What side effects are associated with this type of intervention?

Common treatments for cancer that involve tubulin binding disruption, such as paclitaxel and carboplatin, often have side effects including neuropathy, myelosuppression (reduced bone marrow activity leading to fewer blood cells), nausea, vomiting, and fatigue. Paclitaxel is particularly associated with sensory neuropathy and myalgias, while carboplatin is known for causing thrombocytopenia (low platelet count) and less severe renal toxicity compared to cisplatin. These side effects can vary in severity and impact patients' quality of life, necessitating careful management and sometimes dose adjustments.

What prior FDA approvals exist?

FDA-approved cancer treatments that involve tubulin binding disruption include taxanes such as paclitaxel and docetaxel, and vinca alkaloids like vincristine and vinblastine. These agents interfere with microtubule function, essential for cell division, and are used in treating various cancers, including breast, ovarian, lung, and hematologic malignancies. These drugs share a similar mechanism of action to CCI-001, a novel colchicine derivative currently under investigation.

What other types of research exist?

Promising novel alternatives to CCI-001 for cancer treatment include Combretastatin A-4 (CA4) and its pro-drug CA4P, which inhibit tubulin polymerization by binding to the colchicine-binding site, and STX2484, an orally bioavailable microtubule-disrupting agent with efficacy in taxane-resistant breast cancer models.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments often target cellular processes critical for tumor growth and survival. Tubulin-binding agents, like the novel colchicine derivative CCI-001, disrupt microtubule formation, which is essential for cell division and mitosis. This disruption can halt the proliferation of cancer cells. Other common treatments include DNA-damaging agents (e.g., cisplatin), which induce cell death by causing irreparable DNA damage, and immune checkpoint inhibitors (e.g., anti-PD-1 therapy), which enhance the immune system's ability to recognize and destroy cancer cells. Understanding these mechanisms is crucial for cancer patients as it informs treatment choices and potential side effects, ultimately aiding in personalized and effective cancer care.

Evidence that Extreme Dilutions of Paclitaxel and Docetaxel Alter Gene Expression of In Vitro Breast Cancer Cells.Cellular and molecular determinants of cisplatin resistance.