NeoplasmsPhase 1NCT00761696
A Phase 1 Study of IPI-926 in Patients With Advanced and/or Metastatic Solid Tumor Malignancies
A Phase 1 study testing IPI-926 in people with Neoplasms, run by Infinity Pharmaceuticals, Inc. at 5 sites in 2 countries.
Trial summary
The primary objectives of the study are: To determine the safety and the maximum tolerated dose (MTD) of IPI-926 To examine the pharmacokinetic parameters of IPI-926 and its characterized major metabolite(s) To recommend a dose and schedule of IPI-926 for subsequent studies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- IPI-926
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2008to Apr 2012
- 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
- Pathologically confirmed diagnosis of a solid tumor for which no standard therapy proven to provide clinical benefit is available.
- ≥18 years of age
- Life expectancy of at least 3 months.
- ECOG performance status of 0 to 2.
- Ability to follow the study and all protocol requirements.
- Voluntarily sign an informed consent form
- Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation of who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum or urine pregnancy test prior to treatment. All WCBP, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study.
- Recovery to </= Grade 1 or baseline of any toxicities due to prior treatments, excluding alopecia.
Who cannot join
- Treatment with following therapies as indicated:
- Any chemotherapy (other than nitrosoureas or mitomycin C), radiation therapy, surgery, hormonal therapy, or investigational therapy within 4 weeks of the start of IPI-926 administration. Patients with luteinizing hormone releasing hormone therapy.
- Any tyrosine kinase inhibitor (e.g. erlotinib, imatinib) within 2 weeks of the start of IPI-926 administration
- Nitrosoureas o or mitomycin C within 6 weeks of the start of IPI-926 administration.
- Inadequate hematologic function - neutrophil count (ANC) <1,500 cells/mm3, platelet count <100,000/mm3, or hemoglobin <9.0 g/dL (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
- Inadequate hepatic function - aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN); >5 x ULN if attributable to liver metastases; total bilirubin >1.5 x ULN.
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- Inadequate renal function - serum creatinine >1.5 x ULN.
- Uncontrolled hypomagnesemia or hypokalemia, defined as ≥ Grade 3 despite adequate electrolyte supplementation.
- Baseline QTcF >450 msec in men or >470 msec in women.
- Concurrent treatment with any agent known to prolong the QTc interval.
- Prior surgery affecting drug absorption or any gastrointestinal dysfunction that could alter drug absorption (e.g. gastric bypass, Whipple procedure, gastrectomy).
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
- Venous thromboembolic event (e.g. pulmonary embolism or deep vein thrombosis) requiring anticoagulation or who 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 last 30 days
- experiencing continued symptoms from venous thromboembolic event (e.g. continued dyspnea or oxygen requirement) *Past venous thromboembolic event but do not meet any of the above three criteria are eligible for participation.
- History of a seizure within the last 10 years or seizure disorder requiring anti-epileptic medications.
- Concurrent treatment with medications known to lower the seizure threshold.
- Concurrent administration of the medications or foods which are known to inhibit or induce CYP3A activity to a clinically relevant degree.
- Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
- 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.
- Known immunodeficiency virus (HIV) positivity.
- Pregnant or lactating women.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Colorado Health Science Center
Aurora, Colorado, 80045
Johns Hopkins Uninversity
Baltimore, Maryland, 21231
Stanford University
Redwood City, California, 94063
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, 85258
Canada1 site
McGill University Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
The primary objectives of the study are:
- To determine the safety and the maximum tolerated dose (MTD) of IPI-926
- To examine the pharmacokinetic parameters of IPI-926 and its characterized major metabolite(s)
- To recommend a dose and schedule of IPI-926 for subsequent studies
Read the detailed description
Study IPI-926-01 is a Phase 1, open-label, dose-escalation study in patients with advanced and/or metastatic solid tumor malignancies.
- Conditions
- Neoplasms
- Being tested
- IPI-926
- Keywords
- solid tumor malignancies
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-926Drug
Also called Hedgehog pathway inhibitor
Oral daily dosing
| Study group | Role | What they receive |
|---|---|---|
| IPI-926 | Experimental | Oral daily dosing Receives: Drug: IPI-926 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and the maximum tolerated dose (MTD) of IPI-926
Measured: 6mths to 1 year
Secondary outcomes (1)
To evaluate the anti-tumor activity of IPI-926
Measured: 6mths to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infinity Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Ross, MD, Study director, Infinity Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761696
- Sponsor's protocol ID
- IPI-926-01
- Status last verified
- Jun 2012
- First submitted
- 25 Sep 2008
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of IPI-926 in Patients With Advanced and/or Metastatic Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT00761696
- Acronym / sponsor ID
- IPI-926-01
- Conditions
- Neoplasms
- Keywords
- solid tumor malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Infinity Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 29 Sep 2008 (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 primary objectives of the study are:
- To determine the safety and the maximum tolerated dose (MTD) of IPI-926
- To examine the pharmacokinetic parameters of IPI-926 and its characterized major metabolite(s)
- To recommend a dose and schedule of IPI-926 for subsequent studies
Detailed description
Study IPI-926-01 is a Phase 1, open-label, dose-escalation study in patients with advanced and/or metastatic solid tumor malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPI-926 | Experimental | Drug: IPI-926Oral daily dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically confirmed diagnosis of a solid tumor for which no standard therapy proven to provide clinical benefit is available.
- ≥18 years of age
- Life expectancy of at least 3 months.
- ECOG performance status of 0 to 2.
- Ability to follow the study and all protocol requirements.
Key exclusion criteria (23 listed)
- Treatment with following therapies as indicated:
- Inadequate hematologic function - neutrophil count (ANC) <1,500 cells/mm3, platelet count <100,000/mm3, or hemoglobin <9.0 g/dL (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
- Inadequate hepatic function - aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN); >5 x ULN if attributable to liver metastases; total bilirubin >1.5 x ULN.
- Inadequate renal function - serum creatinine >1.5 x ULN.
- Uncontrolled hypomagnesemia or hypokalemia, defined as ≥ Grade 3 despite adequate electrolyte supplementation.
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-926Also: Hedgehog pathway inhibitorOral daily dosing | Drug | IPI-926 |
Primary outcome
To determine the safety and the maximum tolerated dose (MTD) of IPI-926
Time frame: 6mths to 1 year
1 secondary outcome
To evaluate the anti-tumor activity of IPI-926
Time frame: 6mths to 1 year
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 21 Jun 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.
Robert Ross, MD study director
Infinity Pharmaceuticals, Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPI-926 in people with Neoplasms, run by Infinity Pharmaceuticals, Inc. at 5 sites in 2 countries.
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 23 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 21 Jun 2012. 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, Canada. 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 the maximum tolerated dose (MTD) of IPI-926 (time frame: 6mths to 1 year). 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 21 Jun 2012.