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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01118689
Other study ID # INK-128-002
Secondary ID
Status Completed
Phase Phase 1
First received May 5, 2010
Last updated July 31, 2013
Start date November 2010
Est. completion date July 2013

Study information

Verified date July 2013
Source Millennium Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of MLN0128 in patients with Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date July 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age =18 years, including males and females;

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;

- Life expectancy of =3 months;

- Does not have diabetes and has normal fasting serum glucose and fasting triglycerides = 300 mg/dL

- For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration;

- Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;

- Ability to swallow oral medications;

- Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures;

Exclusion Criteria:

- Have received prior cancer therapy or other investigational therapy within 2 weeks prior to the first administration of study drug.

- Known impaired cardiac function or clinically significant cardiac disease

- HIV infection;

- Failed to recover from the reversible effects of prior anticancer therapies:

- Pregnancy (positive serum or urine pregnancy test) or breast feeding;

- Malabsorption due to prior gastrointestinal (GI) surgery, GI disease;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
MLN0128
MLN0128 administered orally once daily for 28 days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary determine the dose limiting toxicities 28-days Yes
See also
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