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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00002002 | Other Identifier | JHMIRB |
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All consented subjects tested negative for the BRCA2 mutation, therefore, did not meet criteria to start the study, resulting in withdrawal by PI
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| Name | Class |
|---|---|
| Van Andel Research Institute | OTHER |
Patients will be tested for mutations in the BRCA2 gene. If they have a BRCA2 mutation, they will be treated with Mitomycin-C as described here. The patients with an identified gene mutation will also be provided with genetic counseling.
Patients will be tested for mutations in the BRCA2 gene. If they have a BRCA2 mutation, they will be treated with Mitomycin-C as described here. The patients with an identified gene mutation will also be provided with genetic counseling.
Patients with BRCA2 gene will be treated with Mitomycin-C (MMC) on Day 1 at a dose of 10mg/m2 intravenously. This will be repeated every 28 days, which is one cycle. Expected adverse events and appropriate dose modifications are described in this section. Treatment will continue until disease progression, serious toxicity, patient withdrawal or maximum cumulative dose of 60 mg/m2.
Primary Objectives:
1. To determine the 6-month survival of patients with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations that are treated with single agent Mitomycin-C (MMC) chemotherapy.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients with BRCA2 gene will be treated with Mitomycin-C (MMC) on Day 1 at a dose of 10mg/m2 intravenously. This will be repeated every 28 days, which is one cycle. Treatment will continue until disease progression, serious toxicity, patient withdrawal or maximum cumulative dose of 60 mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitomycin-C | Drug | Mitomycin C, finds use as a chemotherapeutic agent by virtue of its antitumour antibiotic activity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month overall survival | Number of participants with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations that are alive after 6-months after being treated with single agent Mitomycin-C (MMC) chemotherapy. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Proportion of participants with reduction in tumor burden of previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations who are treated with single agent MMC chemotherapy. | up to 2.5 years |
| Progression-free survival at 6 months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Hidalgo, MD, PhD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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Number of participants who are treated with single agent MMC chemotherapy and have partial or complete response of previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations. |
| up to 6 months |
| Progression-free survival | Number of participants who are treated with single agent MMC chemotherapy and have partial or complete response of previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations. | up to 2.5 years |
| Overall survival | Number of participants with previously untreated advanced or recurrent adenocarcinoma of the pancreas with BRCA2 mutations who are alive after being treated with single agent MMC chemotherapy. | up to 2.5 years |
| Toxicity as assessed by number of participants experiencing adverse events. | Up to 2.5 years |
| To explore pharmacogenetic factors that may influence the toxicity and efficacy of MMC in this patient population. | 2.5 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |