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. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00555906

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 I Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Bortezomib PD 0332991

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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: Yes ]
Phase 1 - determine the maximum tolerated dose and recommended Phase 2 dose for PD 0332991 in combination with bortezomib and dexamethasone [ Time Frame: 9 mo ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Phase 1 - changes in the phosphorylation status of the Rb protein in myeloma cells [ Time Frame: 9 mo ] [ 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:	62
Study Start Date:	January 2008
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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 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 100 mg and 125 mg once daily in combination with bortezomib and dexamethasone.

Arms

Assigned Interventions

1: Experimental

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 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 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 2 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 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

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, Illinois
Pfizer Investigational Site	Recruiting
Chicago, Illinois, United States, 60611
United States, New York
Pfizer Investigational Site	Recruiting
New York, New York, United States, 10021
United States, Pennsylvania
Pfizer Investigational Site	Not yet recruiting
Pittsburgh, Pennsylvania, United States, 51232

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5481004
Study First Received:	November 8, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00555906
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dexamethasone
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Enzyme Inhibitors

Hormones
Glucocorticoids
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009