Dasatinib and Lapatinib Ditolsylate in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery

NCT00662636 | Completed Phase 1

• 3 other identifiers: MC0616NCI-2009-01197P30CA015083
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Dasatinib and lapatinib ditoslylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib and lapatinib ditoslylate when given together in treating patients with advanced solid tumors that cannot be removed by surgery.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (6)

• Adverse events profile

• Toxicity profile per NCI CTCAE v3.0

• Response profile

  Every 4 weeks

• Time until any treatment-related toxicity, time until treatment-related grade 3+ toxicity, and time until hematologic nadirs (WBC, ANC, platelets)

• Time to progression and time to treatment failure

• Laboratory correlates

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral dasatinib and lapatinib ditosylate once daily on days 1-28.

Drug: dasatinib; Drug: lapatinib ditosylate; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

dasatinib DRUG

Given orally

Also known as: BMS-354825, Sprycel

Arm I

lapatinib ditosylate DRUG

Given orally

Also known as: GSK572016, GW-572016, GW2016, Lapatinib, Tykerb

Arm I

pharmacological study OTHER

Correlative study (cohort II only)

Also known as: pharmacological studies

Arm I

laboratory biomarker analysis OTHER

Correlative study (cohort II only)

Arm I

Eligibility Criteria

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

You may qualify if:

• Histologic proof of cancer that is now unresectable and refractory to or refused all standard treatment for the disease
• Please contact study investigator and/or consult protocol document for specific details on laboratory criteria
• Ability to provide informed consent
• Willingness to return to Mayo Clinic for follow up
• Life expectancy \>= 12 weeks
• Negative serum pregnancy test done =\< 7 days prior to registration for women of childbearing potential only
• Echocardiogram with ejection fraction \> 50%
• ECOG performance status (PS) 0-2
• Able to swallow pills whole (patients with feeding tubes may be eligible if whole pills can be taken and tolerated through the feeding tube)
• Willingness to provide the biologic specimens as required by the protocol for Cohort II, (MTD) patients only

You may not qualify if:

• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
• Pregnant women
• Any of the following prior therapies: chemotherapy =\< 4 weeks prior to registration; mitomycin C/nitrosoureas =\< 6 weeks prior to registration; immunotherapy =\< 4 weeks prior to registration; biologic therapy =\< 4 weeks prior to registration
• Patients who have been treated with Avastin, Herceptin, or Erbitux are eligible if last treatment is \>= 4 weeks; molecularly targeted agents (erlotinib, sunitinib, sorafenib, gefitinib, imatinib) =\< 4 weeks prior to registration; radiation therapy =\< 4 weeks prior to registration; radiation to \> 25% of bone marrow
• CNS metastases that are not stable for at least 4 weeks prior to registration based on imaging, clinical assessment, and use of steroids
• Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and until 4 weeks following study
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
• Current therapy with a CYP3A4 inhibitor or inducer
• Known standard therapy for the patient's disease that is not refractory to treatment that is potentially curative or definitely capable of extending life expectancy
• Uncontrolled pleural or pericardial effusion of any grade
• Uncontrolled angina, congestive heart failure or MI within 6 months prior to registration
• Diagnosed congenital long QT syndrome
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
• Prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec)
• Subjects with potassium or magnesium that are not within normal limits and cannot be corrected prior to registration

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Dasatinib; Lapatinib; N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl-6-(5-((methylsulfonyl)ethyl)aminomethyl)-2-furyl)-4-quinazolinamine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Charles Erlichman

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 21, 2008
• Study Start: August 1, 2008
• Primary Completion: December 18, 2014
• Study Completion: December 18, 2014
• Last Updated: March 23, 2017

Record last verified: 2016-04

Locations

US (3)