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

December 7, 2011 updated by: Millennium Pharmaceuticals, Inc.

A Multicenter, Open-Label, Noncomparative Phase I Clinical and Pharmacokinetic Study of Oral TAK-285 in Patients With Advanced Cancer

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Greenbaum Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety profile, including dose-limiting toxicities, maximum tolerated dose, recommended Phase II dose; and the pharmacokinetic profile.
Time Frame: Duration of study
Duration of study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Objective disease response by modified Response Evaluation Criteria in Solid Tumors.
Time Frame: Duration of study
Duration of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Millennium Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-285_101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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