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Solid TumorsPhase 1NCT00606814

Phase I Study of IPI-504 and Docetaxel in Patients With Advanced Solid Tumors

A Phase 1 study testing IPI-504, docetaxel in people with Solid Tumors, run by Infinity Pharmaceuticals, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a Phase I clinical trial of IPI-504 in combination with docetaxel (Taxotere).The purposes of the study are to determine: the safety profile, the highest dose of IPI-504 that can be given with docetaxel without causing severe side effects, and to recommend a Phase II dose of the combination in patients… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
IPI-504, docetaxel
Type of treatment
Injection or infusion
How many people
60 participants
Where
8 sitesUnited States
Study dates
Dec 2007to Dec 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

  • Pathologically confirmed malignancy that is metastatic or unresectable, for which one of the two statements must apply:
  • Standard therapy able to provide clinical benefit does not exist or is no longer effective AND / OR
  • Single agent docetaxel would be appropriate therapy.
  • Progressive disease with development of new lesions or an increase in preexisting lesions on CT, MRI, PET, bone scintigraphy, or by physical examination.
  • Measurable disease by RECIST criteria with the exception of prostate cancer patients.
  • >18 years of age at the time of signing the Informed Consent Form (ICF) and have a life expectancy of at least 3 months.
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  • Karnofsky performance status of 70 or better.
  • Adhere to the study visit schedule
  • Voluntarily sign the Informed Consent Form (ICF).
  • Baseline studies completed within 30 days of first study dose.
  • 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 within 2 weeks of first study dose and prior to each additional cycle of treatment.
  • All WCBP and all sexually active male patients must agree to use adequate methods of birth control throughout the study
  • Non-small cell lung cancer (NSCLC)enrolled in the Expansion Phase of the study must meet the following additional inclusion criteria:
  • NSCLC that meets the disease criteria described in the first three Inclusion Criteria.
  • Must have archival NSCLC tissue available for submission and analysis.

Who cannot join

  • Treatment within 1 week of the start of IPI-504 for erlotinib, and imatinib; within 2 weeks for gefitinib, and any other tyrosine kinase inhibitor (approved or investigational); within 4 weeks for any biologic therapy (antibody, vaccine, or other protein-based therapy), radiation therapy, or conventional chemotherapy; within 6 weeks for nitrosoureas or mitomycin C.
  • Radiation therapy within 2 weeks of the start of IPI-504. (Patients must have recovered from any toxicities.)
  • Concurrent radiation therapy or treatment with any other investigational agent is not permitted.
  • Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to Cycle 1, Dose 1.
  • Symptomatic peripheral neuropathy ≥ Grade 2.
  • 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 (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
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  • Inadequate renal function defined by AST and/or ALT >1.5; total bilirubin above the upper limit of normal.
  • Inadequate renal function defined by serum creatinine >1.5 x ULN.
  • Sinus bradycardia (resting heart rate <50) secondary to intrinsic conduction system disease. Patients with sinus bradycardia secondary to pharmacologic treatment may enroll if withdrawal of the treatment results in normalization of the resting heart rate to within normal limits.
  • Baseline QTc >450 msec in males; QTc >470 msec in females, or previous history of QT prolongation while taking other medications.
  • Presence of left bundle branch block, right bundle branch block plus left anterior hemiblock, bifasicular 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 LVEF >40%.
  • Active keratitis or keratoconjunctivitis.
  • History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  • Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
  • Untreated brain metastases. Note: Patients with a history of brain metastases are eligible as long as definitive treatment has been given and patients are clinically stable.
  • 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, uncontrolled hypertension, arrhythmia requiring medication or mechanical control, cirrhotic liver disease, or other conditions).
  • Previous or current malignancies at other sites within the last 2 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
  • HIV-positive patients receiving combination antiretroviral therapy.
  • Women who are pregnant or lactating.
  • Previous treatment with 17-AAG, DMAG, or other known Hsp90 inhibitor.
  • Patients with prior hepatic resection or hepatic-directed therapy (e.g., chemoembolization or Theresphere).
  • Patients with non-small cell lung cancer (NSCLC)enrolled in the Expansion Phase of the study must meet the following additional exclusion criteria:
  • Prior treatment with docetaxel
  • Three or more chemotherapy regimens for metastatic disease. Note: Any number of prior treatment regimens with tyrosine kinase inhibitors is permitted.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Gabrail Cancer Center

    Dover, Ohio, 44622

  • Yale Cancer Center

    New Haven, Connecticut, 06519

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10066

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • TGen Clinical Research in Scottsdale

    Scottsdale, Arizona, 85258

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase I Study of IPI-504 and Docetaxel in Patients With Advanced Solid Tumors

This study is a Phase I clinical trial of IPI-504 in combination with docetaxel (Taxotere).The purposes of the study are to determine:

  • the safety profile,
  • the highest dose of IPI-504 that can be given with docetaxel without causing severe side effects, and
  • to recommend a Phase II dose of the combination in patients with solid tumors.
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 is a multi-center, open-label, dose escalating study in which patients will be treated with a fixed dose of docetaxel followed by IPI-504 following one of three dosing schedules.

Once an MTD has been defined, up to 20 additional patients with non-small cell lung cancer (NSCLC) will be enrolled.

Conditions
Solid Tumors
Being tested
IPI-504, docetaxel
Keywords
Solid Tumors, IPI-504, docetaxel,cancer
Medical subject headings
Neoplasms

What participants receive

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

  • IPI-504, docetaxelDrug

    Also called Taxotere

    1. IPI-504 administered IV at a dose of 300mg/m2
    2. Docetaxel at a fixed dose of 75 mg/m2 for every 3 weeks dose administration or 36 mg/m2 for weekly administration

What is being measured

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

  1. To determine the safety, maximum tolerated dose(MTD)of IPI-504 in combination with docetaxel in patients with advanced solid tumors and recommend the Phase II dose of the combination of drugs.

    Measured: Weekly

Secondary outcomes (2)

  1. To determine the pharmacokinetics (PK) and response rate (CR+PR) for patients with measurable lesions (as determine by RECIST)

    Measured: Weekly

  2. To determine the pharmacokinetics (PK) of IPI-504 and docetaxel

    Measured: Weekly

Timeline

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

  1. First posted5 Feb 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionMay 2011
  4. Study completionDec 2011

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00606814
Sponsor's protocol ID
IPI-504-05
Other IDs
IPI-504-05
Status last verified
Mar 2012
First submitted
22 Jan 2008
Last updated
6 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IPI-504, docetaxel in people with Solid Tumors, run by Infinity Pharmaceuticals, Inc. at 8 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 15 inclusion and 25 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 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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, maximum tolerated dose(MTD)of IPI-504 in combination with docetaxel in patients with advanced solid tumors and recommend the Phase II dose of the combination of drugs. (time frame: Weekly). 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 NCT00606814.

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 6 Mar 2012.

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