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A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma


GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety
of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and
is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in
antineoplastic effects.


Inclusion Criteria:



- Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease)

- Relapsed or refractory disease

- At least two prior treatment regimens

- ECOG performance status 0-2

- Adequate hepatic/renal function and platelet count

- If previously treated with an anthracycline, anthracenedione, or trastuzumab, must
have left ventricular ejection fraction > 50%

Exclusion Criteria:

- Prior allogeneic bone marrow transplant, including syngeneic transplant

- Known intracranial disease or epidural disease

- Prior malignancy (within the last 3 years)

- Clinically significant cardiovascular disease or condition

- Active or chronically recurrent bleeding (eg, active peptic ulcer disease

- Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN

- Clinically relevant active infection

- Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or
chronic restrictive pulmonary disease

- Symptomatic hyperviscosity syndrome

- Any other cancer therapy within 3 weeks prior to study, except for mitomycin C,
nitrosoureas, or high-dose chemotherapy with stem cell support within 6 weeks prior
to study

- Investigational therapy within 4 weeks prior to study

- Anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin
prophylaxis therapy and low dose heparin administration for management of IV access
devices

- Radiation therapy within 4 weeks prior to study

- Major surgery within 4 weeks prior to study

- Active autoimmune disease requiring immunosuppressive therapy

- Known positive serology for HIV

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and MTD

Outcome Time Frame:

First 3 weeks

Safety Issue:

Yes

Principal Investigator

Steve Kelsey, MD

Investigator Role:

Study Director

Investigator Affiliation:

Geron Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CP14A004

NCT ID:

NCT00594126

Start Date:

November 2007

Completion Date:

July 2011

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • Relapsed or Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins UniversityBaltimore, Maryland  21231