A Study for Patients With Pancreatic Cancer
Status: | Completed |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 9/23/2012 |
Start Date: | March 2009 |
End Date: | May 2013 |
Contact: | There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or |
Phone: | 1-317-615-4559 |
A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic Cancer
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.
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.
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
We found this trial at
16
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