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New York, New York, Forente stater, 10032
- Columbia University Medical Center
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Texas
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San Antonio, Texas, Forente stater, 78229
- CTRC at The University of Texas Health Science Center
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Hong Kong, Hong Kong
- Department of Medicine, Queen Mary Hospital
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Hong Kong, Hong Kong
- UNIMED Medical Institute
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Hong Kong, Hong Kong
- Department of Surgery Queen Mary Hospital
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Maharashtra
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Pune, Maharashtra, India, 411001
- Jehangir Clinical Development Centre, Jehangir Hospital Premises
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Pune, Maharashtra, India, 411004
- M.M.F. Joshi Hospital & Ratna Memorial Hospital
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Parel
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Mumbai, Parel, India, 400012
- Tata Memorial Hospital
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Rajasthan
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Jaipur, Rajasthan, India, 302004
- Birla Cancer Centre, S.M.S. Medical College & Hospital
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Beijing, Kina, 100021
- Cancer Hospital, Chinese Academy of Medical Sciences
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Beijing, Kina, 100032
- Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
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Beijing
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Beijing, Beijing, Kina, 100071
- The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
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Beijing, Beijing, Kina, 100853
- Chinese People's Liberation Army General Hospital
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Tianjin
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TianJin, Tianjin, Kina, 300060
- Tianjin Cancer Hospital
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Tianjin, Tianjin, Kina, 300121
- Tianjin Union Medicine Center Department of Oncology
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Seoul, Korea, Republikken, 120-752
- Yonsei University Health System - Severance Hospital
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Seoul, Korea, Republikken, 138-736
- Asan Medical Center, Division of Oncology, Department of Internal Medicine
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Krakow, Polen, 31-826
- Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera, Oddzial Onkologii
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Lublin, Polen, 20-090
- Oddzial Chemioterapii Centrum Onkologii Ziemii Lubelskiej
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Dnipropetrovsk, Ukraina, 49102
- City Multifield Clinical Hospital #4 Department of chemotherapy, Dnipropetrovs'k State Medical Academy, Chair of Oncology and Medical Radiology
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Lviv, Ukraina, 79031
- State Oncological Regional Treatment and Diagnostic Center Department of chemotherapy
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
Inclusion criteria for both parts of clinical trial:
- Good performance status
- Normal ejection fraction
- Adequate cardiac, kidney, and liver function
- Adequate blood counts
- At least one measurable target lesion
- Negative pregnancy test for female subjects
Inclusion Criteria for Part 1 Only:
- Pathologically confirmed solid tumor not curable with available standard therapy
Inclusion Criteria for Part 2 Only:
- Pathologically confirmed breast cancer
- HER2 positive tumor
- Prior treatment with Herceptin
Exclusion Criteria:
Exclusion criteria for both parts of clinical trial:
- Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1
- Subjects with bone or skin as the only site of disease
- Active central nervous system metastases
- Significant cardiac disease or dysfunction
- Significant gastrointestinal disorder
- Inability or unwillingness to swallow HKI-272 capsules
- Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2.
- Treatment with a taxane within 3 months of treatment day 1
- Grade 2 or greater motor or sensory neuropathy
- Pregnant or breast feeding women
- Known hypersensitivity to paclitaxel or Cremophor EL
- Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2
- Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
Exclusion Criteria for Part 2 Only:
- More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: HKI-272 dose level 1
Part 1: Subjects with solid tumors receiving HKI-272 (neratinib) 160 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
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Andre navn:
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Eksperimentell: HKI-272 dose level 2
Part 1: Subjects with solid tumors receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
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Andre navn:
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Eksperimentell: HKI-272 expanded MTD cohort, arm A
Part 2: Subjects with metastatic breast cancer who have not received more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
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Andre navn:
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Eksperimentell: HKI-272 expanded MTD cohort, arm B
Part 2: Subjects with metastatic breast cancer who have not received more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease receiving HKI-272 (neratinib) 240 mg daily by mouth in combination with paclitaxel 80 mg/m^2 weekly IV.
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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel
Tidsramme: From first dose date through day 28
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Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
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From first dose date through day 28
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Maximum Tolerated Dose
Tidsramme: From first dose date through day 28.
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Maximum Tolerated Dose (MTD) of neratinib, daily, in combination with paclitaxel 80 mg/m², intravenous at days 1, 8, and 15, associated with the dose limiting toxicity data.
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From first dose date through day 28.
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Objective Response Rate
Tidsramme: From first dose date to progression or last tumor assessment, up to 140 weeks
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Subjects with partial response (PR) or complete response (CR) with ERBB2 positive breast cancer treated at the maximum tolerated dose (MTD) of neratinib in combination with paclitaxel, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0:
CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and no progressive disease (PD) for non-target lesions, and no new lesions.
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From first dose date to progression or last tumor assessment, up to 140 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Maximum Plasma Concentration of Neratinib
Tidsramme: Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
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Maximum plasma concentration of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.
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Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
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Area Under the Concentration-time Curve 0-24
Tidsramme: Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
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Area under the concentration-time curve of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.
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Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. september 2007
Primær fullføring (Faktiske)
1. mai 2011
Studiet fullført (Faktiske)
7. februar 2018
Datoer for studieregistrering
Først innsendt
8. mars 2007
Først innsendt som oppfylte QC-kriteriene
8. mars 2007
Først lagt ut (Anslag)
9. mars 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juli 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juni 2018
Sist bekreftet
1. juni 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 3144A1-203 / B1891014
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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