search
Back to results

Safety Study of IPI-504 in Patients With Relapsed and Relapsed Refractory Multiple Myeloma (IPi-504-01)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IPI-504
Sponsored by
Infinity Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, Relapsed, Relapsed refractory, Hematologic cancer, hematologic disease, plasma cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 Presence of active infection or systemic use of antibiotics within 72 hours of treatment 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 conditions)

Sites / Locations

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Dana-Farber Cancer Institute
  • Hackensack University Medical Center The David Jurist Research Center
  • St. Vincent's Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

To determine the safety and maximum tolerated dose of IPI-504
Recommend a dose for subsequent studies of IPI-504

Secondary Outcome Measures

To examine the pharmacokinetic parameters of IPI-504
To evaluate the potential anti-tumor activity with standard markers of disease progression
To examine pharmacodynamic markers of biologic activity of IPI-504

Full Information

First Posted
June 6, 2005
Last Updated
May 15, 2008
Sponsor
Infinity Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00113204
Brief Title
Safety Study of IPI-504 in Patients With Relapsed and Relapsed Refractory Multiple Myeloma
Acronym
IPi-504-01
Official Title
A Phase 1, Safety Assessment and Pharmacokinetic Study of IPI-504 in Patients With Relapsed, and Relapsed Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Infinity Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple myeloma, Relapsed, Relapsed refractory, Hematologic cancer, hematologic disease, plasma cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
IPI-504
Primary Outcome Measure Information:
Title
To determine the safety and maximum tolerated dose of IPI-504
Time Frame
Following 1 cycle of treatment
Title
Recommend a dose for subsequent studies of IPI-504
Time Frame
Once MTD is reached
Secondary Outcome Measure Information:
Title
To examine the pharmacokinetic parameters of IPI-504
Time Frame
During first dose first cycle of IPI-504
Title
To evaluate the potential anti-tumor activity with standard markers of disease progression
Time Frame
1 cycle of treatment
Title
To examine pharmacodynamic markers of biologic activity of IPI-504
Time Frame
Cycle 1 of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 Presence of active infection or systemic use of antibiotics within 72 hours of treatment 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 conditions)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sundar Jagannath, MD
Organizational Affiliation
St. Vincent's Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David S. Siegel, MD; Ph.D
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ivan Borrello, MD
Organizational Affiliation
Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Richardson, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Hackensack University Medical Center The David Jurist Research Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11772336
Citation
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.
Results Reference
background
PubMed Identifier
12563018
Citation
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.
Results Reference
background
PubMed Identifier
11927289
Citation
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.
Results Reference
background
Links:
URL
http://www.multiplemyeloma.org/
Description
Click here for more information about Multiple Myeloma

Learn more about this trial

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

We'll reach out to this number within 24 hrs