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New treatment option for Cancer: Recurrent and/or Metastatic Solid Tumours
Official title A Phase I Open-Label, Single-Arm, Dose-Escalation Clinical and Pharmacology Study of CCI-001 as Monotherapy and in Combination With Standard Chemotherapy in Patients With Recurrent and/or Metastatic Solid Tumours
ClinicalTrials.gov ID: NCT04823897
What this study is testing
What is CCI-001?
CCI-001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cancer: recurrent and/or metastatic solid tumours.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- CCI-001 is a novel colchicine derivative that is being developed by PharmaMatrix Holdings Ltd. (PharmaMatrix).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Unless otherwise noted, apply to all Parts of the protocol.
- Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures.
- Patients must have histologically or cytologically confirmed recurrent or metastatic solid tumours. For Part 1 and Part 2, patients must have disease...
- For Part 3, only patients of the following tumour types will be permitted to enroll: gynecologic cancers (ovarian, fallopian tube, cervical...
- For Part 3, patients' tumours must be deemed to be sensitive to the planned chemotherapy regimens (gemcitabine for pancreaticobiliary adenocarcinomas...
You likely can't join if
- Patients may not be receiving any other investigational agents, chemotherapy, immunotherapy, radiotherapy, or molecular targeted agents within 28...
- Patients previously exposed to CCI-001 are not permitted to re-enroll.
- Patients may not have symptomatic CNS metastasis. Patients with treated CNS metastasis are eligible, provided their disease is radiographically...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-001 such as other derivatives of colchicine.
- History of allergic reactions or intolerance to anticipated chemotherapeutic agents.
- The presence of Grade 2 or higher peripheral neuropathy due to a prior medical condition (such as multiple sclerosis), medications, or other...
See the full eligibility criteria
- Unless otherwise noted, apply to all Parts of the protocol.
- Subject has provided informed consent/assent prior to initiation of any study-specific activities/procedures.
- Patients must have histologically or cytologically confirmed recurrent or metastatic solid tumours. For Part 1 and Part 2, patients must have disease progression on their last treatment, have exhausted available...
- For Part 3, only patients of the following tumour types will be permitted to enroll: gynecologic cancers (ovarian, fallopian tube, cervical, endometrial, vulvar), pancreaticobiliary adenocarcinomas and others (lung...
- For Part 3, patients' tumours must be deemed to be sensitive to the planned chemotherapy regimens (gemcitabine for pancreaticobiliary adenocarcinomas carboplatin for lung adenocarcinomas and gemcitabine or carboplatin...
- Four weeks must have elapsed since prior chemotherapy, hormonal therapy, targeted therapy, or radiation therapy. There is no restriction in the amount of bone marrow previously radiated.
- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
- Recovery to baseline or Grade 1 for all drug-related toxicities due to prior chemotherapy, radiation, hormonal therapy, or molecular targeted therapy, except for alopecia, nausea, diarrhea and constipation.
- Age \>18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<1.
- Life expectancy of greater than 12 weeks.
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count ≥ 1.5 x 10˄9/L/L
- hemoglobin ≥ 90 g/L
- platelets ≥ 100 x 10˄9/L/L
- total bilirubin ≤ 1.5 x Upper limit of normal (ULN)
- AST (SGOT) and ALT(SGPT) ≤ 2.5 x ULN (≤ 5 x ULN for liver metastases)
- Creatinine (Cr) ≤ 1.5 x ULN
- All other laboratory assessments must be ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5.
- Cardiac ejection fraction by echocardiogram must be \>50% for patients at baseline. Any structural changes found must be reviewed by the treating investigator and deemed acceptable and safe prior to study enrolment. Any...
- Baseline ECG with QTc ≤ 470 msec for females and ≤ 450 msec for men.
- Agree to use adequate contraception (see Section 8.7) during the study and for 12 months after receiving the final dose of study drug.
- Ability and willingness to adhere to study-required procedures.
- Patients may not be receiving any other investigational agents, chemotherapy, immunotherapy, radiotherapy, or molecular targeted agents within 28 days prior to enrollment to study.
- Patients previously exposed to CCI-001 are not permitted to re-enroll.
- Patients may not have symptomatic CNS metastasis. Patients with treated CNS metastasis are eligible, provided their disease is radiographically stable over a period of ≥ 8 weeks, asymptomatic, and they are not currently...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-001 such as other derivatives of colchicine.
- History of allergic reactions or intolerance to anticipated chemotherapeutic agents.
- The presence of Grade 2 or higher peripheral neuropathy due to a prior medical condition (such as multiple sclerosis), medications, or other etiologies.
- Any psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Pregnant or nursing women.
- Human Immunodeficiency Virus (HIV)-positive patients.
- Hepatitis B- and/or C-positive patients. A negative test is required at screening.
- History of other invasive cancer within 2 years of study entry. The exceptions are in situ cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin, and localized prostate cancer after curative...
- Patients taking warfarin. Low dose or therapeutic dose of heparin or low molecular weight heparin is allowed.
- Cardiac fibrosis on echocardiogram. Adherence to all inclusion and exclusion criteria is mandatory; no waivers will be granted.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.