Moffitt Cancer Center: Clinical Trial 20404

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Clinical Trial 20404

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

Phase: Phase I/II
Prinicipal Investigator: Heather Han

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

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

Summary

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.

Objective

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

Treatments

Therapies

Medications

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

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.