Colchicine Derivative
CCI-001 for Cancer
Cross Cancer Institute, Edmonton, Canada
CCI-001Phase 1RecruitingLed by Jennifer Spratlin, MDResearch Sponsored by PharmaMatrix Holdings LtdEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Life expectancy of greater than 12 weeks.
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.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Uppatients 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
No Placebo-Only Group
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.
Eligible Conditions
- Recurrent and/or Metastatic Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are expected to live for at least three months (12 weeks).
Select...
The study is looking for patients with specific types of cancer, including bladder, pancreatic, gynecologic, and lung adenocarcinoma.
Select...
You have a confirmed diagnosis of cancer that has come back or spread, and your previous treatments have not been effective. You have either tried all approved therapies or your doctor has determined that this study is a better option than other available treatments.
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.
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a site
Who is running the clinical trial?
University of AlbertaOTHER
858 Previous Clinical Trials
390,055 Total Patients Enrolled
PharmaMatrix Holdings LtdLead Sponsor
Jennifer Spratlin, MDPrincipal Investigator
Alberta Health Services, University of Alberta1 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