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An Open-Label, Dose Escalation, Phase I Study of TAK-901 in Adult Patients With Advanced Solid Tumors or Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Lymphoma

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Trial Information

An Open-Label, Dose Escalation, Phase I Study of TAK-901 in Adult Patients With Advanced Solid Tumors or Lymphoma


Inclusion Criteria:



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

- ECOG performance status of < or equal to 2.

- Diagnosis of solid tumor malignancy or lymphoma for which standard treatment is no
longer effective.

- Have a radiographically or clinically evaluable tumor or lymphoma.

- Measurable disease as described in the protocol.

- Suitable venous access for the study-required blood sampling.

- Female patients who are post menopausal, surgically sterile, or agree to practice 2
effective methods of contraception or abstain from heterosexual intercourse.

- Male patients who agree to practice effective barrier contraception or agree to
abstain from heterosexual intercourse.

- Voluntary written consent.

- Weigh at least 45 kg.

- Recovered from the reversible effects of prior antineoplastic therapy.

- Meet clinical laboratory values during the screening period as specified in the
protocol.

- Left ventricular ejection fraction (LVEF) > or equal to 50% by echocardiogram or
multiple acquisition scan (MUGA).

Exclusion Criteria:

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

- Diagnosis of primary CNS malignancy or carcinomatous meningitis.

- Patient has symptomatic brain metastasis.

- Prior bone allogeneic bone marrow or stem cell transplant.

- Prior radiotherapy involving > or equal to 30% of the hematopoietically active bone
marrow, within 21 days before the start of the study drug.

- Systemic antineoplastic therapy within 28 days before the start of the study drug,
except for luteinizing hormone-releasing-hormone (LHRH) agonist therapy.

- Exposure to nitrosureas or mitomycin C within 42 days before the start of the study
drug.

- Treatment with monoclonal antibodies within 28 days before the start of the study
drug.

- Known allergy or hypersensitivity to compounds of similar chemical composition to
TAK-901 or its excipient, Captisol.

- Female patients who are lactating or who have a positive serum pregnancy test during
the screening period or a positive serum pregnancy test during the screening period.

- Myocardial infarction within 6 months before enrollment.

- Evidence of current uncontrolled cardiovascular conditions, including cardiac
arrhythmias, congestive heart failure, angina, or electrocardiographic evidence of
acute ischemia or active conduction system abnormalities.

- Abnormalities on 12-lead electrocardiogram (ECG) as specified in the protocol.

- Infection requiring systemic anti-infective therapy within 14 days before the start
of study drug.

- Known human immunodeficiency virus (HIV)positive, hepatitis B surface
antigen-positive status, or known or suspected active hepatitis C infection.

- Diagnosed or treated for another malignancy within 2 years before the start of study
drug or previously diagnosed with another malignancy and have any evidence of
residual disease.

- Any serious medical or psychiatric illness that could, in the investigator's opinion,
potentially interfere with the completion of treatment.

- Treatment with any investigational products within 28 days before the first dose of
study drug.

- Systemic use of strong CYP3A inhibitors or inducers (as specified in the protocol)
within 14 days before the first dose of study drug.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C19001

NCT ID:

NCT00935844

Start Date:

October 2009

Completion Date:

November 2011

Related Keywords:

  • Advanced Solid Tumors
  • Lymphoma
  • Advanced solid tumors
  • Lymphoma
  • Lymphoma
  • Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Karmanos Cancer CenterDetroit, Michigan  48201
The University of MichiganAnn Arbor, Michigan  48109