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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
110
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Brussels, Belgien, 1000
- Institut Jules Bordet Unite du Chimiotherapie
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Gent, Belgien, 9000
- Universitair Ziekenhuis Gent
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Kortrijk, Belgien, 8500
- AZ Groeninge Campus Maria's Voorzienigheid (MV)
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Wilrijk, Belgien, 2610
- Oncologisch Centrum GZA - Location St Augustinus
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California
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La Jolla, California, Förenta staterna, 92093
- Moores UC San Diego Cancer Center
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La Jolla, California, Förenta staterna, 92037
- Scripps, Clinic General
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San Diego, California, Förenta staterna, 92123
- Sharp Memorial Hospital
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02118
- Boston University Medical Center
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Michigan
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Lansing, Michigan, Förenta staterna, 48912
- Mid-Michigan Physicians-HOS Division
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Saint Joseph, Michigan, Förenta staterna, 49085
- Oncology Care Associates
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New York
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New York, New York, Förenta staterna, 10032
- Columbia University Medical Center
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Texas
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San Antonio, Texas, Förenta staterna, 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, Indien, 411001
- Jehangir Clinical Development Centre, Jehangir Hospital Premises
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Pune, Maharashtra, Indien, 411004
- M.M.F. Joshi Hospital & Ratna Memorial Hospital
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Parel
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Mumbai, Parel, Indien, 400012
- Tata Memorial Hospital
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Rajasthan
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Jaipur, Rajasthan, Indien, 302004
- Birla Cancer Centre, S.M.S. Medical College & Hospital
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Ontario
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Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Hospital University Health Network
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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, Republiken av, 120-752
- Yonsei University Health System - Severance Hospital
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Seoul, Korea, Republiken av, 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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Andra namn:
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Experimentell: 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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Andra namn:
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Experimentell: 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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Andra namn:
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Experimentell: 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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Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Maximum Plasma Concentration of Neratinib
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 september 2007
Primärt slutförande (Faktisk)
1 maj 2011
Avslutad studie (Faktisk)
7 februari 2018
Studieregistreringsdatum
Först inskickad
8 mars 2007
Först inskickad som uppfyllde QC-kriterierna
8 mars 2007
Första postat (Uppskatta)
9 mars 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 juli 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juni 2018
Senast verifierad
1 juni 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 3144A1-203 / B1891014
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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