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Study of TAK-733 in Adult Patients With Advanced Nonhematologic Malignancies

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ClinicalTrials.gov Identifier: NCT00948467
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE July 27, 2009
First Posted Date  ICMJE July 29, 2009
Last Update Posted Date July 2, 2013
Study Start Date  ICMJE December 2009
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2009)
  • Safety profile, dose-limiting toxicities, maximum tolerated dose and recommended phase 2 dose of TAK-733 [ Time Frame: 12 months ]
  • Pharmacokinetic characterization of TAK-733 [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2009)
  • Effect of food on the pharmacokinetics of TAK-733 [ Time Frame: 12 months ]
  • Antitumor activity of TAK-733 in patients with advanced nonhematologic malignancies [ Time Frame: 12 months ]
  • Antitumor activity of TAK-733 in melanoma patients [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TAK-733 in Adult Patients With Advanced Nonhematologic Malignancies
Official Title  ICMJE A Multicenter, Open-label, Dose-escalation, Phase I Study of TAK-733, an Oral MEK Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies
Brief Summary The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and maximum tolerated dose of TAK-733 in patients with advanced, nonhematologic tumors. The expansion stage of the study will evaluate evidence of antitumor activity of TAK-733 in patients with advanced metastatic melanoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Non-hematologic Malignancies
  • Advanced Metastatic Melanoma
Intervention  ICMJE Drug: TAK-733

The Initial Escalation Stage will enroll approximately 30 patients with advanced nonhematologic malignancies. TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days.

The Expansion Stage will enroll approximately 30 patients with advanced metastatic melanoma. The recommended phase 2 dose determined in the Initial Escalation Stage of TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days.

Study Arms  ICMJE Experimental: TAK-733
Intervention: Drug: TAK-733
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2013)
51
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2009)
60
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • 18 years or older.
  • Have one of the following diagnoses: a nonhematologic malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective; OR have stage 3 or stage 4 unresectable melanoma not priorly treated with either MEK or BRAF inhibitor therapy.
  • Melanoma patients should have the V600E BRAF mutation status of their tumor documented, if available, and tumor tissue must be provided for confirmatory genotyping by a central laboratory.
  • Have a radiographically or clinically evaluable tumor.
  • Have suitable venous access for the conduct of blood sampling.
  • Provide voluntary written consent, which can be withdrawn by the patient at any time.
  • Female patients who: are post-menopausal for at least 1 year before screening; OR are surgically sterile; OR if they are of childbearing potential agree to practice two effective methods of birth control from the time of signing the informed consent form through 30 days after the last dose of the study drug, or agree to completely abstain from heterosexual intercourse.
  • Male patients, even if surgically sterilized, must agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of the study drug; OR agree to completely abstain from heterosexual intercourse.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Female patients who are lactating or have a positive serum pregnancy test during the Screening period.
  • Antineoplastic therapy or radiotherapy within 21 days; or nitrosoureas of mitomycin C within 42 days
  • Prior biologic or immunotherapy ≤ 4 weeks prior to enrollment.
  • Grade 2 or greater unresolved toxicity (except alopecia) from previous anticancer therapy.
  • Major surgery within 14 days of the first dose of the study drug.
  • An active infection requiring systemic therapy; or other severe infection.
  • Symptomatic brain metastases.
  • Inability to meet specific laboratory test standards during the Screening period as specified in the study protocol.
  • Human Immunodeficiency (HIV) positive.
  • Hepatitis B surface antigen positive or active hepatitis C infection.
  • Serious medical or psychiatric illness likely to interfere with the study.
  • Uncontrolled cardiovascular condition.
  • Abnormalities on 12-lead ECG performed within 28 days before the start of the study drug that are considered to be clinically significant or rate corrected QT interval > 470 milliseconds.
  • Melanoma patients will be excluded if they have had a diagnosis with or treatment for another malignancy within 2 years of the first dose of the study drug, or have been previously diagnosed with another malignancy with any evidence of residual disease.
  • Treatment with any investigational product within 28 days before the first dose of the study drug.
  • A history of an ongoing or newly diagnosed eye abnormality, such as retinal or corneal pathologies.
  • Abnormal left ventricular ejection fraction (LVEF).
  • Receiving therapeutic anticoagulation
  • Treatment with any of the following strong CYP3A inhibitors or inducers within 14 days before the first dose of study drug: ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, rifampin, rifapentine, or rifabutin.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00948467
Other Study ID Numbers  ICMJE C20001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Millennium Pharmaceuticals, Inc.
Study Sponsor  ICMJE Millennium Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
PRS Account Millennium Pharmaceuticals, Inc.
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP