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    Summary
    EudraCT Number:2012-000558-71
    Sponsor's Protocol Code Number:9090-11
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-000558-71
    A.3Full title of the trial
    An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women with Breast Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the study drug Ganetespib (STA-9090) for women who have breast cancer
    A.4.1Sponsor's protocol code number9090-11
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSynta Pharmaceuticals Corp.
    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 supportSynta Pharmaceuticals Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynta Pharmaceuticals Corp.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address45 Hartwell Avenue
    B.5.3.2Town/ cityLexington, MA
    B.5.3.3Post code02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number001781541-7170
    B.5.5Fax number001781541-7103
    B.5.6E-mailIELhariry@syntapharma.com
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGanetespib
    D.3.2Product code STA-9090
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNganetespib
    D.3.9.1CAS number 888216-25-9
    D.3.9.2Current sponsor codeSTA-9090
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Paclitaxel concentrate for solution
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePaclitaxel
    D.3.2Product code ATC code: L01C D01
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HER2 positive, triple negative breast cancer (TNBC) and hormone-receptor (ER/PR)-positive breast cancer.
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10065430
    E.1.2Term HER-2 positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10054057
    E.1.2Term Progesterone receptor assay positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the objective response rate of ganetespib monotherapy in patients with these subtypes of breast cancer: HER2+, TNBC, and hormone-receptor (ER/PR)-positive disease.
    E.2.2Secondary objectives of the trial
    Evaluate the change in F-18 fluorodeoxyglucose (FDG) tumor uptake as a predictor of clinical response following one cycle of treatment with ganetespib monotherapy; Evaluate the clinical benefit rate (CBR), duration of response (DOR), and PFS with ganetespib monotherapy; Determine the qualitative and quantitative toxicities associated with ganetespib monotherapy; Evaluate the relationship of clinical outcome with relevant biomarkers and, genetic changes, and proteome and transcriptome profiles present in tumor tissues and serum and plasma samples for both ganetespib monotherapy and ganetespib in combination with paclitaxel; Evaluate the ORR, CBR, DOR, and PFS with ganetespib and weekly paclitaxel in patients whose disease progresses on ganetespib monotherapy; Determine the qualitative and quantitative toxicities associated with ganetespib and weekly paclitaxel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Female ≥ 18 years of age; 2. Pathologically confirmed diagnosis of invasive breast cancer, classified as HER2-positive, hormone-receptor positive, or TNBC; Inflammatory breast (IBC) is permitted based on the following criteria: clinically evaluable skin disease (erythema, edema, peau d' orange, or ulcerations), with underlying mass detected by PET; and/or the presence of measurable disease detected by CT/MRI - NOTE: If the disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology. 3. Stage IIIB, IIIC or IV disease (AJCC Cancer Staging Manual, 7th edition, 2010)
    NOTE: Lesions should not be amenable to surgery or radiation therapy of curative intent. 4. Prior therapy: Cohort A: Patients with HER2-positive disease must have relapsed following prior trastuzumab or other approved anti-HER2 agent in the adjuvant setting. At least 6 months must have elapsed since the discontinuation of prior adjuvant therapy. Cohort D: Patients with ER- and/or PR-positive disease must have relapsed following at least 1 prior endocrine therapy, in either the adjuvant or metastatic setting. 5. Documented HER2 and hormonal receptor status according to local laboratory analysis. 6. ECOG Performance Status ≤1. 7. A biopsy is to be taken at study entry for all patients with an accessible tumor. Patients with inaccessible tumor may substitute with available archived tumor tissue block with sufficient tumor tissue for biomarker testing; alternatively, unstained slides with sufficient tumor tissue may be substituted. 8. Clinically or radiologically measurable disease - Metastatic disease: - Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, with the exception of patients with IBC for whom disease visible on PET is acceptable. - Measurable disease may be in the field of prior irradiation; however, at least 4 weeks must have elapsed between the completion of radiation therapy and the baseline scan documenting disease status. - Bone disease is considered radiologically measurable only if there is at least a 50% lytic component. NOTE: Bone disease consisting of blastic lesion only is not measurable. - Locally advanced breast cancer - Clinically measurable tumor disease per RECIST 1.1, as detected by physical examination, ultrasound, mammogram, and/or MRI
    NOTE: Patients with a non-palpable primary tumor with histologically confirmed lymph node involvement detected by palpation or ultrasonography are eligible. 9. Adequate hematologic function defined as: Absolute neutrophil count (ANC) ≥1.5 x 109/L; Hemoglobin ≥9 g/dL; Platelets ≥100 x 109/L. 10. Adequate hepatic function defined as: Albumin ≥3 g/dL; Serum total bilirubin ≤1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 x ULN without liver metastases; ≤5 x ULN if documented liver metastases. 11. Adequate renal function defined as: Serum creatinine ≤2.5 mg/dL x ULN or calculated creatinine clearance (CrCl) per Cockcroft-Gault formula ≥50 mL/min (see Appendix 2). 12. Negative serum pregnancy test at study entry for patients of childbearing potential. Patients of childbearing potential must agree to use two adequate contraception methods (eg, hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 30 days after the last dose of study drug. 13. Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1. Prior chemotherapy in the 1st-line setting for MBC NOTE: Prior therapy of IBC patients in the 1st-line setting is permitted given the rarity of the disease. 2. De novo diagnosed patients with HER2+ or ER/PR+ disease. 3. Presence of active or symptomatic or stable untreated CNS metastases - NOTE: Patients with asymptomatic or stable CNS metastases are eligible; 4. Active malignancies other than MBC within the last 5 years except cancers adequately treated with surgery and/or adjuvant therapy. 5. Bone as the only site of metastatic disease from breast cancer; 6. Prophylactic use of supportive therapy for skeletal related events in patients without bone disease - NOTE: Supportive therapy for skeletal-related events (eg, bisphosphonate, pamidronate, or denosumab) is allowed; however, treatment must be initiated prior to, or within 7 days after, the first dose of ganetespib; 7. Prior radiotherapy to the only area of measurable disease, unless there is documented disease progression, defined as an increase of at least 1 cm in the longest diameter compared to nadir scan - NOTE: Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of the first dose of study drug. 8. Pregnancy or lactation. 9. Known serious cardiac illness or medical conditions including but not confined to: i. Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker; ii. Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a Class Ia antiarrhythmic drug (eg, quinidine, procainamide, disopyramide) or Class III antirrhythmic drug (eg, sotalol, amiodarone, dofetilide). Use of other antirrhythmic drugs is permitted; iii. Use of medications that have been linked to QT interval prolongation and the occurrence of torsades de pointes (see Appendix 4 for the list of such medications); iv. Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker; v. Complete left bundle branch block (LBBB); vi. History of long QT Syndrome or a family member with this condition; viii. QTc >470 ms (average of triplicate ECG recordings); a consistent method of QTc calculation must be used for each patient's QTc measurements. QTcF (Fridericia's formula) is preferred. viii. Serum potassium, magnesium, or calcium levels outside the laboratory's reference range. 10. Weight loss ≥10% within the 4 weeks prior to administration of first dose of ganetespib. 11. Unresolved Grade 3 and 4 toxicities from prior cancer therapy. 12. Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV) positive patients receiving combination antiretroviral therapy, severe or systemic infection, or psychiatric illness/social situations that would limit compliance with study requirements; 13. Other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry into the study. 14. History of severe (Grade 3 or 4) allergic or hypersensitivity reactions to excipients (eg, Polyethylene glycol [PEG] 300 and Polysorbate 80). 15. History of intolerance or hypersensitivity ot paclitaxel or its excipients (eg, Cremophor EL).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is objective response rate (ORR), defined as the proportion of evaluable patients in each disease cohort achieving a complete or partial response according to the modified RECIST 1.1 regardless of confirmation (e.g., a single timepoint response will be included in the ORR analysis) within the treatment phase. Up to 33 evaluable patients per cohort will be enrolled. An evaluable patient is defined as having received at least one dose of ganetespib and a subsequent followup scan. Clinical activity analyses will be conducted in both the intent-to-treat (ITT) and per-protocol (PP) populations.
    In general, continuous variables will be summarized by descriptive statistics (number of observations, mean, standard deviation, median, minimum and maximum); categorical variables will be presented with the number of observations and percentage (non-missing) in each category. Kaplan-Meier approach will be used for time-to-event variables.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the treatment phase or beyond.
    E.5.2Secondary end point(s)
    Evaluate the change in F-18 fluorodeoxyglucose (FDG) tumor uptake as a predictor of clinical response following one cycle of treatment with ganetespib monotherapy. Evaluate the clinical benefit rate (CBR), duration of response (DOR), and PFS with ganetespib monotherapy. Determine the qualitative and quantitative toxicities associated with ganetespib monotherapy. Evaluate the relationship of clinical outcome with relevant biomarkers & genetic changes and proteome and transcriptome profiles present in tumor tissues & serum and plasma samples for both ganetespib monotherapy and ganetespib in combination with paclitaxel. Evaluate the ORR, CBR, DOR, and PFS with ganetespib and weekly paclitaxel in patients whose disease progresses on ganetespib monotherapy. Determine the qualitative and quantitative toxicities associated with ganetespib and weekly paclitaxel.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At weeks 3, 6, 12 treatment phase or beyond.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belgium
    Brazil
    Peru
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    End of Regimen is the last visit for any patient with disease progression or until no further benefit is seen with the combination ganetespib–paclitaxel treatment. Patients who are benefitting from this combination therapy will continue for as long as their tumor has not gotten worse or their disease has not progressed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Legally authorized representative of subject may sign consent for patient participation in the study.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 105
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participating patients will continue to receive the combination treatment of ganetespib and paclitaxel as long as their turmor has not gotten worse or their disease has not progressed. If determined that patient's tumor has gotten worse or they are not benefitting from combination treatment will be removed from the study and will discuss other standard of care options with their doctor.
    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 Decision2012-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
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