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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by (Responsible Party): | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT01145989 |
Purpose
The purpose of this study is to find out whether the new drug AT9283 will slow the growth of multiple myeloma. Side effects of AT9283 will also be closely monitored.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: AT9283 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of AT9283 in Patients With Relapsed or Refractory Multiple Myeloma |
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AT9283
Starting dose will be 40 mg/m2/day OR 30 mg/m2/day to be confirmed at registration. IV 24 hour continuous infusion Days 1 and 8 every three weeks
|
Drug: AT9283
Starting dose will be 40 mg/m2/day OR 30 mg/m2/day to be confirmed at registration. IV 24 hour continuous infusion Days 1 and 8 every three weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lesley Seymour | 613-533-6430 | lseymour@ctg.queensu.ca |
| Canada, Alberta | |
| Tom Baker Cancer Centre | Recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Contact: Nizar Jacques Bahlis 403-944-1564 | |
| Cross Cancer Institute | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Irwindeep Sandhu 780-432-8757 | |
| Canada, New Brunswick | |
| Atlantic Health Sciences Corporation | Recruiting |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Contact: Anthony J. Reiman 506-648-6884 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Center | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Contact: Darrell White 902-473-7922 | |
| Canada, Ontario | |
| Juravinski Cancer Centre at Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Contact: Tom Kouroukis 905-387-9711 ext 62487 | |
| Univ. Health Network-Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Donna E. Reece 416-946-2994 | |
| Study Chair: | Tony Reiman | Atlantic Health Sciences Corporation, Saint John Regional Hospital |
More Information
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT01145989 History of Changes |
| Other Study ID Numbers: | I191 |
| Study First Received: | June 15, 2010 |
| Last Updated: | May 1, 2012 |
| Health Authority: | Canada: Health Canada |
|
Relapsed or Refractory Multiple Myeloma |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |