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Advanced MalignanciesPhase 1NCT00724425

A Phase 1 Dose Escalation Study of IPI-493

A Phase 1 study testing IPI-493 in people with Advanced Malignancies, run by Infinity Pharmaceuticals, Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

IPI-493 is a potent inhibitor of heat shock protein 90 (Hsp90) and is orally bioavailable via a novel formulation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignancies
What is being tested?
IPI-493
Type of treatment
Pill or oral medicine
How many people
53 participants
Where
5 sitesUnited States
Study dates
Jul 2008to Jul 2011
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

  • Patients must have pathologically confirmed advanced solid tumors
  • Progressive disease for their advanced solid tumor
  • Patients must be ≥18 years of age
  • Performance status of 0 or 1.
  • Not Pregnant by blood or urine test, and be willing to use adequate methods of birth control

Who cannot join

  • Treatment with the following therapies within the specified time period:
  • Any chemotherapy (other than nitrosoureas or mitomycin C), radiation therapy (other than whole brain irradiation [WBI]), surgery, hormonal therapy, or investigational therapy within 4 weeks of the start of IPI 493 administration
  • Any tyrosine kinase inhibitor (e.g., erlotinib, imatinib) within 2 weeks
  • Whole brain irradiation therapy within 3 months
  • Stereotactic cranial radiosurgery (SRS) within 4 weeks
  • Nitrosoureas or mitomycin C within 6 weeks
Show all 29Show fewer
  • Any known Hsp90 inhibitor
  • Toxicities from prior therapies must have resolved to ≤ Grade 1 or baseline
  • Concurrent administration of the medications or foods , which are known to inhibit or induce CYP3A activity to a clinically relevant degree, is not allowed.
  • Concurrent treatment with any agent known to prolong the QTc interval
  • Known human immunodeficiency virus (HIV) positivity.
  • Inadequate hematologic function defined by absolute neutrophil count (ANC) < 1,500 cells/mm3, a platelet count < 100,000/mm3, and a hemoglobin < 9.0 g/dL
  • Inadequate hepatic function
  • Inadequate renal function
  • Sinus bradycardia
  • Baseline QTcF > 450 msec in males; QTcF > 470 msec in females.
  • Presence of left bundle branch block (LBBB), right bundle branch block (RBBB) if accompanied by left anterior hemiblock, bifascicular block or 3rd degree heart block. This does not include patients with a history of these events with adequate control by pacemaker.
  • Patients who have received > 450 mg/m2 of any anthracycline during prior chemotherapy must have a baseline left ventricular ejection fraction (LVEF) > 40%.
  • Active keratitis or keratoconjunctivitis.
  • Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
  • Patients with a clinically active brain metastasis
  • Patients with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
  • 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. Examples include, but are not limited to cirrhotic liver disease, sepsis, and other conditions.
  • Women who are pregnant or lactating.
  • Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and meet any of the following criteria are excluded:
  • Have been on a stable dose of anticoagulation for <1 month
  • Have had a Grade 2, 3 or 4 hemorrhage in the past month
  • Are experiencing continued symptoms from their venous thromboembolic event
  • Patients who have had a venous thromboembolic event but do not meet any of the above three criteria are eligible for participation.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Univeristy of Colorado Health Science Center

    Aurora, Colorado, 80045

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75201

  • San Diego Pacific Oncology and Hematology Associates

    Encinitas, California, 92024

  • Premiere Oncology, California

    Santa Monica, California, 90404

  • Premiere Oncology, Arizona

    Scottsdale, Arizona, 85260

Other trials in United States

About this study

Official title: A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of IPI-493 Orally Administered to Patients With Advanced Malignancies

IPI-493 is a potent inhibitor of heat shock protein 90 (Hsp90) and is orally bioavailable via a novel formulation.

Read the detailed description

Hsp90 controls the proper folding, function, and stability of various "client" proteins within cells. Many of the clients of Hsp90 (such as Akt, Bcr-Abl, EGFR, Flt-3, c-Kit and PDGFR α) are oncoproteins or important cell-signaling proteins, and therefore are critical for tumor cell growth and survival. Inhibition of Hsp90 results in degradation of these proteins, which abrogates growth and survival signaling and leads to tumor cell death.

Being tested
IPI-493

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPI-493Drug

    Capsules, Multiple Schedules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the safety and maximum tolerated dose (MTD) of IPI 493

    Measured: ongoing

  2. To recommend a dosing regimen (dose and schedule) for subsequent studies of IPI 493

    Measured: ongoing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJul 2011
  4. Study completionJul 2011

Why it stopped: Drug exposure of retaspimycin HCl was superior to IPI-493, Infinity will focus exclusively on retaspimycin

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00724425
Sponsor's protocol ID
IPI-493-01
Status last verified
Apr 2015
First submitted
25 Jul 2008
Last updated
15 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IPI-493 in people with Advanced Malignancies, run by Infinity Pharmaceuticals, Inc. at 5 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 5 inclusion and 29 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: stopped early, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 was stopped early (reason given: Drug exposure of retaspimycin HCl was superior to IPI-493, Infinity will focus exclusively on retaspimycin). Results are not available in the source record.

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 (MTD) of IPI 493 (time frame: ongoing). 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 NCT00724425.

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 15 Apr 2015.

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