A Phase 1 Study of LY2835219 In Subjects With Advanced Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01394016
• Date of registration: 12/07/2011
• Primary sponsor: Eli Lilly and Company
• Public title: A Phase 1 Study of LY2835219 In Subjects With Advanced Cancer
• Scientific title: A Phase 1 Study of a CDK 4/6 Dual Inhibitor in Patients With Advanced Cancer
• Date of first enrolment: December 2009
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01394016
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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: 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

- 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, 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

- For Dose Confirmation (Parts B, D, and E): 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Cancer

Intervention(s)

Drug: LY2835219

Primary Outcome(s)

Number of participants with clinically significant effects (physical assessments and safety lab tests) [Time Frame: Baseline through study completion (approximately 38 months)]

Secondary Outcome(s)

Number of participants with tumor response [Time Frame: Baseline through study completion (approximately 38 months)]

Pharmacokinetics, area under the curve (AUC) [Time Frame: Days -3, -2, -1, Days 1, 15, 28, and 29 of Cycle 1]

Pharmacokinetics, maximum plasma concentration (Cmax) [Time Frame: Days -3, -2, -1, Days 1, 15, 28, and 29 of Cycle 1]

Recommended dose for phase 2 studies [Time Frame: Baseline to study completion (approximately 38 months)]

Secondary ID(s)

13199

I3Y-MC-JPBA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors