CCI-001 for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Cross Cancer Institute, Edmonton, Canada
Cancer+2 More
CCI-001 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether CCI-001 is safe and can be given to patients with cancer.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Relapse
  • Recurrence
  • Cancer: Recurrent and/or Metastatic Solid Tumours

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether CCI-001 will improve 6 primary outcomes and 2 secondary outcomes in patients with Cancer. Measurement will happen over the course of Cycle 1 (28 days).

Cycle 1 (28 days)
To determine the dose-limiting toxicity (DLT) of intravenously infused CCI-001 in patients with recurrent and/or metastatic solid tumours.
To determine, during the dose escalation phase, the recommended dose of intravenously infused CCI-001 for the dose expansion phase of the trial.
Day 28
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.
To determine the time to maximum plasma level (Tmax) of CCI-001 administered intravenously.
Month 36
To evaluate the clinical response rate in patients treated with CCI-001 with recurrent and/or metastatic solid tumours, with particular attention to those in expansion cohorts
Day 30
To evaluate survival in patients treated with CCI-001 with recurrent and/or metastatic solid tumours, with particular attention to those in expansion cohorts

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Dose Escalation and Expansion

This trial requires 70 total participants across 2 different treatment groups

This trial involves 2 different treatments. CCI-001 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dose Escalation and Expansion
Drug
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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 has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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.

Closest Location

Cross Cancer Institute - Edmonton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have histologically or cytologically confirmed recurrent or metastatic solid tumours. Patients must have disease progression on the last treatment exposed to, have exhausted available approved lines of therapy or better-characterized therapies that, at the discretion of the investigator, is felt to be more appropriate therapy, or have malignancies for which there are no approved therapies. For the dose-expansion phase of the study, only those 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.
Age ≥18 years.
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.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1.
total bilirubin ≤ 1.5 X upper limit of normal (ULN)
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.
Life expectancy of greater than 12 weeks.
absolute neutrophil count ≥ 1,500/mcL
hemoglobin ≥ 90 g/L
platelets ≥ 100,000/mcL

Patient Q&A Section

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

What are the signs of cancer?

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many signs of cancer are associated with systemic disease such that they are rarely specific for a malignancy. As is almost always the case with clinical signs, it is difficult to decide from the findings which symptom, if any, reflects the presence of a particular condition.

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Can cancer be cured?

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Cancer may be cured. The key to a cure is detection and early intervention. If the early detection, and early intervention of cancer had occurred the cure would have been achieved decades ago. Early detection and early intervention is still necessary. The development of new detection approaches of cancer is essential. Current detection does not have good correlation with cure. For example CT scans and x-ray imaging can discover early bone metastases in breast cancer, but a cure has not been documented yet.

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What is cancer?

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While the disease is named to describe it pathogenesis, it remains a disease characterized by the abnormal growth of cells that have the tendency to invade other cells.

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How many people get cancer a year in the United States?

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Around 17 million US adults had cancer in 2016-2017 at some point in their lifetime, of whom 12 million were found to have cancer in any given year. This makes up 10.8% of US adults.

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What causes cancer?

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As in many other jurisdictions, a relatively small proportion of patients diagnosed and treated for cancer have a familial predisposition (5.1% in this study). Thus, while there is no evidence of a hereditary basis to cancer, some hereditary predispositions to cancer may be identified. As in recent epidemiological studies, cancer survivors, both men and women, are at increased risk of subsequent breast cancer (about two-fold).

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What are common treatments for cancer?

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The majority of patients with cancer receive at least one type of therapy. Results from a recent paper, most patients received standard therapies such as surgery, chemotherapy, radiation therapy, or targeted therapy. The overall quality of care was low, with only half of the treatment sessions being documented in the medical record. Future studies should examine whether and what constitutes high quality care for cancer treatments.

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Who should consider clinical trials for cancer?

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It is a common belief that the elderly do not want to enroll in clinical trials. Older patients or patients with comorbidities or other disabilities may have a higher risk for participating in clinical trials. Therefore, the possibility of enrollment should be discussed with patients or their primary care physicians.

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Have there been other clinical trials involving cci-001?

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There have been three other large phase III studies (START-1 (E7771), STOMP-1 (E7772) and STOMP-2 (E7773)) investigating the efficacy of cci-001 in patients with previously untreated metastatic breast cancer (MBC) whose tumors had HER2 overexpression (HER2+) by IHC assay. Overall, the STOMP groups as a whole, and STOMP-1 in particular, reported higher responses with cci-001 than with comparator regimens. However, the STOMP trials did not disclose the time for progression (TTP) or overall survival data.

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What is cci-001?

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Cci-001 can be safely administered by intravenous infusion twice every 15 minutes over the next 2 hours. Dose adjustment based on serum creatinine and absolute creatinine clearance do not need to be made. There were no serum or urine changes detected.

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Does cancer run in families?

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The majority of family members with cancer share the same profile for age at onset and smoking history, which is consistent with recent studies of twins. These shared profiles could be considered part of the familial cancer aetiology.

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How serious can cancer be?

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The seriousness of cancer depends not only on histology but also on the site and stage of involvement, the person's overall health, their age and other risk factors.

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