CCI-001 for Cancer

Overseen By Charles Allard

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: PharmaMatrix Holdings Ltd

Must not be taking: Corticosteroids, Anticonvulsants, Warfarin

Disqualifiers: CNS metastases, Cardiac fibrosis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, CCI-001, which targets a protein needed for cell division. It aims to find the safe dose and see how well it works in patients with various advanced cancers.

Will I have to stop taking my current medications?

The trial requires that you stop taking any investigational agents, chemotherapy, immunotherapy, radiotherapy, or molecular targeted agents at least 28 days before enrolling. If you are taking warfarin, you will need to stop, but low-dose or therapeutic heparin is allowed.

Research Team

Jennifer Spratlin, MD

Principal Investigator

Alberta Health Services, University of Alberta

Eligibility Criteria

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.

Inclusion Criteria

Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures

I am 18 years old or older.

Life expectancy of greater than 12 weeks

Exclusion Criteria

I am on warfarin or low-dose heparin treatments.

Pregnant or nursing women

Human Immunodeficiency Virus (HIV)-positive patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

CCI-001 is administered at escalating doses to determine the maximum tolerated dose

28 days

Cycle 1 Days 1 and 15, Cycle 2 Day 1

Dose Expansion

Patients with specific tumour types are treated at the recommended dose determined during dose escalation

28 days

Cycle 1 Days 1 and 15, Cycle 2 Day 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Imaging every 8 weeks

Treatment Details

Interventions

• CCI-001

Trial Overview 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.

Participant Groups

Group I: Dose Escalation and Expansion Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

PharmaMatrix Holdings Ltd

Lead Sponsor

Trials

1

Recruited

70+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+