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Completed

NCT Number: NCT00146172

Study Evaluating HKI-272 in 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neratinib

Drug

HKI-272

Primary outcomes

  1. Dose Limiting Toxicity (DLT)

    Time frame: 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.

  2. Maximum Tolerated Dose (MTD)

    Time frame: 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.

Secondary outcomes

  1. Number of Participants With Best Overall Response

    Time frame: 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.

  2. Duration of Response

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

    Duration of response of responders (PR+) by Kaplan-Meier estimate

  3. Progression Free Survival

    Time frame: 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.

  4. Objective Response Rate

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

    Patients with PR or higher responses, evaluable population

  5. Clinical Benefit Rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Puma Biotechnology, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 5, 2005
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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