Study Evaluating HKI-272 in Tumors

NCT00146172 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 3144A1-102
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Breast Neoplasms

Keywords

Tumors; Neratinib; HKI-272; Nerlynx

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT)

  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.

  From first dose date to day 14

• Maximum Tolerated Dose (MTD)

  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

Secondary Outcomes (5)

• Number of Participants With Best Overall Response

  From first dose date to progression or last tumor assessment, up to 39 weeks.

• Duration of Response

  From start date of response to first PD, up to 39 weeks.

• Progression Free Survival

  From first dose date to progression or death, up to 39 weeks.

• Objective Response Rate

  From first dose date to progression/death or last assessment, up to 39 weeks

• Clinical Benefit Rate

  From first dose date to progression/death or last assessment, up to 39 weeks.

Study Arms (8)

Neratinib 40 mg

EXPERIMENTAL

Drug: neratinib

Neratinib 80 mg

EXPERIMENTAL

Drug: neratinib

Neratinib 120 mg

EXPERIMENTAL

Drug: neratinib

Neratinib 180 mg

EXPERIMENTAL

Drug: neratinib

Neratinib 240 mg

EXPERIMENTAL

Drug: neratinib

Neratinib 320 mg

EXPERIMENTAL

Drug: neratinib

Neratinib 400 mg

EXPERIMENTAL

Drug: neratinib

Neratinib 320 mg MTD

EXPERIMENTAL

Drug: neratinib

Interventions

neratinib DRUG

HKI-272

Neratinib 120 mg; Neratinib 180 mg; Neratinib 240 mg; Neratinib 320 mg; Neratinib 320 mg MTD; Neratinib 40 mg; Neratinib 400 mg; Neratinib 80 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Puma Biotechnology, Inc.: lead

Study Sites (5)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The Cleveland Clinic Foundation Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

The Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

neratinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Director, Clinical Operations
• Organization: Puma Biotechnology, Inc.

clinicaltrials@pumabiotechnology.com

+1 (424) 248-6500

Study Officials

• Puma

  Biotechnology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This trial was an open-label, phase 1, ascending single and multiple oral dose study of HKI-272 administered to subjects with erbB-2- or erbB-1-positive tumors. Each subject participated in only 1 dose group and received a single dose of test article, followed by a 1-week observation period, and then received the test article administered once daily by mouth for up to 6 months (6 cycles). Daily dose administration could continue beyond 6 cycles at the same dose level if HKI-272 was well tolerated and there was no evidence of progressive disease.

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: November 1, 2003
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: September 17, 2018
• Results First Posted: February 13, 2018

Record last verified: 2018-08

Locations

US (5)