Completed

A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Trastuzumab [Herceptin†]

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What is being tested

Data Collection

Who is being recruted

Breast Diseases
+2

+ Breast Neoplasms
+ Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the optimally tolerated regimen of GW572016 when administered with trastuzumab (Herceptin\^®) in patients with metastatic breast cancer that overexpresses HER2/neu. * Determine the safety and tolerability of this regimen in these patients. Secondary * Determine the pharmacokinetic parameters of this regimen in these patients. * Determine the clinical response in patients treated with this regimen. OUTLINE: This is an open-label, multicenter, dose-escalation study of GW572016. Patients receive oral GW572016 once daily on days 1-28 and trastuzumab (Herceptin\^®) IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of GW572016 until the optimally tolerated regimen (OTR) is determined. The OTR is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the OTR is determined, 10-18 additional patients are entered and treated at the OTR. Patients are followed at 28 days. PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.

Official TitleA Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Trastuzumab [Herceptin†] 
NCT00085020
Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
13 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Diseases
Breast Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases
Criteria

Inclusion Criteria: * Histologically or cytologically confirmed breast cancer * Metastatic disease * Measurable or evaluable disease * HER2/neu overexpression (2+ or 3+) confirmed by immunohistochemistry and/or HER2 gene amplification by fluorescence in situ hybridization * Brain metastases treated by surgery and/or radiotherapy allowed provided the following criteria are met: * Neurologic status stable 2 weeks after discontinuing dexamethasone * No concurrent anticonvulsants that induce metabolism (e.g., phenytoin, carbamazepine, or phenobarbital) * 18 and over * Male or female * Karnofsky 70-100% * Life expectancy, At least 12 weeks * Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if patient has liver metastases) * Bilirubin \< 1.5 mg/dL * Creatinine clearance \> 30 mL/min * Cardiovascular * LVEF \> 50% * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after study participation * Adequate venous access * Able to swallow and retain oral medication * Prior adjuvant/neoadjuvant chemotherapy allowed * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin. * More than 4 weeks since prior radiotherapy * More than 4 weeks since prior major surgery * Recovered from all prior therapy * More than 28 days since prior participation in another investigational study * More than 28 days since prior investigational drugs Exclusion Criteria: * extensive tumor, pleural effusions, or parenchymal masses) resulting in dyspnea at rest * uncontrolled brain metastases or leptomeningeal disease * prior myocardial infarction * pre-existing cardiac dysfunction (e.g., congestive heart failure) * clinically significant cardiac disease * angina pectoris * symptomatic intrinsic pulmonary disease (e.g., asthma or chronic obstructive pulmonary disease) resulting in dyspnea at rest * pregnant or nursing * active infection * known hypersensitivity to Chinese Hamster Ovary cell proteins or any component of this product * known immediate or delayed hypersensitivity reaction or idiosyncrasy to products of similar chemical composition as study drug * known contraindications to trastuzumab (Herceptin\^®) * malabsorption syndrome * disease significantly affecting gastrointestinal function * psychiatric disorder that would preclude study compliance * other serious illness or condition * concurrent biologic therapy * prior cumulative dose of doxorubicin \> 400 mg/m\^2 (including liposomal doxorubicin) * concurrent hormonal therapy\* * concurrent glucocorticoids * concurrent radiotherapy * prior major resection of the stomach or small bowel that could affect absorption of GW572016 * concurrent cytotoxic therapy * other concurrent anticancer therapy * other concurrent investigational drugs during and for 28 days after study treatment * concurrent administration of any of the following medications or substances: * Antibiotics * Clarithromycin * Erythromycin * Troleandomycin * Ciprofloxacin * Rifampin * Norfloxacin * Rifabutin * HIV antivirals * Delaviridine * Indinavir * Nelfinavir * Ritonavir * Saquinavir * Efavirenz * Nevirapine * Amprenavir * Lopinavir * Anticonvulsants * Phenytoin * Carbamazepine * Phenobarbital * Antidepressants * Fluoxetine * Nefazodone * Fluvoxamine * Antifungals * Itraconazole * Ketoconazole * Fluconazole * Voriconazole * Antacids (within 1 hour before and after study drug administration) * Cimetidine * Amiodarone * Diltiazem * Pioglitazone * Hypericum perforatum (St. John's wort) * Grapefruit or grapefruit juice * Rifabutin * Diethyldithiocarbamate * Gestodene * Mifepristone * Modafinil



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Jonsson Comprehensive Cancer Center, UCLALos Angeles, United StatesSee the location

CompletedOne Study Center
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