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Clinical Trial 20404

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03363893

Phase: Phase I/II
Prinicipal Investigator: Heather Han

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Study Title

A Modular, Multipart, Multi-arm, Open-label, Phase 1/2a Study to Evaluate the Safety and Tolerability of CT7001 Alone and in Combination with Anti-Cancer Treatments in Patients with Advanced Malignancies


This is a modular, Phase I/II, multicentre study to investigate CT7001 monotherapy in advanced solid malignancies and to further investigate CT7001 as monotherapy or in combination with standard therapy in specific participant groups with Triple Negative Breast Cancer (TNBC), Castrate Resistant Prostate Cancer (CRPC) and in combination with fulvestrant for patients with hormone receptor-positive (HR+ve) / human epidermal growth factor-2 negative (HER2-ve) breast cancer.


Primary Objective, study Part A To determine the recommended Phase 2 dose of CT7001 given in combination with fulvestrant at 500 mg. Primary Objective, study Part B To compare the efficacy of CT7001 given in combination with fulvestrant versus fulvestrant plus placebo. Primary Objective, study Part C To evaluate the efficacy of CT7001 combined with fulvestrant in patients whose disease had progressed on or after fulvestrant plus placebo in Part B of the study




CT7001 (); Faslodex (fulvestrant); Placebo (); fulvestrant ()

Inclusion Criteria

  • Core Inclusion Criteria:
  • ECOG performance status 0 or 1 with no deterioration over the previous 2 weeks
  • Estimated life expectancy of greater than 12 weeks
  • Ability to swallow and retain oral medication
  • Women either of non-childbearing potential or of childbearing potential willing to practice effective contraception for the duration of the study and for 6 months (Module 1, Module 4) and 24 months (Module 2) after the last dose of CT7001 Sexually active male patients must be willing to use condoms with all sexual partners for the duration of the study and for 3 months after the last dose of CT7001.
  • Provision of signed and dated, written informed consent

  • Exclusion Criteria

  • Core Exclusion Criteria:
  • Any other malignancy that has been active or treated within the past 3 years, with the exception of cervical intraepithelial neoplasia and non-melanoma skin cancer
  • Any unresolved toxicity (except alopecia) from prior therapy of ≥ CTCAE Grade 2
  • Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring steroids for at least 4 weeks before the first dose of investigational product (IP)
  • Refractory nausea and vomiting, chronic gastrointestinal (GI) disease or previous significant bowel resection, with clinically significant sequelae that would preclude adequate absorption of CT7001
  • Uncontrolled seizures
  • Active infection requiring systemic antibiotic, antifungal, or antiviral medication
  • Severe or uncontrolled medical condition or psychiatric condition
  • Active bleeding diatheses
  • Renal transplant
  • Known hepatitis B, hepatitis C, or human immunodeficiency virus infection
  • Breastfeeding or pregnancy
  • Receipt of cytotoxic treatment for the malignancy within 28 days or ≤ 5 half-lives, whichever is shorter before the first dose of IP
  • Receipt of non-cytotoxic treatment for the malignancy within 5 half-lives of the drug before the first dose of IP
  • Receipt of corticosteroids (at a dose > 10 mg prednisone/day or equivalent) within 14 days before the first dose of IP
  • Receipt of any small-molecule investigational medicinal product (IMP) within 28 days or ≤ 5 half-lives, whichever is shorter before the first dose of IP
  • Receipt of any biological IMP (e.g., immune checkpoint blockers, antibodies, nanoparticles) within 42 days before the first dose of IP
  • Receipt of St John's Wort within 21 days before the first dose of IP or of another concomitant medication, herbal supplement, or food that is a strong inhibitor or inducer of CYP3A4, CYP2C19, CYP2D6, or P-glycoprotein (PGP) activity within 14 days before the first dose of CT7001
  • Receipt of a blood transfusion (blood or blood products) within 14 days before the first dose of IP
  • Known hypersensitivity to CT7001 or any excipient of the product
  • Impaired hepatic or renal function as demonstrated by laboratory values per protocol
  • Liver function deteriorating in a manner that would likely make the participant meet the AST, ALT, or bilirubin levels specified above at the time of the first dose of IP
  • Other evidence of impaired hepatic synthesis function
  • Inadequate bone marrow reserve or organ function as demonstrated by laboratory values per protocol
  • Persistent (> 4 weeks) severe pancytopenia due to previous therapy rather than to disease (ANC > Cardiac dysfunction (defined as myocardial infarction within 6 months of study entry, New York Heart Association Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias, or left ventricular ejection fraction > Mean resting QT interval corrected for heart rate by the Fridericia formula (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs) obtained within 5 minutes of each other prior to the first dose
  • Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, third degree heart block). Controlled atrial fibrillation (AF) is permitted
  • Any factor that increases the risk of QTc prolongation or of arrhythmic events (e.g., heart failure, hypokalaemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death under 40 years of age)
  • In the opinion of the Investigator, unlikely to comply with study procedures, restrictions, or requirements
  • A history of haemolytic anaemia or marrow aplasia
  • Has received a live-virus vaccination within 28 days or less of planned treat

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