Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00662636
Dasatinib and Lapatinib Ditolsylate in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery
A Phase 1 study testing dasatinib, lapatinib ditosylate and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Mayo Clinic at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- dasatinib, lapatinib ditosylate and pharmacological study
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2008to 18 Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- New York Heart Association classification III or IV
- Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
- Ongoing or recent (=< 3 months prior to registration) significant gastrointestinal bleeding
- Prophylactic use of colony-stimulating factors during the study is not allowed
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
- G.I conditions that may interfere with drug absorption such as Ulcerative Colitis, Crohn's Disease, and Short Bowel Syndrome
- Active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator's assessment)
- Nursing women
- Uncontrolled infection
- Seizure disorder
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Phase I Trial of the Combination of Dasatinib and Lapatinib
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximally tolerated dose of dasatinib combined with lapatinib.
II. To describe the toxicities associated with this treatment combination. III. To assess the pharmacokinetic interaction of lapatinib and dasatinib. IV. To assess the effect of the lapatinib and dasatinib combination on circulating tumor cells and on osteoclast precursor activation.
- To study the association of clinical (toxicity and/or tumor response or activity) with the pharmacokinetic parameters, and/or biologic (pharmacodynamic) results.
VI. To describe the responses of this treatment combination.
OUTLINE: This is a multicenter, phase I, dose-escalation study. COHORT I: Patients receive oral dasatinib and oral lapatinib ditosylate once daily on days 1-28.
COHORT II: Patients receive oral dasatinib once daily on days 1 and 9-28 and oral lapatinib ditosylate once daily on days 2-28 of course 1. In all subsequent courses patients receive oral dasatinib and oral lapatinib ditosylate once daily on days 1-28.
In both cohorts courses repeat every 28 days, in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 3 months.
- Being tested
- dasatinib, lapatinib ditosylate, pharmacological study, laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dasatinibDrug
Also called BMS-354825, Sprycel
Given orally
lapatinib ditosylateDrug
Also called GSK572016, GW-572016, GW2016, Lapatinib
Given orally
Also called pharmacological studies
Correlative study (cohort II only)
laboratory biomarker analysisOther
Correlative study (cohort II only)
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral dasatinib and lapatinib ditosylate once daily on days 1-28. Receives: Drug: dasatinib; Drug: lapatinib ditosylate; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events profile
Toxicity profile per NCI CTCAE v3.0
Response profile
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startAug 2008
- Primary completion18 Dec 2014
- Study completion18 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles Erlichman, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662636
- Sponsor's protocol ID
- MC0616
- Other IDs
- NCI-2009-01197, MC0616, P30CA015083
- Status last verified
- Apr 2016
- First submitted
- 18 Apr 2008
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of the Combination of Dasatinib and Lapatinib
- ClinicalTrials.gov ID
- NCT00662636
- Acronym / sponsor ID
- MC0616
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008 (actual)
- Primary completion
- 18 Dec 2014 (actual)
- Study completion
- 18 Dec 2014 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximally tolerated dose of dasatinib combined with lapatinib.
II. To describe the toxicities associated with this treatment combination. III. To assess the pharmacokinetic interaction of lapatinib and dasatinib. IV. To assess the effect of the lapatinib and dasatinib combination on circulating tumor cells and on osteoclast precursor activation.
- To study the association of clinical (toxicity and/or tumor response or activity) with the pharmacokinetic parameters, and/or biologic (pharmacodynamic) results.
VI. To describe the responses of this treatment combination.
OUTLINE: This is a multicenter, phase I, dose-escalation study. COHORT I: Patients receive oral dasatinib and oral lapatinib ditosylate once daily on days 1-28.
COHORT II: Patients receive oral dasatinib once daily on days 1 and 9-28 and oral lapatinib ditosylate once daily on days 2-28 of course 1. In all subsequent courses patients receive oral dasatinib and oral lapatinib ditosylate once daily on days 1-28.
In both cohorts courses repeat every 28 days, in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: dasatinib, Drug: lapatinib ditosylate, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive oral dasatinib and lapatinib ditosylate once daily on days 1-28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dasatinibAlso: BMS-354825, SprycelGiven orally | Drug | Arm I |
| lapatinib ditosylateAlso: GSK572016, GW-572016, GW2016, LapatinibGiven orally | Drug | Arm I |
| pharmacological studyAlso: pharmacological studiesCorrelative study (cohort II only) | Other | Arm I |
| laboratory biomarker analysisCorrelative study (cohort II only) | Other | Arm I |
Primary outcome
Adverse events profile
Toxicity profile per NCI CTCAE v3.0
Response profile
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Erlichman principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dasatinib, lapatinib ditosylate and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events profile. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.