A Phase 1 Study of LY2835219 In Participants With Advanced Cancer



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/19/2018
Start Date:December 7, 2009
End Date:October 3, 2019

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A Phase 1 Study of a CDK 4/6 Dual Inhibitor in Participants With Advanced Cancer

The purpose of this study is to determine a safe dose of LY2835219 to be given to
participants 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.


Inclusion Criteria:

- For all Parts (Dose escalation and expansion): The participant must be, in the
judgment of the investigator, an appropriate candidate for experimental therapy either
after available standard therapies have ceased to provide clinical benefit (Parts A,
B, C, D, E and F) or in combination with fulvestrant (Part G only)

- 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 and/or
metastatic

- For Dose Expansion (Parts B, C, D, E, F and G): The participant 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: Glioblastoma multiforme that has progressed or recurred after
radiotherapy and/or chemotherapy

- Part D: Breast cancer that is advanced and/or metastatic

- Part E: Melanoma that is advanced and/or metastatic

- Part F: Colorectal Cancer

- Part G: Breast Cancer that is not only advanced and/or metastatic but also
hormone receptor positive

- As defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the
Revised Response Criteria for Malignant Lymphoma

- For Parts A and G: Have measurable or nonmeasurable disease

- For Parts B, C, D, E and F: 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, E, F and G) on the
Eastern Cooperative Oncology Group (ECOG) scale

- Have discontinued all previous therapies for cancer (including chemotherapy,
radiotherapy, immunotherapy, and investigational therapy) with the exception of
fulvestrant (for Part G only) 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

- 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 or sudden cardiac arrest

- 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 central nervous system (CNS) malignancy or
metastasis

- For Dose Confirmation (Parts B, D, E, F and G): Have CNS metastasis that is
radiographically or clinically unstable less than 14 days prior to receiving study
drug, regardless of whether they are receiving corticosteroids

- For Dose Confirmation (Part C): Have glioblastoma multiforme that is radiographically
or clinically unstable less than 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
We found this trial at
3
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San Antonio, TX
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Boston, MA
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Santa Monica, CA
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