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    Summary
    EudraCT Number:2012-005170-65
    Sponsor's Protocol Code Number:MK-8109-004
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-08-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-005170-65
    A.3Full title of the trial
    A Phase IIa Open Label, Randomized Clinical Trial to Study the Safety and Efficacy of Vintafolide and the Combination of Vintafolide and Paclitaxel Compared to Paclitaxel in Subjects with Advanced Triple Negative Breast Cancer Using Etarfolatide (EC20) Subject
    Selection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIa Open Label, Randomized Clinical Trial to Study Vintafolide and Paclitaxel in Subjects with Advanced Triple Negative Breast Cancer Using SPECT/CT scan with Etarfolatide (EC20) for Subject Selection
    A.3.2Name or abbreviated title of the trial where available
    Vintafolide and vintafolide plus paclitaxel compared to paclitaxel alone in subjects with TNBC using
    A.4.1Sponsor's protocol code numberMK-8109-004
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive
    B.5.3.2Town/ cityWhitehouse Station
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number2673053326
    B.5.5Fax number2673051255
    B.5.6E-mailemmett.schmidt@merck.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 nameMK-8109
    D.3.2Product code MK-8109
    D.3.4Pharmaceutical form Powder for solution for injection
    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.3.9.1CAS number 74209-03-1
    D.3.9.2Current sponsor codemk-8109
    D.3.9.3Other descriptive nameEC145, folic acid desacetylvinblastine hydrazine conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.8
    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 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 nameEC20
    D.3.2Product code EC20
    D.3.4Pharmaceutical form Powder for solution for injection
    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.3.9.1CAS number 479578-27-3
    D.3.9.2Current sponsor codeEC20
    D.3.9.3Other descriptive name99mTc EC20, folic acid-technetium 99m conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 PACLIT
    D.2.1.1.2Name of the Marketing Authorisation holderCancernova GmbH onkologische Arzneimittel
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namePACLIT
    D.3.2Product code paclitaxel
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.1CAS number 33069-62-4
    D.3.9.3Other descriptive nameTaxol
    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
    Triple Negative Breast Cancer (advanced breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective)
    E.1.1.1Medical condition in easily understood language
    Triple Negative (ER-, PR-, HER2-) 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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the progression-free survival of vintafolide monotherapy relative to paclitaxel and the progression-free survival of vintafolide + paclitaxel combination therapy relative to paclitaxel in subjects with advanced triple negative breast cancer whose target lesions are 100% positive for folate receptor expression using etarfolatide scans.
    E.2.2Secondary objectives of the trial
    1. To assess the frequency of triple negative breast cancer subjects whose target tumors express FR(100%) versus FR(10-90%) versus FR(0%) using etarfolatide scans. 2. To determine the correlation between FOLR1 mRNA expression in tumors in subjects with advanced triple negative breast cancer and subject etarfolatide target lesion scores (FR[100%], FR[10-90%], FR[0%]) measured by etarfolatide.
    3. To compare the clinical activity of vintafolide monotherapy versus paclitaxel and the clinical activity of vintafolide + paclitaxel combination therapy versus paclitaxel in subjects with advanced triple negative breast cancer as measured by Overall Response Rate, Clinical Benefit Rate, and Overall Survival.
    4. To assess the safety and tolerability of vintafolide monotherapy versus the combination of vintafolide and paclitaxel versus paclitaxel monotherapy in subjects with advanced triple negative breast cancer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female subjects must have histologically or cytologically confirmed ER-, PR-, HER2 – advanced breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
    - Have developed progressive disease following at least 1 (and not more than 4) prior chemotherapeutic regimens for breast cancer, which was administered for treatment of locally recurrent and/or metastatic disease
    - At least 1 regimen must have included a taxane (e.g. paclitaxel or docetaxel) in any combination or order. Prior taxane may have been administered as adjuvant and/or neoadjuvant therapy.
    - Subject is ≥ 18 years of age on day of signing informed consent
    - Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    - Have at least a single (RECIST 1.1 defined) measurable lesion
    - All tumor target lesions characterized as FR(100%) using etarfolatide screened assessed by central core facility.
    E.4Principal exclusion criteria
    Has had chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration or who has not recovered (≤Grade 1 or baseline) from adverse events due to agents administered more than 4 weeks earlier.
    - Is currently participating or has participated in a study with an investigational compound or device within 28 days of initial dosing on this study.
    - Has received more than 4 prior cytotoxic regimens for metastatic disease.
    - Has a primary central nervous system (CNS) tumor.
    - Has active CNS metastases and/or carcinomatous meningitis. However, subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids or on a stable dose of steroids for at least 2 weeks.
