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Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
This is a research study of clofarabine that will be given to patients (orally) with advanced cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer effective or no reliable effective treatment is available.
The purpose of this study is to find the answers to the following research questions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single-arm, dose escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clofarabine (oral formulation) | Drug | Cohorts of 3 patients each were to receive oral clofarabine administered daily for 5 days followed by 23 days of rest (1 cycle) and repeated every 28 days depending on toxicity and response. The starting dose of clofarabine was to be 1 mg/m2/day with subsequent dose escalation to occur in increments of 50% for the first 5 dose levels (1.5, 2.25, 3.5, and 5.0 mg/m2/day) and in increments of 25% thereafter until the MTD/RP2D was determined. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose (MTD)/recommended phase II dose (RP2D) and dose limiting toxicity (DLT) of oral clofarabine when administered once daily for 5 days every 28 days to adult patients with locally advanced or metastatic solid tumors | Length of Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mary Crowley Medical Research Center | Dallas | Texas | 75246 | United States | ||
| Tyler Cancer Institute |
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| Label | URL |
|---|---|
| US FDA Approved Full Prescribing Information for Clolar® | View source |
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| ID | Term |
|---|---|
| D000077866 | Clofarabine |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| Tyler |
| Texas |
| 75702 |
| United States |
| Cancer Care Northwest | Spokane | Washington | 99218 | United States |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |