AzTrials
AzTrials

CancerPhase 1NCT00535522

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

A Phase 1 study testing TAK-285 Dose Escalation Cohorts and TAK-285 Recommended Phase 2 Dosing Cohort in people with Cancer, run by Millennium Pharmaceuticals, Inc. at 3 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
TAK-285 Dose Escalation Cohorts and TAK-285 Recommended Phase 2 Dosing Cohort
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
3 sitesUnited States
Study dates
Aug 2007to Jun 2011
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

  • 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.
Show all 19Show fewer
  • 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.

Who cannot join

  • 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.
Show all 32Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Maryland Greenbaum Cancer Center

    Baltimore, Maryland, 21201

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: 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.

Conditions
Cancer
Being tested
TAK-285 Dose Escalation Cohorts, TAK-285 Recommended Phase 2 Dosing Cohort
Keywords
Pharmacokinetics, pharmacodynamics, maximal tolerated dose
Medical subject headings
Neoplasms

What participants receive

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

  • TAK-285 Dose Escalation CohortsDrug

    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).

  • TAK-285 Recommended Phase 2 Dosing CohortDrug

    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.

Study groups in NCT00535522
Study groupRoleWhat they receive
TAK-285ExperimentalNot described
Receives: Drug: TAK-285 Dose Escalation Cohorts; Drug: TAK-285 Recommended Phase 2 Dosing Cohort

What is being measured

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

  1. Safety profile, including dose-limiting toxicities, maximum tolerated dose, recommended Phase II dose; and the pharmacokinetic profile.

    Measured: Duration of study

Secondary outcomes (1)

  1. Objective disease response by modified Response Evaluation Criteria in Solid Tumors.

    Measured: Duration of study

Timeline

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

  1. First posted26 Sep 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionJun 2011
  4. Study completionJun 2011

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00535522
Sponsor's protocol ID
TAK-285_101
Status last verified
Dec 2011
First submitted
21 Sep 2007
Last updated
9 Dec 2011
Results posted
No
Data monitoring committee
No

Publications

  • LoRusso P, Venkatakrishnan K, Chiorean EG, Noe D, Wu JT, Sankoh S, Corvez M, Sausville EA. Phase 1 dose-escalation, pharmacokinetic, and cerebrospinal fluid distribution study of TAK-285, an investigational inhibitor of EGFR and HER2. Invest New Drugs. 2014 Feb;32(1):160-70. doi: 10.1007/s10637-013-9988-x. Epub 2013 Jul 2.

    PubMed 23817974

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-285 Dose Escalation Cohorts and TAK-285 Recommended Phase 2 Dosing Cohort in people with Cancer, run by Millennium Pharmaceuticals, Inc. 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 19 inclusion and 32 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 9 Dec 2011. 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?

Safety profile, including dose-limiting toxicities, maximum tolerated dose, recommended Phase II dose; and the pharmacokinetic profile. (time frame: Duration of study). 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 NCT00535522, which also lists 1 linked publication.

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 9 Dec 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in