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SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer (STEM)

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Evgen Pharma
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Evgen Pharma
ClinicalTrials.gov Identifier:
NCT02970682
First received: November 15, 2016
Last updated: November 21, 2016
Last verified: November 2016
  Purpose

This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.

Patients will be enrolled into one of three study arms (SFX-01 in combination with AI, tamoxifen or fulvestrant) based on their current therapy.


Condition Intervention Phase
Breast Neoplasm Drug: SFX-01 Drug: Fulvestrant Drug: Tamoxifen Drug: Aromatase Inhibitors Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STEM: A Multicentre Phase 2 Study of SFX-01 Treatment and Evaluation in Patients With Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on Either an Aromatase Inhibitor (AI) or Tamoxifen or Fulvestrant

Resource links provided by NLM:


Further study details as provided by Evgen Pharma:

Primary Outcome Measures:
  • Treatment-Emergent Adverse Events [Safety and Tolerability]) [ Time Frame: 24 weeks ]
    To determine the safety and tolerability of SFX-01 in combination with AI, tamoxifen and fulvestrant

  • Clinical benefit rate [ Time Frame: 24 weeks ]
    To determine clinical benefit rate (CBR) (CR+PR+SD) at 24 weeks using RECIST v1.1


Secondary Outcome Measures:
  • Objective Response rate [ Time Frame: 24 Weeks ]
    To determine objective response rate (ORR) (CR+PR) at 24 weeks using RECIST v1.1

  • Time To Response [ Time Frame: 24 weeks ]
    To determine time to response

  • Time to Progression [ Time Frame: 24 Weeks ]
    To determine time to progression (TTP)

  • Progression Free Survival [ Time Frame: 24 Weeks ]
    To determine progression free survival (PFS) at 24 weeks

  • Overall Survival [ Time Frame: 24 Weeks ]
    To determine overall survival (OS) at 24 weeks

  • Clinical Benefit [ Time Frame: 24 Weeks ]
    To determine clinical benefit by measuring duration of response compared to duration of response to prior ET

  • Time to next Treatment [ Time Frame: 24 weeks ]
    To determine time to next treatment


Estimated Enrollment: 60
Study Start Date: October 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aromatase Inhibitor
SFX-01 with Aromatase Inhibitor SFX-01 when used in combination with aromatase inhibitors. All patients will continue to receive their AI and, at the start of the study (D1), patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart, after food (preferably within 2 hours).
Drug: SFX-01
Stabilised Sulforaphane
Other Name: Sulforadex
Drug: Aromatase Inhibitors
Experimental: Fulvestrant
SFX-01 with Fulvestrant SFX-01 when used in combination with fulvestrant. All patients will continue to receive fulvestrant 500 mg IM in 28 day cycles. As patients will already have been taking this, a repeat loading dose is not necessary. Commencing on study D1 patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart, after food (preferably within 2 hours).
Drug: SFX-01
Stabilised Sulforaphane
Other Name: Sulforadex
Drug: Fulvestrant
Fulvestrant
Experimental: Tamoxifen
SFX-01 with Tamoxifen SFX-01 when used in combination with tamoxifen All patients will continue to receive tamoxifen and, at the start of the study (D1), patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart after food (preferably within 2 hours).
Drug: SFX-01
Stabilised Sulforaphane
Other Name: Sulforadex
Drug: Tamoxifen
Tamoxifen

Detailed Description:

The trial is a phase 2, parallel group design in patients with ER positive metastatic breast cancer.

This study will be a multicentre study conducted over an 18 month period. Patients who are taking either a third generation AI, tamoxifen or fulvestrant and have a documented evidence of progressive disease after achieving a best response of stable disease (for at least 6 months) or an objective response of CR or PR on the current treatment indicating the development of secondary resistance to current therapy will be entered into the study having undergone a screening period to continue receiving the same treatment with the addition of SFX-01.

At least 60 patients will be enrolled into one of three arms in a 1:1:1 ratio, i.e. 20 patients per arm. Enrolment will be based on current treatment.

Treatment Arm A: All patients will continue to receive their AI and, at the start of the study (D1), patients will additionally take SFX-01.

Treatment Arm B: All patients will continue to receive tamoxifen and, at the start of the study (D1), patients will additionally take SFX-01

Treatment Arm C: All patients will continue to receive fulvestrant 500 mg IM in 28 day Cycles and, at the start of the study (D1), patients will additionally take SFX-01.

Patient participation will include a Screening Phase, a Treatment Phase, and a Follow-up Phase of up to 28 weeks post D1 of dosing. The Screening Phase will be up to 28 days prior to enrolment. The Treatment Phase will extend from enrolment until the patient is discontinued from study treatment. The Follow-up Phase will be a maximum of 24 weeks and extend from the time of study entry until the patient experiences an event of PD (progressive disease) or relapse (if the patient achieves a CR or PR), initiation of alternate antineoplastic therapy, decision by the patient to completely withdraw from the study or refusal to take part in any further study related procedures or follow-up, or death. Patients who are withdrawn from the study due to adverse events, or reasons other than above and are willing to continue study follow-up procedures can be followed up as per protocol for PD.

