Orelabrutinib (ICP-022) for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic, Rochester, MN
Cancer+2 More
Orelabrutinib (ICP-022) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat certain types of cancer.

See full description

Eligible Conditions

  • Cancer
  • Part 2:B-cell Malignancies
  • Part 1:r/r B-cell Malignancies

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Orelabrutinib (ICP-022) will improve 2 primary outcomes and 5 secondary outcomes in patients with Cancer. Measurement will happen over the course of Incidence of dose limiting toxicities (DLTs) up to 28 days.

Day 28
Part 1 Dose Escalation:The maximum tolerated dose (MTD)
Up to 2 years
Part 1 Dose Escalation:Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]
Part 1 Dose Escalation:ORR
Part 1 Dose Escalation:T1/2
Part 2 Dose Expansion:DOR
Part 2 Dose Expansion:Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]
Part 2 Dose Expansion:ORR

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Part 2 Dose Expansion
1 of 2
Part 1 Dose Escalation
1 of 2
Experimental Treatment

This trial requires 81 total participants across 2 different treatment groups

This trial involves 2 different treatments. Orelabrutinib (ICP-022) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Part 2 Dose Expansion
Drug
Arm 1: Patients with r/r MCL Arm 2: Patients with other types of B-cell malignancies, including: CLL/SLL with/without prior treatment r/r FL r/r MZL
Part 1 Dose Escalation
Drug
Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Mayo Clinic - Rochester, MN

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 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL.
Signed Informed Consent.
Age ≥ 18 years.
Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
Life expectancy (in the opinion of the investigator) of ≥ 4 months.
ECOG performance status of 0 ~1.
Must have adequate organ function.
Negative test results for HBV ([HBsAg (-)] and non-active HBV or HCV infection

Patient Q&A Section

What is cancer?

"Although the exact reasons for cancer remain unknown, several factors are known to contribute to its development. In contrast, cancer is treated successfully by various modalities." - Anonymous Online Contributor

Unverified Answer

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

"The American Cancer Society estimates 274,000 new diagnoses of cancer will be made in 2018 in the United States alone. This makes up 22% of all new cancer diagnoses in America. It is estimated there will be 24,000 fewer cancer-related deaths in 2018 compared to 2014. A significant part of these new patients will die from breast and colorectal cancer due to advances in the early-detection of these cancers.\n" - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"It can be curable, but the question remains as to how. Some people can be cured but in all cases an ongoing challenge is to cure cancers that do recur. Clearly, the best time for this is during the early stage before there is any spread of disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"The most  common signs of cancer include persistent cough, shortness of breath and  a lump. An abdominal mass may be palpable, and this may signify a gastrointestinal cancer.  \n" - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"It is not clear why cancer seems to prefer women, why cancer seems to be genetically inherited, or why men are at a much higher risk of developing cancer after the age of 60. Recent findings point to viruses as a common cause of cancer, particularly cervical cancer and possibly some kinds of cancers of the breast and prostate. \n\n- Cancer in India\n- List of cancers in India\n- List of cancers\n\n1. Pachamalinga Rao, M B, ed. Clinical Oncology, vol." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"A number of cancer treatments are used to treat cancer, including a variety of therapies like chemotherapy and medical radiotherapy, and the use of innovative medical treatments. Many cancer treatments are provided free of charge by patients themselves. A variety of cancer treatments exist which are available to patients depending on the type of cancer being treated. For instance, the most common treatment for cancer is chemotherapy. There are treatments for cancer patients of all ages including childhood cancer, children's cancer, adult cancer, and cancer in older adults." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving orelabrutinib (icp-022)?

"Given the poor clinical results and the toxicity profile for IPC-022 across multiple studies and indications, we would argue against further development of this agent in this indication." - Anonymous Online Contributor

Unverified Answer

Does cancer run in families?

"Considering the prevalence of cancer in the family, it is unlikely, but not impossible, for families to have two or more first-degree relatives who have been diagnosed with cancer." - Anonymous Online Contributor

Unverified Answer

Is orelabrutinib (icp-022) safe for people?

"A Phase I study of orelabrutinib in elderly subjects demonstrated manageable side effects and provided a framework for evaluating phase II safety, activity, and clinical relevance for patients ≥60 years of age." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cancer?

"The majority of patients undergoing surgery experienced improvement in cancer related symptoms, but there were also few patients with no improvement in symptoms. A small percentage of patients showed a worsening of symptoms. There was no significant difference in the symptoms that improved for patients with different types of tumors. Patients with large bowel cancer had fewer improvements in symptoms compared with those with other types of tumors. Patients with the advanced type of lung cancer had fewer improvements in symptom related to lung cancer. There was no difference in the amount of patients who gained weight from chemotherapy and those who lost weight from chemotherapy. Patients who received chemotherapy, had fewer improvements in symptoms, had worse symptoms on the day of chemotherapy, and had more nausea and vomiting after chemotherapy had more adverse events at any time interval." - Anonymous Online Contributor

Unverified Answer

How does orelabrutinib (icp-022) work?

"Combined with ixabepilone, orelabrutinib has significant activity in preclinical models of advanced solid tumors, both in the presence and absence of other mutations, and, while clinically evaluated in a phase II trial in patients with advanced gastrointestinal malignancies, was generally well tolerated and did not appear to compromise response rates to other targeted agents." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer?

"Recent findings should help providers to better understand their patients' needs when it comes to making decisions regarding clinical trials, especially for treatment-intense cancers such as metastatic cancer and leukemia. Recent findings suggested that patients with a history of cancer should be considered when discussing clinical trials. They may need individualized information and may be in a position to evaluate the risk vs benefit. Moreover, patients with cancer should be addressed in regard to the type and dosage of cancer therapy available to them, as well as their likelihood for obtaining and responding to medical therapy." - Anonymous Online Contributor

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