Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma
This study has been completed.
Sponsor:
Callisto Pharmaceuticals
Information provided by:
Callisto Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00086216
First received: June 28, 2004
Last updated: December 20, 2007
Last verified: December 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Atiprimod |
Phase 1 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: | An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
U.S. FDA Resources
Further study details as provided by Callisto Pharmaceuticals:
Primary Outcome Measures:
- The primary objective of this study is to identify the maximum tolerated dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary objective of this study is to measure the pharmacokinetics of [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | May 2004 |
| Study Completion Date: | November 2007 |
Intervention Details:
Detailed Description:
-
Drug: Atiprimod
Oral, once a day, 14 days on 14 days off
This is a multi-center, open-label, dose escalation study intended to identify the MTD of atiprimod alone and the MTD of atiprimod when given in combination with ursodiol. The atiprimod dose will be escalated in sequential cohorts. Ten dose levels of atiprimod are planned for the atiprimod alone dose escalation: 30, 60, 90, 120, 180, 240, 300, 360, 420, and 480 mg/day to be given orally. Six dose levels of atiprimod are planned for the atiprimod in combination with ursodiol dose escalation: 180, 240, 300, 360, 420, and 480 mg/day to be given orally. The dose of ursodiol will remain constant for all cohorts (300 mg ursodiol orally three times a day everyday). Up to 105 patients will participate depending on the level at which toxicity is observed. Patients will be assigned to dose level in the order of study entry.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- documented history of multiple myeloma,
- failed at least two prior regimens for multiple myeloma,
- 18 years of age or older,
- ECOG(Zubrod)PS of 0 to 2,
- screening evaluation for determining eligibility prior to enrollment,
- signed informed consent form,
Exclusion Criteria:
- concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,
- renal insufficiency (serum creatinine levels of > 2mg/dL),
- mucosal bleeding,
- any condition which in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study.
- clinically relevant active infection or co-morbid medical conditions.
- prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years.
- patients with non-secretory myeloma.
- as atiprimod is a potent inhibitor or CYP2D6, patients taking drugs that are substrates of CYP2D6(e.g. beta blockers, antidepressants and antipsychotics) will be excluded.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086216
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086216
Locations
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Callisto Pharmaceuticals
Investigators
| Study Director: | Gary Jacob, PhD | Callisto Pharmaceuticals |
More Information
| Responsible Party: | Gary Jacob, Callisto Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00086216 History of Changes |
| Obsolete Identifiers: | NCT00301977, NCT00491972 |
| Other Study ID Numbers: | CP-101 efficacy pharmacokinetics research markers |
| Study First Received: | June 28, 2004 |
| Last Updated: | December 20, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Callisto Pharmaceuticals:
|
Multiple myeloma |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 23, 2016