A Study for Patients With Pancreatic Cancer
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Purpose
The purpose of the Phase 1 portion of this study is to determine the safe dose of LY2603618 when given 24 hours after gemcitabine. This dose will then be used for the Phase 2 portion of the study. The Phase 2 portion of the study will evaluate whether LY2603618 when administered 24 hours after gemcitabine therapy is an effective treatment for patients with pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Neoplasms |
Drug: LY2603618 Drug: Gemcitabine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic Cancer |
- Phase 1: Determine the maximum tolerated dose for LY2603618 when administered after gemcitabine. [ Time Frame: Time of first dose until 28 days post dose ] [ Designated as safety issue: Yes ]
- Phase 2: overall survival [ Time Frame: Baseline to date of death ] [ Designated as safety issue: Yes ]
- Cmax of gemcitabine and LY2603618 [ Time Frame: Phase 1: During cycles 1 and 2 Phase 2: During cycle 1 ] [ Designated as safety issue: No ]
- Overall tumor response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
- Electrocardiogram QTc prolongation [ Time Frame: Baseline and during Cycle 1 of both Phase 1 and Phase 2 for patients receiving LY2603618 ] [ Designated as safety issue: Yes ]
- Time to disease progression [ Time Frame: Baseline to objective progression ] [ Designated as safety issue: No ]
- Response rate in tumor size at 8 weeks and the relationship with overall survival [ Time Frame: Baseline to date of confirmed response and date of death from any cause ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: baseline to time of discontinuing gemcitabine and/or LY2603618 or baseline to time of starting of new therapy after discontinuing study treatment ] [ Designated as safety issue: No ]
- AUC of gemcitabine and LY2603618 [ Time Frame: Phase 1: During cycles 1 and 2 Phase 2: During cycle 1 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 125 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LY2603618/gemcitabine |
Drug: LY2603618
70-300 mg/m2 intravenous administered once per week for 3 weeks followed by 1 week of rest, repeating every 28 days for a minimum of 2 cycles and until disease progression
Drug: Gemcitabine
1000 mg/m2 intravenous administered once per week for 3 weeks followed by 1 week of rest, repeating every 28 days for a minimum of 2 cycles continuing until disease progression
Other Names:
|
| Active Comparator: Gemcitabine |
Drug: Gemcitabine
1000 mg/m2 intravenous administered once per week for 3 weeks followed by 1 week of rest, repeating every 28 days for a minimum of 2 cycles continuing until disease progression
Other Names:
|
Detailed Description:
Phase 1 will be a dose escalation of doses 70 mg/m2 to 300 mg/m2 divided into 6 cohorts. Each patient will be assigned to a single cohort with no intrapatient dose escalation. Patients will received gemcitabine on days 1, 8, and 15 followed by LY2603618 on days 2, 9, and 16 of each 28 day cycle. The phase 1 portion will enroll approximately 26 patients total to determine the maximum tolerated dose to be carried into the phase 2 portion of the study.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with cancer that is metastatic and/or advanced during Phase 1
- Diagnosed with pancreatic cancer that is metastatic and not amenable to surgery
- Must be 18 years of age
- Adequate hematological, liver, and renal functions
- ECOG status 0-2
Exclusion Criteria:
- Known hypersensitivity to gemcitabine
- Pregnant or lactating females or refusal to use medically approved contraceptive precautions
- Had prior treatment with radiotherapy involving more than 25% of marrow producing area
- Have received treatment in the last 30 days with a drug which has not received regulatory approval for any indication at the time of study entry
Contacts and Locations
Hide Study Locations| United States, Florida | |
| 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. | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Georgia | |
| 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. | |
| Athens, Georgia, United States, 30607 | |
| 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. | |
| Macon, Georgia, United States, 31201 | |
| United States, Idaho | |
| 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. | |
| Post Falls, Idaho, United States, 83854 | |
| United States, Iowa | |
| 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. | |
| Sioux City, Iowa, United States, 51101 | |
| United States, Michigan | |
| 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. | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| 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. | |
| Rochester, Minnesota, United States, 55905 | |
| United States, North Dakota | |
| 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. | |
| Fargo, North Dakota, United States, 58122 | |
| 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. | |
| Danville, Pennsylvania, United States, 17822 | |
| United States, South Dakota | |
| 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. | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Tennessee | |
| 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. | |
| Memphis, Tennessee, United States, 38119 | |
| 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, 78217 | |
| 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. | |
| The Woodlands, Texas, United States, 77380 | |
| 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. | |
| Tyler, Texas, United States, 75702 | |
| United States, Virginia | |
| 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. | |
| Hampton, Virginia, United States, 23666 | |
| United States, Wisconsin | |
| 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. | |
| Green Bay, Wisconsin, United States, 54307 | |
| Germany | |
| 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. | |
| Berlin, Germany, 13353 | |
| 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. | |
| Frankfurt, Germany, 60596 | |
| 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. | |
| Freiburg, Germany, D-79106 | |
| 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. | |
| Hamburg, Germany, 20246 | |
| 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. | |
| Heilbronn, Germany, 74078 | |
| 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. | |
| Nürnberg, Germany, 90419 | |
| Italy | |
| 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. | |
| Ancona, Italy, 60126 | |
| 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. | |
| Firenze, Italy, 50139 | |
| 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. | |
| Mendola, Italy, 47014 | |
| Netherlands | |
| 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. | |
| Amsterdam, Netherlands, 1105 AZ | |
| Romania | |
| 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. | |
| Bucharest, Romania | |
| 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. | |
| Cluj-Napoca, Romania, 400015 | |
| Spain | |
| 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. | |
| Hospitalet De Llobregat, Spain, 08908 | |
| 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. | |
| Madrid, Spain, 28050 | |
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM 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: | NCT00839332 History of Changes |
| Other Study ID Numbers: | 12096, I2I-MC-JMMC |
| Study First Received: | February 6, 2009 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Food and Drug Administration Spain: Ministry of Health |
Keywords provided by Eli Lilly and Company:
|
Pancreas metastatic cancer advanced cancer Pancreatic cancer |
Additional relevant MeSH terms:
|
Neoplasms Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 16, 2013