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    Summary
    EudraCT Number:2008-002396-28
    Sponsor's Protocol Code Number:IPI-504-06
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-04-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2008-002396-28
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of IPI-504 in Patients with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors Following Failure of at Least Imatinib and Sunitinib
    A.4.1Sponsor's protocol code numberIPI-504-06
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInfinity Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/512
    D.3 Description of the IMP
    D.3.1Product nameRetaspimycin hydrochloride
    D.3.2Product code IPI-504
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRetaspimycin hydrochloride
    D.3.9.2Current sponsor codeIPI-504
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic and/or unresectable gastro-intestinal stromal tumors in patients following failure of treatment with at least imatinib and sunitinib.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10062427
    E.1.2Term Gastrointestinal stromal tumor
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the progression free survival (PFS) following administration of IPI-504 plus best supportive care versus placebo plus best supportive care in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) following failure of at least imatinib and sunitinib.
    E.2.2Secondary objectives of the trial
    1. Compare the disease control rate (DCR) in both arms of the study.
    2. Compare the time to progression (TTP) in both arms of the study.
    3. Compare the overall survival (OS) in both arms of the study.
    4. Evaluate the safety and tolerability of IPI-504 in this patient population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following:
    1. At least 18 years of age at the time of study randomization.
    2. Histologically confirmed metastatic and/or unresectable GIST.
    3. Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST with at least one measurable lesion.
    4. Documented radiographic progression or intolerance to imatinib and sunitinib.
    5. Clinical failure of the most recent prior therapy for GIST. Note: There is no limit to the number of prior therapies a patient may have received (e.g., patients may have received treatment with nilotinib, other TKIs, or chemotherapy in addition to imatinib or sunitinib).
    6. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
    7. Administration of the last dose of imatinib or nilotinib ≥1 week, any other TKI ≥ 2 weeks, chemotherapy, radiotherapy, surgery, ablative therapy, biologic therapy (e.g., antibodies, vaccines), or any other investigational therapies ≥ 4 weeks prior to randomization.
    8. Resolution of all toxic effects of imatinib, sunitinib, other TKIs, surgery, radiotherapy, chemotherapy, lesion ablative therapy, or investigational therapy to baseline or Grade 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.
    9. Patients must have normal organ and marrow function as defined below:
    •Hemoglobin ≥ 8.0 g/dL (80 g/L).
    •Absolute Neutrophil Count ≥ 1500/μL (1.5 x 10^9/L).
    •Platelets ≥ 100,000 /μL (100 x 10^9/L).
    •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), or ≤ 3.0 x ULN if considered secondary to liver metastases.
    •Alkaline phosphatase ≤ 2.5 x ULN, or ≤ 3.0 x ULN if considered secondary to liver metastases.
    •Serum bilirubin ≤ 1.5 x ULN.
    •Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5 x ULN unless the patient is receiving warfarin. If the patient is receiving warfarin, the international normalized ratio (INR) must be within therapeutic range.
    •Serum creatinine ≤ 1.5 x ULN.
    •Albumin ≥ 3.0 g/dL.
    10.Women of reproductive potential (defined as being less than 1 year post-menopausal) must have a negative serum or urine β human chorionic gonadotropin (βHCG) pregnancy test; and men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy while receiving study drug and for 30 days after the final dose of study drug. Effective contraception includes use of oral contraceptives with an additional barrier method, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, and total abstinence.
    11.Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures.
    E.4Principal exclusion criteria
    Patients must have none of the following:
    1. Previous administration of 17-allylamino-17-demethoxygeldanamycin (17-AAG), 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), or other known heat shock protein 90 (Hsp90) inhibitors.
    2. Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease.
    3. Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to
    administration of IPI-504 or placebo. A list of clinically relevant CYP3A inhibitors and inducers is found in
    Appendix 2. Patients who are on a stable dose of a drug that is not listed in Appendix 2 but is known to alter
    CYP3A activity for > 2 weeks are eligible to enroll.
    4. Patients with a history of any of the following within the last 6 months: cardiac disease such as acute coronary syndrome or unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, cirrhotic liver disease, cerebrovascular accident, or any other 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., psychiatric or other conditions).
    5. Grade 3 or 4 hemorrhagic event within the last 6 months.
    6. Known human immunodeficiency virus positivity.
    7. Sinus bradycardia (resting heart rate < 50 bpm) secondary to intrinsic conduction system disease. Patients with sinus bradycardia secondary to pharmacologic therapy may enroll if discontinuation of the therapy results in normalization of the resting heart rate to within normal limits.
    8. Baseline QT corrected using Fridericia’s correction method (QTcF) ≥ 470 milliseconds (msec), or previous history of clinically significant QTc prolongation while taking other medications.
    9. History of prior malignancies within the past 3 years other than non-melanomatous skin cancers that have been controlled, prostate cancer that has been treated and has not recurred, non-muscle-invasive bladder cancer, and carcinoma in situ of the cervix.
    10. Active or recent history (within 3 months) of keratitis or keratoconjunctivitis confirmed by ophthalmology or optometry exam.
    11. Presence of Left Bundle Branch Block, Right Bundle Branch Block plus 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.
    12. Patients with known central nervous system (CNS) metastases. Patients with symptoms indicative of CNS metastases must have a head CT or brain MRI at screening.
    13. Women who are pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    The primary assessment of antitumor activity is progression free survival (PFS). PFS is defined as the time from randomization to the first documentation of disease progression or death due to any cause, whichever occurs first. Disease progression is defined as radiographic progression by Response Evaluation Criteria in Solid Tumors (RECIST).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    3 years after randomisation of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-04-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 195
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-04-15
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