Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT02629692
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to give written, and dated, informed consent
* Male or female aged ≥ 18 years
* Willing and able to comply with the scheduled visits
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, who are resistant and/or intolerant to ≥ 3 prior TKIs one of which includes ponatinib (Part C).
Exclusion Criteria:
* Presence of T315I (PART C)
* Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
* Inability to undergo venipuncture and/or tolerate venous access
* Positive exclusion tests: urine pregnancy tests (if applicable), HIV, hepatitis B surface antigen, or hepatitis C virus
* Known or suspected history of significant drug abuse as judged by the Investigator
* Received any other investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer of IMP administration
* Subjects who are eligible for potentially curative therapy that is available, including hematopoietic stem cell transplant
* Another primary malignancy within the past 3 years or earlier (except for adequately treated non-melanoma skin cancer or cervical cancer in situ
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02629692
Study Brief:
Protocol Section:
NCT02629692