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CT7001 for Solid Tumors

Phase 1 & 2

Waitlist Available

Led By Matthew Krebs, MBChB PhD

Research Sponsored by Carrick Therapeutics Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening to end of study

Awards & highlights

Study Summary

This trial is testing a new drug, CT7001, for different types of cancer, both alone and in combination with other drugs.

Eligible Conditions

Advanced Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after the first dose and during the dosing period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after the first dose and during the dosing period

This trial's timeline: 3 weeks for screening, Varies for treatment, and after the first dose and during the dosing period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability)

Secondary outcome measures

Anti-tumour Activity according to RECIST v1.1

Area Under the Curve (AUC)

Biological Activity Parameters (Biomarkers) in Peripheral Blood

+3 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Module 4Experimental Treatment1 Intervention

Participants with advanced solid tumours will receive CT7001(samuraciclib) oral monotherapy in a randomized, balanced, single-dose, two-treatment (fed v fasting), two-period, two-sequence crossover study followed by once daily continuous dosing.

Group II: Module 2 Part AExperimental Treatment2 Interventions

Participants with locally advanced or metastatic HR+ve and HER2-ve breast cancer will receive CT7001 (samuraciclib) at the dose, frequency and schedule recommended from Module 1 part A and will receive Fulvestrant solution in pre-filled syringe for intramuscular (IM) injection

Group III: Module 1 Part B-2 Castrate resistant prostate Cancer (CRPC) ExpansionExperimental Treatment1 Intervention

Participants with castrate resistant prostate cancer will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.

Group IV: Module 1 Part B-1 Triple-negative breast cancer (TNBC) ExpansionExperimental Treatment1 Intervention

Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) will receive CT7001(samuraciclib) as oral monotherapy at the dose, frequency and schedule recommended from Module 1 Part A.

Group V: Module 1 Part A Paired Biopsy Breast Cancer Expansion CohortExperimental Treatment1 Intervention

Participants with locally advanced or metastatic breast cancer will receive CT7001 (samuraciclib) as oral monotherapy at the minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).

Group VI: Module 1 Part A Multiple ascending dose cohortExperimental Treatment1 Intervention

Participants with advanced solid tumours receive CT7001 (samuraciclib) as oral monotherapy, in ascending dose cohorts, to identify the maximum tolerated dose (MTD), minimally biologically active dose (MBAD) and recommended dose for Phase II testing (RP2D).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3690

CT7001

2017

Completed Phase 2

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Carrick Therapeutics LimitedLead Sponsor

3 Previous Clinical Trials

175 Total Patients Enrolled

Matthew Krebs, MBChB PhDPrincipal InvestigatorThe Christie Hospital, Manchester, UK

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which conditions is CT7001 typically prescribed?

"Endocrine therapy is frequently treated with CT7001, and this medication can also be utilized to combat diseases such as breast cancer and Pik3ca gene mutation."

Answered by AI

What other investigations have explored the efficacy of CT7001?

"CT7001 was initially trialled in 2004 at Lowell General Hospital, and has since seen 88 completed clinical studies. Currently, 134 trials are taking place across the nation of which many have been initiated by medical centres located in New york City."

Answered by AI

What is the size of the patient cohort being observed in this clinical trial?

"This trial is closed to new applicants. It was first posted on November 14th 2017 and last updated on October 17th 2022. For those seeking other medical studies, there are 2374 trials for advanced solid malignancies that still accept participants as well as 134 trials for CT7001."

Answered by AI

How many geographical sites are offering this research project?

"This clinical project has 19 sites participating, including Research Site 55 in New york City, Research Site 51 in Fort Worth and Research Site 43 in Charleston. There are also 16 other locations taking part as well."

Answered by AI

Is this experiment actively enlisting participants at the present time?

"This particular research endeavour is no longer seeking enrolment, as it was first posted on November 14th 2017 and last updated October 17th 2022. Those who are looking for other clinical trials can find 2374 studies actively recruiting participants with advanced solid malignancies and 134 investigations that require CT7001 trial members."

Answered by AI

Recent research and studies

Cancer and Metastasis ReviewsJournal

CDK7 Inhibitors as Anticancer Drugs

Sava, Georgina P., Hailing Fan, R. Charles Coombes, Lakjaya Buluwela, and Simak Ali. 2020. “CDK7 Inhibitors as Anticancer Drugs”. Cancer and Metastasis Reviews. Springer Science and Business Media LLC. doi:10.1007/s10555-020-09885-8.

clinicaltrials.govStudy

Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies

2017. "Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03363893.