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A Phase 1, Safety Assessment and Pharmacokinetic Study of IPI-504 in Patients With Relapsed, and Relapsed Refractory Multiple Myeloma

Phase 1
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

A Phase 1, Safety Assessment and Pharmacokinetic Study of IPI-504 in Patients With Relapsed, and Relapsed Refractory Multiple Myeloma

IPI-504 is a novel small molecule inhibitor of heat shock protein 90 (Hsp90), an emerging
and recently identified target for cancer therapy. Hsp90 is a protein chaperone that plays a
central role in regulating protein homeostasis. Hsp90 regulates the stability of key
proteins (called "client proteins") and keeps them in the appropriate three dimensional
shape so they can perform their cellular functions. In addition, many of the proteins
stabilized by Hsp90 are oncoproteins and cell-signaling proteins important in cancer cell
proliferation and cancer cell survival. Thus Hsp90, a single molecular target that is a
central integrator of multiple pathways important to cancer, is an ideal novel target for
oncologic therapy. Selective inhibition of Hsp90 will affect multiple downstream mechanisms
to disrupt tumor growth and selectively kill cancer cells. The anti-neoplastic effects of
Hsp90 inhibition have been demonstrated both in vitro and in vivo for a variety of different
hematologic and solid tumors including multiple myeloma.

Inclusion Criteria:

- Diagnosis of relapsed or relapsed, refractory disease

- Age is greater or equal to 18 years at the time of signing the informed consent

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

- Ability to adhere to the study visit schedule and all protocol requirements

- Voluntarily sign an informed consent

- All baseline studies must be completed for determining eligibility within 21 days of
study enrollment

- Women of child-bearing potential (WCBP) defined as a sexually mature woman who has
not undergone a hysterectomy or who has not been naturally post-menopausal for at
least 24 consecutive months must have a negative serum or urine pregnancy test prior
to each cycle of treatment

- All WCBP and all sexually active male patients must agree to use adequate methods of
birth control throughout the study

Exclusion Criteria:

- Disease specific treatment within the previous 3 weeks including use of chemotherapy
that is known to be active or may be active against multiple myeloma

- Previous treatment with 17-AAG, DMAG, or other known Hsp90 inhibitor

- Participation in any investigational drug study within 3 weeks preceding start of
treatment for conventional small molecule therapy or 4 weeks preceding the start of
treatment for biologic or vaccine therapy; concurrent radiation therapy is not

- Concomitant use of corticosteroids may not exceed prednisone 10 mg per day with the
exception of pre-medication for transfusion of blood products and topical application

- Concurrent treatment with any agent that alters CYP3A activity (unless maintained on
stable dose)

- Baseline QTc >450

- NYHA class 3 or 4 congestive heart failure

- Left Bundle Branch Block

- Mycardial infarction or active ischemic heart disease within 6 months

- Grade 3 or greater peripheral neuropathy

- Renal insufficiency, serum creatinine >2x upper limit of normal (ULN)

- Platelets < 30,000 mm3 or refractory to transfusion and unable to be maintained >
50,000 mm3

- AST and / or ALT > 2.0x ULN

- ANC <1,000 cells/mm3

- Hemoglobin < 8.0 g/dL

- Presence of active infection or systemic use of antibiotics within 72 hours of

- WCBP who are breast feeding

- Significant co-morbid condition or disease which in the judgment of the investigator
would place the patient at undue risk or interfere with the study (e.g. cardiac
disease such as acute coronary syndrome or unstable angina within 6 months, New York
Heart Association (NYHA) class 2 or greater congestive heart failure (CHF),
uncontrolled hypertension, arrhythmia requiring medication or mechanical control,
chronic obstructive pulmonary disease (COPD), cirrhotic liver disease, or other

Type of Study:


Study Design:

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

Outcome Measure:

To determine the safety and maximum tolerated dose of IPI-504

Outcome Time Frame:

Following 1 cycle of treatment

Safety Issue:


Principal Investigator

Sundar Jagannath, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Vincent's Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

March 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • Relapsed
  • Relapsed refractory
  • Hematologic cancer
  • hematologic disease
  • plasma cells
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Dana-Farber Cancer Institute Boston, Massachusetts  02115
St. Vincent's Comprehensive Cancer Center New York, New York  10011
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore, Maryland  21231
Hackensack University Medical Center The David Jurist Research Center Hackensack, New Jersey  07601