Multiple MyelomaPhase 1IPi-504-01NCT00113204
Safety Study of IPI-504 in Patients With Relapsed and Relapsed Refractory Multiple Myeloma
A Phase 1 study testing IPI-504 in people with Multiple Myeloma, run by Infinity Pharmaceuticals, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- IPI-504
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2005to Mar 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Hackensack University Medical Center The David Jurist Research Center
Hackensack, New Jersey, 07601
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
About this study
Official title: A Phase 1, Safety Assessment and Pharmacokinetic Study of IPI-504 in Patients With Relapsed, and Relapsed Refractory Multiple Myeloma
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- IPI-504
- Keywords
- Multiple myeloma, Relapsed, Relapsed refractory, Hematologic cancer, hematologic disease, plasma cells
- Medical subject headings
- Multiple Myeloma, Recurrence, Hematologic Neoplasms, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-504Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and maximum tolerated dose of IPI-504
Measured: Following 1 cycle of treatment
Recommend a dose for subsequent studies of IPI-504
Measured: Once MTD is reached
Secondary outcomes (3)
To examine the pharmacokinetic parameters of IPI-504
Measured: During first dose first cycle of IPI-504
To evaluate the potential anti-tumor activity with standard markers of disease progression
Measured: 1 cycle of treatment
To examine pharmacodynamic markers of biologic activity of IPI-504
Measured: Cycle 1 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2005 (estimated)
- Study startJun 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infinity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sundar Jagannath, MD, Principal investigator, St. Vincent's Comprehensive Cancer CenterDavid S. Siegel, MD; Ph.D, Principal investigator, Hackensack Meridian HealthIvan Borrello, MD, Principal investigator, Johns Hopkins - Sidney Kimmel Comprehensive Cancer CenterPaul Richardson, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113204
- Sponsor's protocol ID
- IPI-504-01
- Acronym
- IPi-504-01
- Status last verified
- May 2008
- First submitted
- 6 Jun 2005
- Last updated
- 20 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11772336Pratt 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.
PubMed 12563018Neckers 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.
PubMed 11927289
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Safety Assessment and Pharmacokinetic Study of IPI-504 in Patients With Relapsed, and Relapsed Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00113204
- Acronym / sponsor ID
- IPi-504-01 / IPI-504-01
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Relapsed, Relapsed refractory, Hematologic cancer, hematologic disease, plasma cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Infinity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 7 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPI-504 | Drug | – |
Primary outcome
To determine the safety and maximum tolerated dose of IPI-504
Time frame: Following 1 cycle of treatment
Recommend a dose for subsequent studies of IPI-504
Time frame: Once MTD is reached
3 secondary outcomes
To examine the pharmacokinetic parameters of IPI-504
Time frame: During first dose first cycle of IPI-504
To evaluate the potential anti-tumor activity with standard markers of disease progression
Time frame: 1 cycle of treatment
To examine pharmacodynamic markers of biologic activity of IPI-504
Time frame: Cycle 1 of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2008.
- Background: PubMed 11772336Maloney 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.
- Background: PubMed 12563018Pratt 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.
- Background: PubMed 11927289Neckers 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.
- Click here for more information about Multiple MyelomaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sundar Jagannath, MD principal investigator
St. Vincent's Comprehensive Cancer Center
David S. Siegel, MD; Ph.D principal investigator
Hackensack Meridian Health
Ivan Borrello, MD principal investigator
Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPI-504 in people with Multiple Myeloma, run by Infinity Pharmaceuticals, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety and maximum tolerated dose of IPI-504 (time frame: Following 1 cycle of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00113204, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2008.