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| ID | Type | Description | Link |
|---|---|---|---|
| 120ST101 |
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This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and pharmacodynamics study.
Heat shock protein 90 (Hsp90) is an ubiquitous molecular chaperone protein that is involved in folding, activation, and assembly of many proteins, including key mediators of signal transduction, cell cycle control, and transcriptional regulation. In cancer cells that are dependent upon Hsp90 client proteins, the degree to which clients are inhibited correlates closely with induction of growth inhibition and apoptosis with Hsp90 inhibitory drugs. The active pharmaceutical ingredient of CNF2024, CF1983 mesylate, is a synthetic, new chemical entity designed to inhibit Hsp90. CF1983 hada strong affinity for tumor derived Hsp90 and weaker affinity for Hsp90 isolated from normal cells or recombinant Hsp90.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing Schedule 1 | Other | Starting dose of 25 mg, with dosing twice a week for 3 weeks out of a 4-week course (Schedule 1). Dosing for schedule 1 is currently closed. |
|
| Dosing Schedule 2 | Other | Starting dose of 600 mg, with dosing twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNF2024 | Drug | CNF2024 capsules administered orally following 2 schedules:
Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation proceeds according to the predetermined scheme until the stopping dose is reached due to a dose limiting toxicity (DLT) occurring during the first 4-week course of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose (MTD) | Dose escalation will proceed according to the predetermined scheme until the stopping dose (dose > MTD) is reached due to dose limiting toxicities (DLT) occurring during the first 4-week course of treatment. | |
| To determine the safety profile | Study duration | |
| pharmacokinetic profile | Dosing period | |
| effect on pharmacodynamic biomarkers | Dosing period | |
| antitumor activity | At screening and after every 2 courses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Biogen Idec Medical Monitor, MD | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Scottsdale | Arizona | 85258 | United States | ||
| Research site |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C521963 | 6-chloro-9-(4-methoxy-3,5-dimethylpyridin-2-ylmethyl)-9H-purin-2-ylamine |
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|
|
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Research site | San Antonio | Texas | 78245 | United States |
| Research site | Sutton | Surrey | SM2 5PT | United Kingdom |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |