A Phase 1 Study of LY2835219 In Participants With Advanced Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01394016
First received: July 12, 2011
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Advanced Cancer
Drug: LY2835219
Drug: Fulvestrant
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of a CDK 4/6 Dual Inhibitor in Participants With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with clinically significant effects (physical assessments and safety lab tests) [ Time Frame: Baseline through study completion (approximately 38 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with tumor response [ Time Frame: Baseline through study completion (approximately 38 months) ] [ Designated as safety issue: No ]
  • Pharmacokinetics, maximum plasma concentration (Cmax) [ Time Frame: Days -3, -2, -1, Days 1, 15, 22, 28 and 29 of Cycle 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, area under the curve (AUC) [ Time Frame: Days -3, -2, -1, Days 1, 15, 22, 28 and 29 of Cycle 1 ] [ Designated as safety issue: No ]
  • Recommended dose for phase 2 studies [ Time Frame: Baseline to study completion (approximately 38 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: December 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2835219 Drug: LY2835219
Administered orally, daily for 28-day cycles for two planned cycles. For Part G only in addition to LY2835219 as above, fulvestrant is administered as specified in the label. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Drug: Fulvestrant
Fulvestrant is administered intramuscularly into the buttocks as specified in the label in Part G only.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394016

Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santa Monica, California, United States, 90404
United States, Massachusetts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Boston, Massachusetts, United States, 02115
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01394016     History of Changes
Other Study ID Numbers: 13199, I3Y-MC-JPBA
Study First Received: July 12, 2011
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Fulvestrant
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 22, 2014