A Safety and Pharmacokinetic Study of TAK-285 in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00535522
First received: September 21, 2007
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to determine the safety and pharmacokinetics of TAK-285 in patients with advanced cancer.


Condition Intervention Phase
Cancer
Drug: TAK-285 Dose Escalation Cohorts
Drug: TAK-285 Recommended Phase 2 Dosing Cohort
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Noncomparative Phase I Clinical and Pharmacokinetic Study of Oral TAK-285 in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety profile, including dose-limiting toxicities, maximum tolerated dose, recommended Phase II dose; and the pharmacokinetic profile. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective disease response by modified Response Evaluation Criteria in Solid Tumors. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: August 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-285 Drug: TAK-285 Dose Escalation Cohorts
TAK-285 50 mg tablet, orally, once or twice daily for three weeks, followed by seven days off. Dose escalation to maximum tolerated dose, with possibility of continuous dosing per cycle (daily dosing for four weeks without a break between cycles).
Drug: TAK-285 Recommended Phase 2 Dosing Cohort
Expanded cohort with dose and regimen dependent upon the safety profile of the maximally tolerated dose and schedule determined in the dose escalation phase of the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • The subject has a histologically confirmed advanced non-hematologic malignancy.
  • The subject has a chemotherapy-free interval of at least 4 weeks prior to first dose of study drug.
  • The subject is intolerant of, is not a candidate for, or the subject's disease is refractory to established therapy known to provide clinical benefit for their disease.
  • A female subject of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study, and for 30 days after the last dose of study drug. Male subjects should agree to use contraception for the duration of the study, and for 30 days after the last dose of study drug.
  • The subject has a life expectancy of greater than 12 weeks.
  • The subject has an Eastern Cooperative Oncology Group performance status of 0 to 2.
  • The subject has the ability to swallow and retain oral medication
  • The subject's most recent test values within 2 weeks before the date of entry meet the following standards:

    • Bone marrow function:

      • Absolute neutrophil count ≥1500/mm3
      • Hemoglobin ≥9.0g/dL, platelet count ≥100,000/mm3.
    • Liver function:

      • Total bilirubin ≤1.5 times the upper limit of the standard value of each institution
      • Aspartate aminotransferase and alanine aminotransferase ≤2.5 times the upper limit of the standard value of each institution.
    • Renal function:

      • Serum creatinine ≤1.5 times the upper limit of the standard value of each institution.
  • In the recommended phase 2 dose Cohort, the subject has an accessible tumor for biopsy and is willing to undergo 2 tumor biopsies.
  • In the recommended phase 2 dose Cohort, the subject has at least 1 measurable lesion based on the treatment assessment standards for solid tumors.
  • In the recommended phase 2 dose Cohort, the subject has a tumor that expresses EGFR and/or overexpresses erbB2.

Exclusion Criteria

  • The subject has a symptomatic brain metastasis.
  • The subject has an uncontrollable pleural effusion, ascitic fluid, or pericardial effusion.
  • The subject has active gastrointestinal bleeding as evidenced by either hematemesis or melena.
  • The subject has acute gastrointestinal ulcers.
  • The subject has been treated with a small molecule inhibitor of EGFR or HER2 (except for lapatinib).
  • The subject has a history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years.
  • The subject has significant cardiovascular impairment (history of New York Heart Association class III or IV) or a history of myocardial infarction or unstable angina within the past 6 months prior to study drug treatment.
  • The subject has a severe disease (other than cancer) that will likely affect the prospects of survival or a history that will make it difficult to appropriately manage and follow his or her progress in accordance with the protocol (serious organ disorder, mental illness, drug abuse, alcohol dependency, etc.).
  • The subject requires prohibited treatment (drug, surgery or radiotherapy for treatment of malignant tumor, drugs that could interact with TAK-285) except for radiotherapy of limited area (<20% of total bone marrow) in order to relieve the symptoms from symptomatic bone metastasis.
  • The subject who has been treated with a drug, which inhibits or induces Cytochrome P450 3A4 within 1 week prior to the start of treatment with the investigational drug.
  • The subject is pregnant or breast feeding.
  • The subject has participated in another clinical study/postmarketing clinical study within 4 weeks prior to the start of treatment with TAK-285.
  • The subject is currently taking excluded medications, including:

    • Concurrent anticancer therapy with agents other than TAK-285.
    • The following prohibited medications and substances should not be used for at least 7 days prior to the start of the study and throughout completion:

      • Strong CYP3A4 inhibitors

        • Amiodarone
        • Diltiazem
        • Verapamil
        • Human immunodeficiency virus protease inhibitors
        • itraconazole
        • ketoconazole
        • macrolide antibiotics (excluding azithromycin)
      • Strong CYP3A4 inducers

        • Carbamazepine
        • Efavirenz
        • Nevirapine
        • Phenytoin
        • Rifabutin
        • Rifampin.
        • St. John's wort
      • Medications and devices containing hormones such as oral contraceptives.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535522

Locations
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided by Millennium Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00535522     History of Changes
Other Study ID Numbers: TAK-285_101
Study First Received: September 21, 2007
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:
Pharmacokinetics
pharmacodynamics
maximal tolerated dose

ClinicalTrials.gov processed this record on October 23, 2014