Lung CancerPhase 1/2NCT00431015
Phase I/II Safety Study of IPI-504 in Relapsed/Refractory Stage IIIb, or Stage IV Non-small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing IPI-504 in people with Lung Cancer, run by Infinity Pharmaceuticals, Inc. at 11 sites in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of IPI-504 in patients with non-small cell lung cancer (NSCLC). The 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
- Lung Cancer
- What is being tested?
- IPI-504
- Type of treatment
- Injection or infusion
- How many people
- 88 participants
- Where
- 11 sitesUnited States
- Study dates
- Jan 2007to Dec 2011
- Phase
- Phase 1/2
- 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
- Pathologically confirmed diagnosis of a Stage IIIb (with malignant pleural or pericardial effusion) or Stage IV NSCLC
- Measurable disease by RECIST criteria.
Who cannot join
- Treatment for NSCLC with any approved or investigational product within 2 weeks of the start of IPI-504 treatment for any small molecule therapy; within 4 weeks of the start of IPI-504 treatment for any biologic or any conventional chemotherapy.
- Inadequate hematologic or renal or hepatic function
- Previous treatment with 17-AAG, DMAG or other known Hsp90 inhibitor.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Medical College of Georgia
Augusta, Georgia, 30912
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Mary Crowley Cancer Research Centers - Medical City
Dallas, Texas, 75201
Mary Crowley Cancer Research Centers - Baylor
Dallas, Texas, 75246
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06519
Seattle Cancer Care Alliance
Seattle, Washington, 98109
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase I/II Study to Investigate the Safety, Tolerability and Potential Activity of IPI-504 in Relapsed and / or Refractory Stage IIIb (With Malignant Pleural or Pericardial Effusion), or Stage IV NSCLC Patients
The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of IPI-504 in patients with non-small cell lung cancer (NSCLC). The study will examine how IPI-504 is absorbed, distributed, metabolized and eliminated by the body. The study will also evaluate the 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 maintaining the proper folding, function and viability of various "client proteins". Many of the client proteins stabilized by Hsp90 are oncoproteins and cell-signaling proteins important in cancer cell proliferation and cancer cell survival. This clinical trial will study the effects of IPI-504 in a molecularly defined sub-group of patients who carry client proteins found in non-small cell lung cancer.
- Conditions
- Lung Cancer
- Being tested
- IPI-504
- Keywords
- Lung Cancer, Cancer of the lung, Non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-504Drug
IV Hsp90 inhibitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria
Measured: Every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infinity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lecia Sequist, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431015
- Sponsor's protocol ID
- IPI-504-03
- Status last verified
- Dec 2012
- First submitted
- 31 Jan 2007
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Investigate the Safety, Tolerability and Potential Activity of IPI-504 in Relapsed and / or Refractory Stage IIIb (With Malignant Pleural or Pericardial Effusion), or Stage IV NSCLC Patients
- ClinicalTrials.gov ID
- NCT00431015
- Acronym / sponsor ID
- IPI-504-03
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Cancer of the lung, Non-small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Infinity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Feb 2007 (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.
The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of IPI-504 in patients with non-small cell lung cancer (NSCLC). The study will examine how IPI-504 is absorbed, distributed, metabolized and eliminated by the body. The study will also evaluate the 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 maintaining the proper folding, function and viability of various "client proteins". Many of the client proteins stabilized by Hsp90 are oncoproteins and cell-signaling proteins important in cancer cell proliferation and cancer cell survival. This clinical trial will study the effects of IPI-504 in a molecularly defined sub-group of patients who carry client proteins found in non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (2 listed)
- Pathologically confirmed diagnosis of a Stage IIIb (with malignant pleural or pericardial effusion) or Stage IV NSCLC
- Measurable disease by RECIST criteria.
Key exclusion criteria (3 listed)
- Treatment for NSCLC with any approved or investigational product within 2 weeks of the start of IPI-504 treatment for any small molecule therapy; within 4 weeks of the start of IPI-504 treatment for any biologic or any conventional chemotherapy.
- Inadequate hematologic or renal or hepatic function
- Previous treatment with 17-AAG, DMAG or other known Hsp90 inhibitor.
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-504IV Hsp90 inhibitor | Drug | – |
Primary outcome
Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria
Time frame: Every 6 weeks
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 10 Dec 2012.
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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.
Lecia Sequist, MD principal investigator
Massachusetts General Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPI-504 in people with Lung Cancer, run by Infinity Pharmaceuticals, Inc. at 11 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 2 inclusion and 3 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 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria (time frame: Every 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2012; AzTrials last refreshed its copy on 7 Nov 2026.