    - Has had prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds.
    - Has known hypersensitivity to the components of the study therapy or its analogs. This includes paclitaxel, docetaxel, other taxane therapies, drugs formulated with polyoxyethylated castor oil (Cremphor EL), vinlastine, or other vinca-derived therapies.
    - Has pre-existing neuropathy > Grade 2. Subjects with residual drug-induced neuropathy of ≤2 will be eligible if it has stable, and not worsening, for at least 30 days.
    - Has a bowel occlusion or subocclusion.
    - Has had prior abdominal or pelvis radiation therapy or radiation therapy to > 10% of the bone marrow at any time in the past or prior radiation therapy within the last three years to the breast/sternum, dermal lesions, head, or neck.
    - Requires anti-folate therapy for the management of co-morbid conditions (e.g., rheumatoid arthritis).
    - Has symptomatic ascites or pleural effusion. A subject who is clinically stable following treatment for these conditions is eligible for the study however.
    - Has had a prior stem cell or bone marrow transplant
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis will be to evaluate PFS which is generally accepted as an endpoint (or the closely related time to progression [TTP] endpoint) for clinical trials in patients with breast cancer.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS will be assessed throughout the study and measured as the time from randomization to the time of disease progression or death. Patients will receive imaging assessments at 8 week intervals throughout the study to assess response.
    E.5.2Secondary end point(s)
    1. Overall Response Rate (ORR): Disease response will be assessed throughout the study by anatomic imaging evaluation and physical exam of visible/palpable tumor. Overall tumor response will be assessed using Enhanced RECIST 1.1 at the designated time points. The portion of patients with tumor size reduction predefined by RECIST 1.1, including patients with complete response (CR) and partial response (PR), will be evaluated.
    2. Clinical Benefit Rate (CBR): Disease control rates (DCR), which include stable disase (SD) as a response measure offer additional advantages over ORRs, since they are also associated with overall survival (OS) in breast cancer. During clinical development of Eribulin, SD lasting > 6 months was used to assess CBR as CR + PR + SD (≥6 months). Since the same criteria were used to assess vintafolide activity in initial monotherapy trials in ovarian cancer, the CBR for this trial will be defined as CR + PR + SD (≥6 months).
    3.Overall Survival (OS): OS data defined as the time from randomization until death from any cause will be collected as a universally accepted direct measure of benefit.
    4. Safety: The study will use standard endpoints that allow one to see results in context for comparison with large historical databases. Safety and tolerability of vintafolide in multiple indications will be assessed in advanced cancer subjects. Monitoring will include complete blood counts, serum chemistry, vital signs, physical exam, ECGs, and ECOG performance status.
    5. Pharmackokinetic Endpoints: For the initial dose of vintafolide and paclitaxel for each subject, plasma concentration-time profiles will be determined following IV administration. The following PK parameters will be determined for vintafolide and paclitaxel: maximum observed plasma concentration (Cmax); area under the plasma concentration-time curve (AUC); and if feasible, half-life (t1/2); total body clearance (CL) and volume of distribution (Vd). In addition, descriptive statistics of plasma concentrations at designated time points will be provided.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR and CBR will be assessed throughout the study through physical exams performed at the beginning of each cycle and by anatomic imaging performed every 8 weeks throughout the study.
    Subjects will be followed for OS at 3 month intervals via telephone contact for a minimum of 24 months and a maximum of 60 months from randomization.
    Safety: Complete blood counts will be monitored weekly throughout the study, serum chemistry assessment at week 1 and week 3 of every cycle, vital signs (prior to each dose), physical examination,ECGs, and ECOG performance status (once per cycle) . All toxicity will be graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events-CTCAE, Version 4.

    "Refer to protocol for complete list."
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Paclitaxel
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Brazil
    Canada
    Denmark
    France
    Italy
    Korea, Republic of
    Russian Federation
    South Africa
    Spain
    Sweden
    United Kingdom
    United States
    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
    The overall trial ends when the last subject completes the last trial visit, a minimum of 6 months post initial study medication administration have elapsed, or the last subject either discontinues from the trial or is lost to follow-up (i.e., the subject is unable to be contacted by the investigator), whichever comes first.
    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 months6
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days11
    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: 68
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 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 37
    F.4.2.2In the whole clinical trial 102
    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)
    When a subject discontinues/withdraws from the study, all applicable activities scheduled for the final trial visit should be performed at the time of discontinuation. Any adverse events which are present at the time of discontinuation/withdrawal should be followed in accordance with the safety requirements outlined in the protocol (Section 7.2 - Assessing andRecording Adverse Events).
    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 Decision2013-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-06-18
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