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 @ 12:25 PM
Ignite Modification Date:
2025-12-24 @ 12:25 PM
NCT ID:
NCT01920061
Eligibility Criteria:
Inclusion Criteria:
Cisplatin Combination Expansion:
Arm 1:Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting; Arm 2: Patients with TNBC and one or two prior cytotoxic therapies in the metastatic setting.
* Arm A: castrate resistant prostate cancer, advanced breast cancer, or non-small cell lunch cancer that are candidates for treatment with a docetaxel-based combination.
* Arm B: Urothelial transitional cell cancer, triple negative breast cancer, ovarian cancer or non small cell lunch cancer that are candidates for a cisplatin-based combination.
* Arm C: Her2+ breast cancer refractory to prior herceptin or lapatinib, her2+ esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch cancer that are candidates for treatment with a dacomitinib-based combination.
* Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available.
* Eastern Cooperative Oncology Group \[ECOG\] performance must be 0 or 1.
* Adequate bone marrow, renal and liver function.
Exclusion Criteria:
* Prior therapy for Cisplatin Combination Expansion:
* Prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic setting;
* Prior radiation to \>25% bone marrow as estimated by the Investigator.
* Patients with known symptomatic brain metastases.
* Chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the lead-in dose.
* Major surgery within 4 weeks of the baseline disease assessments.
* \>2 prior regimens containing cytotoxic chemotherapy in the metastatic setting.
* Active bacterial, fungal or viral infection.
* Uncontrolled or significant cardiovascular disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01920061
Study Brief:
Protocol Section:
NCT01920061