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Colchicine Derivative

CCI-001 for Cancer

Phase 1

Recruiting

Led By Jennifer Spratlin, MD

Research Sponsored by PharmaMatrix Holdings Ltd

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 patients will have a baseline scan prior to dosing, and re-evaluated with imaging every 8 weeks. to continue from baseline scan to first documented date of disease progression, or date of death from any cause, to a maximum of 36 months.

Awards & highlights

Study Summary

This trial is testing a new drug, called CCI-001, to see if it is safe for humans and to find the best dose. The drug is designed to attack cancer cells by binding to a protein that is important for cell division. The trial will also look at how well the drug works against different types of cancer.

Who is the study for?

Adults with certain types of recurrent or metastatic solid tumors, who have tried other treatments without success or for whom no standard treatment exists. They must be in good health otherwise, with normal organ and marrow function, and not currently receiving other cancer therapies. Women can't be pregnant or nursing, and all participants must agree to use contraception.Check my eligibility

What is being tested?

CCI-001 is a new drug related to colchicine being tested for safety and effective dosage in patients with specific cancers that are known to respond to similar drugs. This first-in-human trial will also look at how the body processes CCI-001 and its impact on tumor size and patient survival.See study design

What are the potential side effects?

Potential side effects aren't detailed here but could relate to the drug's action on cell division which might include nausea, fatigue, hair loss (alopecia), nerve damage (neuropathy), or allergic reactions due to its similarity to colchicine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients will have a baseline scan prior to dosing, and re-evaluated with imaging every 8 weeks. to continue from baseline scan to first documented date of disease progression, or date of death from any cause, to a maximum of 36 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients will have a baseline scan prior to dosing, and re-evaluated with imaging every 8 weeks. to continue from baseline scan to first documented date of disease progression, or date of death from any cause, to a maximum of 36 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will have a baseline scan prior to dosing, and re-evaluated with imaging every 8 weeks. to continue from baseline scan to first documented date of disease progression, or date of death from any cause, to a maximum of 36 months. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To assess the safety and tolerability of intravenously infused CCI-001 in patients with recurrent and/or metastatic solid tumours by determining the dose-limiting toxicity (DLT) of the compound.

To determine, during the dose escalation phase, the recommended dose of intravenously infused CCI-001 for the dose expansion phase of the trial.

Secondary outcome measures

To determine the area under the curve (AUC) of CCI-001 administered intravenously.

To determine the maximum plasma concentration (Cmax) of CCI-001 administered intravenously.

To determine the terminal half life (t1/2) of CCI-001 administered intravenously.

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention

Dose escalation phase: CCI-001 will be administered at the starting dose to a cohort of patients with recurrent and/or metastatic solid tumours. The dose will be escalated sequentially in subsequent cohorts to determine the maximum tolerated dose, or recommended dose for the dose expansion cohort. Dose expansion phase: patients with the following tumour types will be permitted to enroll: transitional cell bladder cancer, pancreaticobiliary adenocarcinomas, gynecologic cancers (ovarian, cervical, endometrial), and lung adenocarcinoma. These patients will be treated at the dose determined during the dose escalation phase.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaOTHER

888 Previous Clinical Trials

384,888 Total Patients Enrolled

PharmaMatrix Holdings LtdLead Sponsor

Jennifer Spratlin, MDPrincipal InvestigatorAlberta Health Services, University of Alberta

1 Previous Clinical Trials

47 Total Patients Enrolled

Frequently Asked Questions

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

To what extent is this trial being participated in by individuals?

"Affirmative. According to the information posted on clinicaltrials.gov, enrollment is currently open for this medical trial which was initially shared on July 26th 2021 and last updated on July 12th 2022. A total of 70 patients must be recruited from a single centre."

Answered by AI

What objectives are the researchers hoping to accomplish with this experiment?

"The core aim of this biomedical trial is to identify the optimal dosage for intravenously delivered CCI-001 during Cycle 1 (28 days). Additional objectives include assessing patient survival rates, determining response rate based on RECIST 1.1 criteria and calculating the terminal half life of CCI-001 in patients' plasma."

Answered by AI

Has CCI-001 been sanctioned by the FDA?

"Since this is a Phase 1 trial, the safety of CCI-001 was estimated to be a score of 1 due to limited data backing its efficacy and security."

Answered by AI

Are there any open enrollment opportunities for this trial?

"The clinical trial, which was uploaded to clincialtrials.gov on July 26th 2021 and last revised on the 12th of July 2022, is still in need of participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CCI-001 in Patients With Recurrent and/or Metastatic Solid Tumours

2021. "A Study of CCI-001 in Patients With Recurrent and/or Metastatic Solid Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04823897.