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| ID | Type | Description | Link |
|---|---|---|---|
| AGICC 09CRC02 |
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The purpose of this study is to determine whether treatment with Selumetinib (AZD6244) (Hyd-Sulfate) in combination with Irinotecan as a second treatment in patients with K-ras or B-raf mutation will prevent tumor progression and prolong progression free survival.
A Dose Finding and Phase II Study of Selumetinib (AZD6244) (Hyd-Sulfate) in Combination with Irinotecan, in 2nd Line Patients with K-ras or B-raf Mutation Positive Advanced or Metastatic Colorectal Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Selumetinib (AZD6244) in combination with irinotecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6244 | Drug | 50 or 75mg, capsules, PO, BID, 28 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol. | AEs will be assessed at each cycle visit, discontinuation treatment visit, and 30 days post last day of study treatment | |
| Objective Response Rate will be assessed by the RECIST guideline documented in the European Journal of Cancer, 2009. | Tumor evaluation via RECIST guidelines will be done on screening visit, day 22 of every other cycle, and treatment discontinuation visit |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of combination of Selumetinib (AZD6244) with irinotecan by SAE and AE documentation | AEs will be assesed at the screening visit, each cycle visit, treatment discontinuation date, and 30 days post last day of study treatment | |
| PK of Selumetinib (AZD6244), N-desmethyl Selumetinib(AZD6244) and selumetinib (AZD6244) amide in combination with irinotecan |
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Inclusion Criteria:
- Histological or cytological confirmation of advanced or metastatic colorectal cancer with available tissue and tumor sample confirmed as K-ras or B-raf mutation positive. Current failure of 1st line anti-cancer therapy with an oxaliplatin and bevacizumab based regimen or patients relapsing within 12 months of completing adjuvant FOLFOX .
Exclusion Criteria:
- Treatment within 14 days prior to first study treatment with conventional therapy or treatment within 28 days prior to first study treatment with an investigational drug Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen
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| Name | Affiliation | Role |
|---|---|---|
| Howard Hochster, MD | Yale University | Principal Investigator |
| Lawrence Leichman, MD | Desert Regional Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | United States | |||
| Research Site |
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| Irinotecan | Drug | 180mg/m2, IV, Day 1& 15 of each cycle |
|
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| PK sample draws will take place on Day 1 and 15 of first cycle |
| Progression Free Survival (PFS) for patients with K-ras or B-raf mutations treated with combination of irinotecan and Selumetinib (AZD6244) | PFS will be determined via the RECIST guidelines on tumor measurement done on day 22 of every other cycle and on the treatment discontinuation visit |
| Palm Springs |
| California |
| United States |
| Research Site | Aurora | Colorado | United States |
| Research Site | New Haven | Connecticut | United States |
| Research Site | Newark | Delaware | United States |
| Research Site | Miami Beach | Florida | United States |
| Research Site | New York | New York | United States |
| Reserach Site | Chapel Hill | North Carolina | United States |
| Research Site | Greenville | North Carolina | United States |
| Research Site | Washington | North Carolina | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Seattle | Washington | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C517975 | AZD 6244 |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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