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A Study of LY2801653 in Advanced Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01285037
First received: January 26, 2011
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to participants with advanced cancer and to determine any side effects that may be associated with LY2801653 in this participant population. Efficacy measures will be used to assess the activity of LY2801653.

Part B- The dose determined in Part A will be used along with efficacy measures to assess the activity of LY2801653 in participants with adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma (HNSCC), uveal melanoma with liver metastasis, and cholangiocarcinoma.

Part C - the objective of Part C is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with HNSCC when taken with standard doses of cetuximab

Part D - the objective of Part D is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with a standard dose of cisplatin


Condition Intervention Phase
Cancer
Drug: LY2801653
Drug: Cetuximab
Drug: Cisplatin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY2801653 in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended dose for phase 2 studies: Maximum tolerated dose [ Time Frame: Baseline to study completion (estimated as 3 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with tumor response [ Time Frame: Baseline to study completion (estimated as 3 months) ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant effects [ Time Frame: Baseline to study completion (estimated as 3 months) ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Area under the concentration/time curve (AUC) [ Time Frame: Cycle 1, Day 1; Cycle 2, Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum plasma concentration (Cmax) [ Time Frame: Cycle 1, Day 1; Cycle 2, Day 1 ] [ Designated as safety issue: No ]
  • Maximum tolerated dose (MTD) of LY2801653 in combination with cetuximab for phase 2 studies in HNSCC [ Time Frame: Baseline to study completion (estimated as 3 months) ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose (MTD) of LY2801653 in combination with cisplatin for phase 2 studies in cholangiocarcinoma [ Time Frame: Baseline to study completion (estimated as 3 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: November 2009
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2801653

This study consists of a dose escalation of LY2801653 (Part A) followed by dose confirmation cohorts in four tumor types (adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma, uveal melanoma with liver metastasis, and cholangiocarcinoma) (Part B).

Part C consists of dose determination for LY2801653 in combination with cetuximab in participants with head and neck squamous cell carcinoma followed by an expansion cohort.

Part D consists of dose determination for LY2801653 in combination with cisplatin in participants with cholangiocarcinoma followed by an expansion cohort.

Drug: LY2801653
LY2801653 given orally once daily during 28-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Drug: Cetuximab
Cetuximab given via IV infusion once weekly, 400mg/m2 for first dose and 250mg /m2 for subsequent doses. If LY2801653 treatment is stopped due to toxicity after a minimum of 4 cycles, Cetuximab may be continued until disease progression. In the event Cetuximab treatment is stopped, participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
Drug: Cisplatin
25mg/m2 Cisplatin given via IV infusion once a week for 2 weeks and then every 3 weeks. If the LY2801653 is terminated for LY2801653-related toxicity after a minimum of 4 cycles, Cisplatin may be continued as monotherapy until progression of disease. Participants discontinuing Cisplatin therapy may be allowed to continue single agent LY2801653 if they are receiving clinical benefit.

Detailed Description:

Parts C and D were added to the registration in November, 2013, per protocol amendment.

  Eligibility

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

Inclusion Criteria:

  • Part A- Diagnosed with advanced and/or metastatic cancer during dose escalation
  • Part B- Diagnosed with adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma, uveal melanoma with liver with metastasis, or cholangiocarcinoma
  • Part C - Diagnosed with head and neck squamous cell carcinoma and have received at least one prior platinum-based systemic therapy
  • Part D - Diagnosed with cholangiocarcinoma and have not received more than 1 prior systemic therapy
  • Must be at least 18 years of age
  • Adequate hematologic, renal, and liver functions
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Ability to swallow capsules, with the exception of head and neck squamous cell carcinoma participants who may have study drug crushed and administered through a feeding tube

Exclusion Criteria:

  • Have serious preexisting medical conditions that would preclude participation in the study
  • Have a chronic underlying infection
  • Have symptomatic central nervous system (CNS) malignancy or metastasis
  • Have current acute or chronic leukemia
  • Are pregnant or lactating
  • Have hepatocellular cancer, liver cirrhosis with a Child-Pugh stage of B or higher, or have received a liver transplant
  • Have a history of congestive heart failure with a New York Heart Association class greater than 2, unstable angina, recent myocardial infarction (within 6 months of study enrollment), transient ischemic attacks, stroke, or arterial or venous vascular disease
  • Have a QTc interval greater than 470 msec
  • For participants in Part B, C, and D a tumor tissue sample is mandatory for biomarker analysis
  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: NCT01285037

Contacts
Contact: There may be multiple sites in this clinical trial. (1-877-CTLILLY (1-877-285-4559)) or (1-317-615-4559)

Locations
United States, District of Columbia
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. Recruiting
Washington, District of Columbia, United States, 20007
Contact: Eli Lilly         
United States, New York
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. Recruiting
New York, New York, United States, 10029
Contact: Eli Lilly         
United States, Pennsylvania
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. Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Eli Lilly         
United States, Rhode Island
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. Recruiting
Providence, Rhode Island, United States, 02903
Contact: Eli Lilly         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-817-285-4559) or 1-317-615-4559 Mon - Fri 9AM to 5PM Eastern time (UTC/GMT - 5hours, EST) Eli Lilly and Company
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01285037     History of Changes
Other Study ID Numbers: 13008, I3O-MC-JSBA
Study First Received: January 26, 2011
Last Updated: September 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cetuximab
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014