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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT01564251
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable
* Life expectancy greater than or equal to (\>=) 12 weeks, in the opinion of the investigator
* Adequate hematologic, liver, and renal function
* For Stage 2: Participants with human epidermal growth factor receptor 2 (HER2) negative, estrogen-receptor (ER) negative, and progesterone-receptor (PR) negative breast cancer
* For Stage 2: Participants with non-mucinous, platinum-resistant ovarian cancer with documented radiographic progression or relapse according to RECIST within 6 months of receiving platinum-based chemotherapy
* For Stage 2: Participants with histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC); mixed histology that is predominantly squamous is acceptable
Exclusion Criteria:
* History of prior significant toxicity from a same class of agents as GDC-0575 or gemcitabine requiring discontinuation of treatment
* All acute toxicities related to prior therapy must have resolved prior to study entry, except for alopecia and mild neuropathy
* Current severe, uncontrolled systemic disease (including but not limited to clinically significant cardiovascular, pulmonary, or renal disease or ongoing or active infection) excluding the cancer under study
* History of significant cardiac dysfunction
* History of malabsorption or other condition that would interfere with enteral absorption
* Known human immunodeficiency virus (HIV) infection
* Pregnancy, lactation or breastfeeding
* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
* Current use of alpha-adrenergic receptor blockers
For Combination Arm only:
* Any contraindication to gemcitabine therapy
* More than two regimens of cytotoxic chemotherapy for the treatment of locally advanced or metastatic cancer
* History of receiving high-dose chemotherapy requiring bone marrow or stem cell support
* Irradiation to more than 25% of bone marrow-bearing areas
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01564251
Study Brief:
Protocol Section:
NCT01564251