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:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT01695005
Eligibility Criteria:
Inclusion Criteria:
* For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.
* For Dose Escalation (Part A): The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic.
* For Part B: All participants must have a histological evidence of their advanced or metastatic cancer and prescreened alterations in a defined pathway.
* For Part C: All participants must have histological evidence of advanced or metastatic specific subtypes of soft tissue sarcoma.
* For Part D: All participants must have histological evidence of advanced or metastatic cancer and prescreened alterations in a defined pathway.
* Cohort 1: Participants must have triple negative breast cancer.
* Cohort 2: Participants must have hepatocellular carcinoma (HCC). These participants should have Child-Pugh stage A.
* Cohort 3: Participants must have cholangiocarcinoma.
* Cohort 4: Participants must have chronic lymphocytic leukemia.
* Cohort 5: Participants must have a mature T cell, B cell, or natural killer (NK) cell neoplasm.
* For Part E: Participants must have adenoid cystic carcinoma (ACC).
* For Part F dose confirmation: Participants must have leiomyosarcoma and prescreened alterations in a defined pathway.
* As defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the Revised Response Criteria for Malignant Lymphoma or the Response Assessment in Neuro Oncology (RANO) criteria for glioblastoma:
* For Dose Escalation (Part A): Have measurable or nonmeasurable disease.
* For Parts B, C, D, E and F: Have measurable disease or reliable biomarker measure.
* For Parts B, C, D, E and F: Have available tumor tissue.
* Have adequate organ function.
* Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale and life expectancy of more than 12 weeks.
Exclusion Criteria:
* Have symptomatic or non stable central nervous system (CNS) malignancy.
* Females who are pregnant or lactating.
* Have active bacterial, fungal, and/or known viral infection.
* Have malabsorptive syndromes, enteropathies, gastroenteritis (acute or chronic), or diarrhea (acute or chronic).
* Participants with HCC that:
* Have known HCC with fibro-lamellar or mixed histology.
* Have presence of clinically relevant ascites.
* Have had a liver transplant.
* Have active or uncontrolled clinically serious hepatitis B virus or hepatitis C virus infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01695005
Study Brief:
Protocol Section:
NCT01695005