Phase I Study for Safety and Efficacy of P276-00 in Subjects With Myeloma

NCT00547404 | Withdrawn Phase 1

• 1 other identifier: P276-00/11/07
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research study is a Phase I/II clinical trial. It is done to determine the best doses that the investigational drug (P276-00) can be used safely. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more information about it such as; the safest dose to use, the side effects it may cause and if it is effective for treating relapsed/refractory multiple myeloma. A majority of multiple myeloma patients overexpress a protein that plays a role in regulating the body's cell cycle called Cyclin D1. The study drug P276-00 is a Cyclin D1 inhibitor under investigation in the treatment of solid tumors. The researchers therefore believe that Cyclin D1 should be studied as a therapeutic target in myeloma. In this research study, we are looking for the highest dose of P276-00 that can be given safely and to see how well it works

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose (MTD) in subjects with relapsed and relapsed/refractory Multiple Myeloma (MM)

  1year

Secondary Outcomes (1)

• clinical response of P276-00 in subjects with relapsed and relapsed/refractory MM 2. Exploratory pharmacogenomic analysis of serum and molecular markers associated with P276-00 use in the study population

  1.5 years

Interventions

P276-00 DRUG

IV drug infusion over a period of 30 min on day 1,4,8 and 11 in21 day cycle for 6 cycles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subject previously diagnosed with multiple myeloma based either on the standard or the International Myeloma Foundation (IMF) diagnostic criteria as defined in Appendix A 2. Subjects must have relapsed or relapsed/refractory disease after at least 2 prior lines of therapy as defined in Appendix D 3. Monoclonal protein in the serum of ³ 1 gm/dL or monoclonal light chain in the urine protein electrophoresis of ³ 200 mg/ 24 hours, or measurable light chains by free light chain assay of ³ 10 mg/dL, or measurable plasmacytoma 4. Age ≥ 18 years at the time of signing the informed consent form 5. ECOG performance status \< 2 6. Life expectancy \> 3 months 7. Subjects must have the following laboratory parameters:
• Hemoglobin \> 8.0 gm/dL
• Absolute neutrophil count (ANC) ≥1000 cells/mm3
• Platelets count ≥ 50,000/mm3
• Serum SGOT/AST \<3.0 x institutional upper limits of normal (ULN)
• Serum SGPT/ALT \<3.0 x institutional upper limits of normal (ULN)
• Serum creatinine \<2.5mg/dL
• Serum total bilirubin \<1.5 x institutional upper limits of normal (ULN) 8. Woman of childbearing potential \[defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months) with a negative serum pregnancy test. In addition, all sexually active woman of childbearing potential and men agreeing to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised 9. Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• \. Subjects having received radiotherapy, immunotherapy, chemotherapy and or biological agents like G-CSF in the 2 weeks prior to day 1 of study drug administration and have not recovered completely from the side effects of the earlier investigational agent 2. Subjects having received any other investigational agents within 2 weeks prior to the date of enrolment 3. History of allergic reactions attributed to compounds of similar chemical composition to P276-00 4. Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months 5. Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years 6. Subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, known cardiac ejection fraction \<40%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 7. Women who are pregnant or nursing 8. Subjects known to be seropositive for the human immunodeficiency virus 9. Subjects requiring the use of concomitant medications that prolong the QT/QTc interval and/or are known to cause Torsades de Pointes (TdP) 10. Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study

Sponsors & Collaborators

• Piramal Enterprises Limited: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

P276-00

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Noopur Raje, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Sagar Lonial, MD

  Winship Cancer Institute,Emory University

  PRINCIPAL INVESTIGATOR

• Sundar Jagannath, MD

  St. Vincent's Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 22, 2007
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: April 23, 2009

Record last verified: 2009-04