An Investigational Drug, PD 0332991, Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00555906
First received: November 8, 2007
Last updated: June 4, 2013
Last verified: June 2013
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Purpose
This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in combination with Velcade and dexamethasone in patients who have received at least one previous treatment for multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Bortezomib Drug: Dexamethasone Drug: PD 0332991 |
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: | Phase 1/2 Open-Label Study Of The Safety And Efficacy Of PD 0332991 In Combination With Bortezomib And Dexamethasone In Patients With Refractory Multiple Myeloma |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Bortezomib
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Phase 2 - determine the objective response rate of PD 0332991 in combination with bortezomib and dexamethasone [ Time Frame: 1.5 yr ] [ Designated as safety issue: No ]
- Phase 1 - determine the maximum tolerated dose and recommended Phase 2 dose for PD 0332991 in combination with bortezomib and dexamethasone [ Time Frame: 2 yr ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Phase 1 - changes in the phosphorylation status of the Rb protein in myeloma cells [ Time Frame: 2 yr ] [ Designated as safety issue: No ]
- Phase 2 - determine the time to progression, progression-free survival, duration of response and overall survival of PD 0332991 in combination with bortezomib and dexamethasone [ Time Frame: 1.5 yr ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 53 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | August 2013 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Bortezomib
Escalating doses of bortezomib will be administered intravenously on Days 8, 11, 15 and 18 of a 28-day cycle (Schedule A) or of a 21-day cycle (Schedule B). The planned doses to be evaluated are 0.7, 1 and 1.3 mg/m2 in combination with PD 0332991 and dexamethasone.
Drug: Dexamethasone
20 mg, orally on Days 8, 11, 15 and 18 of a 28 day cycle (Schedule A) or of a 21-day cycle (Schedule B) in combination with PD 0332991 and bortezomib.
Drug: PD 0332991
Escalating doses of PD 0332991 will be administered orally on Days 1-21 of a 28-day cycle for Schedule A and on Days 1-12 of a 21-day cycle for Schedule B. The planned doses to be evaluated are 50, 75, 100 mg and 125 mg once daily in combination with bortezomib and dexamethasone.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of symptomatic multiple myeloma as defined by International Myeloma Working Group (IMWGURC).
- Phase 1: Relapsed or relapsed/refractory myeloma after at least 1 previous treatments and with a life expectancy of more than 3 months.
- Phase 2: Measurable (as defined by IMWGURC) disease after at least 1 previous treatment.
Exclusion Criteria:
- History of allogeneic stem cell transplant.
- Phase 2 only: Prior bortezomib therapy will only be allowed if there was a demonstrated positive response, and disease progression occurred off therapy.
- Must have not experienced significant blood level changes, e.g. very low platelets, while on previous bortezomib therapy
- Prior radiation therapy to > 25% of the bone marrow (whole pelvis is 25%).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555906
Locations
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Kansas City, Kansas, United States, 66160 | |
| Pfizer Investigational Site | |
| Westwood, Kansas, United States, 66205 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63110-1093 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Buffalo, New York, United States, 14263 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10021 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pfizer Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29425 | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Praha 2, Czech Republic, 12808 | |
| Germany | |
| Pfizer Investigational Site | |
| Heidelberg, Germany, 69120 | |
| Pfizer Investigational Site | |
| Mainz, Germany, 55131 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00555906 History of Changes |
| Other Study ID Numbers: | A5481004 |
| Study First Received: | November 8, 2007 |
| Last Updated: | June 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Bortezomib BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on June 18, 2013