Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1, nonrandomized, open-label, dose-escalation study of 3-hour IV infusions of RH-1 administered to patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL).
Treatment will continue until a patient meets criteria for discontinuation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RH-1 | Drug | 1.5 mg/m2 to 12 mg/m2, depending on protocol cohort, administered via intravenous (IV) infusion over 3 hours once every 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of a 3-hour intravenous (IV) infusion of RH-1 administered once every 21 days. | Study duration |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of 3-hour IV infusions of RH-1. | Study duration | |
| To determine the pharmacokinetic (PK) profile of 3-hour IV infusions of RH-1 administered at escalating doses. | Study duration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| D. Ross Camidge, MD, PhD | University of Colorado Health Science Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health Science Center | Aurora | Colorado | 80010 | United States | ||
| Hudson-Webber Cancer Research Center |
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C117776 | 2,5-diaziridinyl-3-(hydroxymethyl)-6-methyl-1,4-benzoquinone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| To assess preliminary evidence of anti-cancer activity of RH-1. | Study duration |
| To explore evidence of differential deoxyribonucleic acid (DNA) cross-linking and downstream phenotypic consequences of RH-1 exposure in peripheral blood mononuclear cells (PBMCs), circulating tumor cells (CTCs), and tumor biopsies. | Study duration |
| To explore the correlation and possible significance of germline polymorphisms in NAD(P)H:quinone oxidoreductase (NQO1) and DNA cross-linking as consequences of RH-1 exposure in PBMCs, CTCs, and tumor biopsies, as markers of anticancer activity. | Study duration |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Cancer Therapy & Research Center | San Antonio | Texas | 78229 | United States |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |