A Phase 1 Study of LY2835219 In Subjects With Advanced Cancer

Status: Recruiting
Phase:
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01394016 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-017

 

The purpose of this study is to determine a safe dose of LY2835219 to be given to patients with advanced cancer and to determine any side effects that may be associated with LY2835219 in this population. Efficacy measures will be used to assess the activity of LY2835219 in this population.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute

Overall PI:
Keith Flaherty, MD, Massachusetts General Hospital

Site-responsible Investigators:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Contacts:
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - For all Parts (Dose escalation and expansion): The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have ceased to provide clinical benefit for their disease - For Dose Escalation (Part A): The patient must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced and/or metastatic - For Dose Expansion (Parts B, C, D, and E): The patient must have histological or cytological evidence of one of the following cancers: - Part B: Non-small cell lung cancer of any subtype that is advanced and/or metastatic - Part C: Colorectal cancer that is advanced and/or metastatic - Part D: Breast cancer that is advanced and/or metastatic - Part E: Melanoma that is advanced and/or metastatic - As defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)or the Revised Response Criteria for Malignant Lymphoma - For Dose Escalation (Part A): Have measurable or nonmeasurable disease - For Dose Confirmation (Parts B, C, D, and E): Have measurable disease - Have given written informed consent prior to any study-specific procedures - Have adequate hematologic, hepatic, and renal function - Have a performance status less than or equal to 1 for Dose Escalation (Part A) and less than or equal to 2 for Dose Confirmation (Parts B, C, D, and E) on the Eastern Cooperative Oncology Group (ECOG) scale - Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment related toxicity resolved to baseline) except for residual alopecia. At the discretion of the investigator, patients with breast or prostate cancers progressing on endocrine therapies may have that treatment continued while receiving study drug - Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures - Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug - Females with child bearing potential must have a negative serum pregnancy test within 3 days of the first dose of study drug - Have an estimated life expectancy of greater than or equal to 12 weeks - Are able to swallow capsules Exclusion Criteria: - Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively. - Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), sudden cardiac death, sudden cardiac arrest, myocardial infarction, coronary artery bypass grafting, or congestive heart failure - Have an abnormal electrocardiogram (ECG) - Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel) - For Dose Escalation (Part A): Have CNS malignancy or metastasis Screening of asymptomatic patients without history of CNS metastases is not required for enrollment For Dose Confirmation (Parts B, C, D, and E): Have symptomatic CNS malignancy or metastasis. Patients with previously-treated CNS malignancy or metastasis are eligible if they are not currently receiving anticoagulants and their disease is radiographically stable for at least 14 days prior to receiving study drug, regardless of whether they are receiving corticosteroids - Have an acute leukemia - Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug - Females who are pregnant or lactating - Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies) Screening is not required for enrollment
  • Email
  • Print
  • Share
  • Text
Highlight Glossary Terms