Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00415636
First received: December 21, 2006
Last updated: August 30, 2010
Last verified: August 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: IC83/LY2603618 Drug: pemetrexed |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Dose-Escalation Study to Examine the Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Safety and Tolerability of IC83/LY2603618 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic parameters will be determined. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Antitumor activity will be observed. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 31 |
| Study Start Date: | December 2006 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: IC83/LY2603618
- Alimta
- LY231514
40 mg/m2 day 1 and day 9 cycle 1, day 2 of subsequent cycles, unlimited 21 day cycles. Dose finding study: dose is escalated after a minimum of 6 patients receive 40 mg/m2.
Drug: pemetrexed
pemetrexed 500 mg/m2, IV, day 8 of cycle 1, day one of subsequent cycles, unlimited 21 day cycles
Other Names:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Has at least one lesion that can be evaluated by RECIST
- Has fully recovered from all toxicities due to the following:
- Has a life expectancy of at least 3 months.
- Negative serum pregnancy test.
Exclusion Criteria:
- Is pregnant or breastfeeding.
- Is a woman of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
- Is a man of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
- Has a history of brain metastases, unless adequately treated and without radiologic evidence of progressive disease for at least 3 months after completion of therapy.
- Has a known active infection.
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: NCT00415636
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415636
Locations
| United States, Arizona | |
| 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. | |
| Scottsdale, Arizona, United States, 85258 | |
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 9AM-5PM Eastern time (UTC/GMT-5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00415636 History of Changes |
| Other Study ID Numbers: | 11911, I2I-MC-JMMB |
| Study First Received: | December 21, 2006 |
| Last Updated: | August 30, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors |
Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015