All patients progressing prior to week 24 must undergo an EOT visit as per the schedule of assessments

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients 18 years or older (the patient must be the legal age limit to give informed consent within the jurisdiction the study is taking place in);
  2. Patients with histologically confirmed estrogen receptor positive (ER+) breast cancer. ER is considered positive if a percentage score of ≥10% of tumour cells staining positive for ER;
  3. Histological confirmation of HER2 negative breast cancer on primary tumour at diagnosis or on biopsy of a metastasis. HER2 negative is defined by the ASCO/CAP guidelines;
  4. Patients with clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection;
  5. Patients must have at least one site of measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) ≥ 10 mm with spiral CT scan or MRI scan (malignant lymph nodes should be ≥15mm to be considered measurable); all sites of disease should be noted and followed in accordance with RECIST v1.1. (A lytic or mixed lytic-blastic bone lesion with a soft tissue component assessed on CT/MRI can be measurable if the minimum size criteria are met. Blastic bone lesions and bone lesions assessed on bone scan, positron emission therapy (PET) or plain films are non-measurable);
  6. Patients must have an anticipated life expectancy of at least 12 weeks;
  7. Adequate bone marrow, renal and hepatic function defined as:

    • Haemoglobin > 9 g/dL;
    • Absolute neutrophil count > 1.0 x 109/L;
    • Platelets > 100 x 109/L;
    • Total bilirubin within normal limits, except those with Gilberts syndrome for whom this must be <2.5 x ULN;
    • AST(SGOT) or ALT(SGPT) < 2.5 x ULN;
    • Calculated creatinine clearance > 30 ml/min (Appendix 2);
  8. Eastern Cooperative Oncology Group (ECOG) performance status < 2;
  9. Must currently be on either a third generation aromatase inhibitor, tamoxifen or fulvestrant and have a documented evidence of progressive disease after:

    1. taking ET as adjuvant therapy for >2 years or
    2. achieving a best response of stable disease (for at least 6 months) or an objective response of CR or PR on the current treatment both indicating the development of secondary resistance to current therapy;
  10. Suitable for continuing endocrine therapy according to the treating clinician. The window of discontinuation must not exceed 4 weeks.
  11. All patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
  12. No more than 2 prior lines of endocrine therapy for the metastatic breast cancer;
  13. No more than one prior line of chemotherapy/targeted therapy for metastatic/locally advanced breast cancer;
  14. Patients with adequately controlled hepatitis C or hepatitis B surface antigen;
  15. No residual toxicity > grade 1 from prior antineoplastic therapy with the exception of peripheral neuropathy or neuropathic pain which must be stable (as per investigator assessment);
  16. Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g., barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 6 months after final administration of study drug. Note that sterility in female patients must be confirmed in the patients' medical records and be defined as any of the following: surgical hysterectomy or bilateral oophorectomy, bilateral tubular ligation, natural menopause with last menses >1 year ago; radiation induced oophorectomy with last menses >1 year ago; chemotherapy induced menopause with 1 year interval since last menses; male patients whose female partner(s) is (are) pregnant must use a condom from the time of the first administration of SFX-01 until 3 months following administration of last dose;
  17. Female patients of childbearing potential must have a negative serum or urine pregnancy test at day 1 of the study.

Exclusion Criteria:

  1. Rapidly progressive visceral disease not suitable for further endocrine therapy;
  2. Currently on chemotherapy or any other combination treatment for their MBC other than AI, tamoxifen or fulvestrant;
  3. Radiotherapy less than 2 weeks prior to study entry;
  4. Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of study treatment;
  5. Spinal cord compression or brain metastases unless treated and radiologically stable for > 6weeks post treatment and not requiring steroids for at least 4 weeks prior to start of study treatment;
  6. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required;
  7. Refractory nausea and vomiting, patients with malabsorption syndrome, diseases significantly affecting gastrointestinal function, resection of the stomach or small bowel, or difficulty in swallowing and retaining oral medications;
  8. An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures;
  9. Patients with unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment;
  10. Diagnosed or treated for a malignancy other than breast cancer within 1 year, or who were previously diagnosed with a malignancy other than breast cancer and have any radiographic or biochemical marker evidence of malignancy. Patients with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy (other than breast) are not excluded.
  11. Concurrent treatment with another investigational agent or participated in another investigational trial unless adequate washout period per the investigational drug PK has been achieved (usually this is 5 half lives of a product);
  12. Ovarian function suppression therapy is not an exclusion for females who are premenopausal and on ET and can be continued throughout study;
  13. Females who are pregnant, wishing to become pregnant or breast feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02970682

Contacts
Contact: David W Howat, PhD +441517053532 d.howat@evgen.com
Contact: Dave Chadwick, NHSTDI. +441517053532 d.chadwick@evgen.com

Locations
Belgium
Saint-Luc hospital, Brussels Recruiting
Woluwe-Saint-Lambert, Belgium, 1200
Contact: Francois Duhoux, MD PhD    +3227645435    francois.duhoux@uclouvain.be   
Czech Republic
Univerzita Karlova, Onkologicka klinika Not yet recruiting
Prague, Czech Republic, 12808
Contact: Martina Zimovjanova, MD.PhD    420 224 966 764    martina.zimovjanova@vfn.cz   
France
ICO René Gauducheau, St Herblain Not yet recruiting
Nantes, Loire Atlantique, France, 44805
Contact: Mario Campone, MD    02 40 67 99 77    m-campone@nantes.fnclcc.fr   
Spain
Granollers Hospital, Granollers, Not yet recruiting
Barcelona, Spain
Contact: Vanessa Ortega,,, MD    +34938425000 ext 6052    vortega@fhag.es   
United Kingdom
The Christie NHS Foundation Trust Not yet recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: Sacha Howell, MB BS PhD    44 161 4463000      
Contact       Sacha.Howell@christie.nhs.uk   
Sponsors and Collaborators
Evgen Pharma
Premier Research Group plc
Investigators
Study Chair: Sacha Howell, MD PhD The Christie NHS Foundation Trust
  More Information

Responsible Party: Evgen Pharma
ClinicalTrials.gov Identifier: NCT02970682     History of Changes
Other Study ID Numbers: EVG001BC
Study First Received: November 15, 2016
Last Updated: November 21, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Fulvestrant
Estradiol
Aromatase Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Estrogen Receptor Antagonists
Estrogens
Hormones
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 20, 2017