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Clear Cell Renal Cell CarcinomaPhase 2NCT00408902

Tandutinib in Treating Patients Who Have Undergone Surgery for Metastatic Kidney Cancer

A Phase 2 study testing tandutinib and laboratory biomarker analysis in people with Clear Cell Renal Cell Carcinoma and Recurrent Renal Cell Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying how well tandutinib works in treating patients who have undergone surgery for metastatic kidney cancer. Tandutinib may stop the growth of kidney cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
tandutinib and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Nov 2006to Dec 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically confirmed RCC of clear cell histology; subjects must have a component of conventional clear cell RCC with or without sarcomatoid features
  • Patients must have evidence of metastatic disease and must have had a cytoreductive nephrectomy at least 28 days prior to first day of treatment
  • Archival tissue from nephrectomy must be available for correlative studies
  • Patients must have measurable disease, defined by RECIST criteria
  • Patients must have received at least one prior FDA approved therapy for metastatic renal cell carcinoma with either Sutent, or Nexavar, and may have received up to three prior systemic therapies for metastatic disease; prior cytokine therapy is also permitted
  • Prior systemic therapy with other antiangiogenic agents such as Thalidomide, Bevacizumab, or AG013736 is permitted
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  • Patients must have a life expectancy of >= 3 months
  • Patients must have an ECOG performance status of 0-1 (Karnofsky >= 70%)
  • Patients must be at least 4 weeks from radiation therapy and recovered from all related toxicity
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 8.5 g/dl
  • Total Bilirubin =< 1.5 X institutional upper limit of normal
  • AST (SGOT)/ALT (SGPT) =< 3.5 X institutional upper limit of normal
  • Alkaline phosphatase =< 2.5 ULN (=< 10 x ULN in presence of bone metastasis)
  • Serum calcium of =< 12 mg/dl
  • Creatinine =< 1.5 X institutional upper limit of normal
  • INR =< 1.5, except for subjects receiving warfarin therapy; for subjects who are receiving warfarin for prophylaxis or treatment of thrombosis, INR values should be carefully monitored while patients are on study
  • Electrocardiogram (12-lead) with cQTC < 500 msec using the Bazett's formula
  • Absence of significant effusions and/or ascites
  • No major surgery requiring general anesthesia within the past 28 days
  • Patients may not have had brain metastasis
  • Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of MLN518 will be determined following review of their case by the Principal Investigator; because MLN518 is a substrate of the P-glycoprotein (P-gp) drug efflux pump, co- administration of agents that inhibit or induce this mechanism may alter exposure to MLN518
  • The effects of MLN518 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because receptor tyrosine kinase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; sexually active patients must continue to use contraception for three months after completion of study therapy
  • All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines; a copy of the informed consent document signed by the patient must be given to the patient

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients may not be receiving any other investigational agents
  • Patients may not be co-medicated with an agent that causes QTc prolongation
  • Patients with a mean QTc > 500 msec using the Bazett's formula taken from the screening electrocardiogram or history of familial long QT syndrome are ineligible
  • Left ventricular ejection fraction (LVEF) < 40%
  • Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
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  • Ongoing vomiting, or nausea >= grade 2 (NCI CTCAE v3.0)
  • Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow pills or absorb oral medications are excluded
  • Known or suspected primary muscular or neuromuscular disease (e.g., muscular dystrophy, myasthenia gravis)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN518 such as Tarceva™, Iressa® and Cardura® XL
  • Patients with any CNS metastases or uncontrolled seizure disorder
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements
  • Any malignancy other than a renal cell carcinoma, with the following exceptions:
  • Basal or squamous cell carcinomas of the skin
  • Carcinoma in-situ of the uterine cervix
  • Any malignancy treated with curative intent and in complete remission for > 3 years
  • Patients with organ allografts
  • Patients with non-clear cell carcinoma i.e., papillary, collecting duct, or chromophobe
  • Pregnant women are excluded from this study because MLN518 is a receptor tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MLN518, breastfeeding should be discontinued if the mother is treated with MLN518
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MLN518; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
  • Inability to comply with study and/or follow-up procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Case Western Reserve University

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Phase II Study of MLN518 in Patients With Metastatic Clear Cell Renal Cell Carcinoma

This phase II trial is studying how well tandutinib works in treating patients who have undergone surgery for metastatic kidney cancer. Tandutinib may stop the growth of kidney cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving tandutinib after surgery may kill any tumor cells that remain after surgery.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the overall efficacy of MLN518 in patients with metastatic clear cell renal carcinoma.

SECONDARY OBJECTIVES:

  1. To evaluate the effect of MLN518 on progression-free survival and overall survival in patients with metastatic clear cell renal carcinoma.

II. To evaluate the toxicity of MLN518 in patients with metastatic clear cell renal carcinoma.

III. To evaluate the effects of MLN518 on serum VEGF-A, VEGF-R2, PIGF, and PDGF levels of patients with metastatic renal cell carcinoma receiving MLN518.

IV. To determine the VHL gene status, methylation, and pVHL in archived material from the primary nephrectomy specimen of patients receiving MLN518.

  1. To evaluate tumor blood flow and vessel permeability based on functional imaging with dynamic contrast enhanced magnetic resonance imaging (dceMRI) in metastatic renal cell carcinoma patients treated with MLN518.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks.

Being tested
tandutinib, laboratory biomarker analysis
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tandutinibDrug

    Also called CT53518, MLN518

    Given orally, 500 mg bid daily

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00408902
Study groupRoleWhat they receive
TandutinibTreatmentExperimentalPatients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: tandutinib; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Efficacy, Taking Into Account Both Objective Response and Meaningful Reductions in Tumor Burden That do Not Meet the RECIST Criteria for PR or CR (e.g., 5-30% Reduction in RECIST Defined Tumor Burden)

    The number of patients that reach complete response (CR)defined as the disappearance of all target lesions or partial response (PR)defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

    Measured: Up to 4 weeks after completion of study treatment

Secondary outcomes (2)

  1. Overall Survival

    Estimated using the method of Kaplan and Meier.

    Measured: Followed until progression or death for approximately 3 years

  2. Progression-free Survival

    Estimated time to progression using the method of Kaplan and Meier.

    Measured: Up to 4 weeks after completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionOct 2008
  4. Study completionDec 2008

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00408902
Sponsor's protocol ID
NCI-2012-03014
Other IDs
CASE 10805, CDR0000518799, U01CA062502
Status last verified
Oct 2017
First submitted
6 Dec 2006
Last updated
22 Nov 2017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tandutinib and laboratory biomarker analysis in people with Clear Cell Renal Cell Carcinoma and Recurrent Renal Cell Cancer, run by National Cancer Institute (NCI) at 1 site 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 25 inclusion and 21 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 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Efficacy, Taking Into Account Both Objective Response and Meaningful Reductions in Tumor Burden That do Not Meet the RECIST Criteria for PR or CR (e.g., 5-30% Reduction in RECIST Defined Tumor Burden) (time frame: Up to 4 weeks after completion of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00408902.

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 22 Nov 2017.

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