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Trial record 10 of 55 for:    hki-272 OR neratinib

A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

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ClinicalTrials.gov Identifier: NCT00445458
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : May 9, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Advanced Malignant Solid Tumors Breast Neoplasms Drug: HKI-272 Drug: Paclitaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of HKI-272 in Combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer
Actual Study Start Date : September 11, 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : February 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: HKI-272
Other Name: Neratinib

Drug: Paclitaxel
Experimental: 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.
Drug: HKI-272
Other Name: Neratinib

Drug: Paclitaxel
Experimental: 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.
Drug: HKI-272
Other Name: Neratinib

Drug: Paclitaxel
Experimental: 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.
Drug: HKI-272
Other Name: Neratinib

Drug: Paclitaxel



Primary Outcome Measures :
  1. Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel [ Time Frame: From first dose date through day 28 ]
    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.

  2. Maximum Tolerated Dose [ Time Frame: From first dose date through day 28. ]
    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.

  3. Objective Response Rate [ Time Frame: From first dose date to progression or last tumor assessment, up to 140 weeks ]
    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.


Secondary Outcome Measures :
  1. Maximum Plasma Concentration of Neratinib [ Time Frame: 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. ]
    Maximum plasma concentration of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.

  2. Area Under the Concentration-time Curve 0-24 [ Time Frame: 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. ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445458


  Hide Study Locations
Locations
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United States, California
Scripps, Clinic General
La Jolla, California, United States, 92037
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Mid-Michigan Physicians-HOS Division
Lansing, Michigan, United States, 48912
Oncology Care Associates
Saint Joseph, Michigan, United States, 49085
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Texas
CTRC at The University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Belgium
Institut Jules Bordet Unite du Chimiotherapie
Brussels, Belgium, 1000
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
AZ Groeninge Campus Maria's Voorzienigheid (MV)
Kortrijk, Belgium, 8500
Oncologisch Centrum GZA - Location St Augustinus
Wilrijk, Belgium, 2610
Canada, Ontario
Princess Margaret Hospital University Health Network
Toronto, Ontario, Canada, M5G 2M9
China, Beijing
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing, Beijing, China, 100071
Chinese People's Liberation Army General Hospital
Beijing, Beijing, China, 100853
China, Tianjin
Tianjin Cancer Hospital
TianJin, Tianjin, China, 300060
Tianjin Union Medicine Center Department of Oncology
Tianjin, Tianjin, China, 300121
China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, China, 100032
Hong Kong
UNIMED Medical Institute
Hong Kong, Hong Kong, 0
Department of Medicine, Queen Mary Hospital
Hong Kong, Hong Kong
Department of Surgery Queen Mary Hospital
Hong Kong, Hong Kong
India
Jehangir Clinical Development Centre, Jehangir Hospital Premises
Pune, Maharashtra, India, 411001
M.M.F. Joshi Hospital & Ratna Memorial Hospital
Pune, Maharashtra, India, 411004
Tata Memorial Hospital
Mumbai, Parel, India, 400012
Birla Cancer Centre, S.M.S. Medical College & Hospital
Jaipur, Rajasthan, India, 302004
Korea, Republic of
Yonsei University Health System - Severance Hospital
Seoul, Korea, Republic of, 120-752
Asan Medical Center, Division of Oncology, Department of Internal Medicine
Seoul, Korea, Republic of, 138-736
Poland
Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera, Oddzial Onkologii
Krakow, Poland, 31-826
Oddzial Chemioterapii Centrum Onkologii Ziemii Lubelskiej
Lublin, Poland, 20-090
Ukraine
City Multifield Clinical Hospital #4 Department of chemotherapy, Dnipropetrovs'k State Medical Academy, Chair of Oncology and Medical Radiology
Dnipropetrovsk, Ukraine, 49102
State Oncological Regional Treatment and Diagnostic Center Department of chemotherapy
Lviv, Ukraine, 79031
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
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Study Director: Puma Biotechnology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00445458     History of Changes
Other Study ID Numbers: 3144A1-203 / B1891014
First Posted: March 9, 2007    Key Record Dates
Results First Posted: May 9, 2018
Last Update Posted: July 25, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Puma Biotechnology, Inc.:
cancer
HKI-272
neratinib
paclitaxel
Taxol
breast cancer
Nerlynx

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action