Safety Study of IPI-504 in Patients With Relapsed and Relapsed Refractory Multiple Myeloma

NCT00113204 | Completed Phase 1

• 1 other identifier: IPI-504-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

This is a phase 1 clinical trial to find the safe, maximum tolerated dose of IPI-504 in patients with relapsed and/or relapsed, refractory multiple myeloma. This study will examine how IPI-504 is absorbed, distributed, metabolized, and eliminated by the body. The study will also evaluate potential anti-tumor activity of IPI-504.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; Relapsed; Relapsed refractory; Hematologic cancer; hematologic disease; plasma cells

Outcome Measures

Primary Outcomes (2)

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

  Following 1 cycle of treatment

• Recommend a dose for subsequent studies of IPI-504

  Once MTD is reached

Secondary Outcomes (3)

• To examine the pharmacokinetic parameters of IPI-504

  During first dose first cycle of IPI-504

• To evaluate the potential anti-tumor activity with standard markers of disease progression

  1 cycle of treatment

• To examine pharmacodynamic markers of biologic activity of IPI-504

  Cycle 1 of treatment

Interventions

IPI-504 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 permitted
• 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

Sponsors & Collaborators

• Infinity Pharmaceuticals, Inc.: lead

Study Sites (4)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Hackensack University Medical Center The David Jurist Research Center

Hackensack, New Jersey, 07601, United States

Location

St. Vincent's Comprehensive Cancer Center

New York, New York, 10011, United States

Location

Related Publications (3)

• Maloney A, Workman P. HSP90 as a new therapeutic target for cancer therapy: the story unfolds. Expert Opin Biol Ther. 2002 Jan;2(1):3-24. doi: 10.1517/14712598.2.1.3.

  PMID: 11772336 BACKGROUND

• Pratt WB, Toft DO. Regulation of signaling protein function and trafficking by the hsp90/hsp70-based chaperone machinery. Exp Biol Med (Maywood). 2003 Feb;228(2):111-33. doi: 10.1177/153537020322800201.

  PMID: 12563018 BACKGROUND

• Neckers L. Hsp90 inhibitors as novel cancer chemotherapeutic agents. Trends Mol Med. 2002;8(4 Suppl):S55-61. doi: 10.1016/s1471-4914(02)02316-x.

  PMID: 11927289 BACKGROUND

Related Links

• Click here for more information about Multiple Myeloma

MeSH Terms

Conditions

Multiple Myeloma; Recurrence; Hematologic Neoplasms; Hematologic Diseases

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site

Study Officials

• Sundar Jagannath, MD

  St. Vincent's Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• David S. Siegel, MD; Ph.D

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

• Ivan Borrello, MD

  Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Paul Richardson, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2005
• First Posted: June 7, 2005
• Study Start: June 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

US (4)