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A Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent MLN0128 in Subjects With Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Waldenstrom Macroglobulinemia

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Trial Information

A Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent MLN0128 in Subjects With Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia


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;

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

determine the dose limiting toxicities

Outcome Time Frame:

28-days

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:

INK-128-002

NCT ID:

NCT01118689

Start Date:

November 2010

Completion Date:

January 2014

Related Keywords:

  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Waldenström Macroglobulinemia
  • Waldenstrom Macroglobulinemia
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Fountain Valley, California  92708
Columbia, Missouri  65203
Nashville, Tennessee  37203-1632
Hackensack, New Jersey  07601
Denver, Colorado  
Boston, Massachusetts