Study To Evaluate Safety and Efficacy of P276-00 in Subjects With Refractory Multiple Myeloma

• Sponsor: Piramal Enterprises Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00882063
• Collaborator: (none)
• Enrollment: 19
• Locations: 5
• Arm: 1
• Duration (Months): 52
• Patients Per Site: 3.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine safety of P276-00 in patients with advanced multiple myeloma and whether P276-00 is effective in the treatment of advanced cases of multiple myeloma.

Condition or Disease	Intervention/Treatment	Phase
Relapsed and/or Refractory Multiple Myeloma	Drug: P276-00	Phase 1/Phase 2

Detailed Description

This is an open label multicenter study of P276-00 in subjects with Relapsed and/or Relapsed/Refractory Multiple Myeloma. Cohort of 3 subjects will be enrolled at starting dose of P276-00 which is 50 mg/m2/day to be given intravenously from day 1 to day 5 every 21 days. This 21 day administration constitutes one cycle of P276-00. Six such cycles will be administered to the subjects. If the dose is well tolerated then next cohort will be enrolled at higher dose level of P276-00 till maximum tolerated dose is determined. Safety assessment will be repeated at regular interval and efficacy assessment will be repeated during every cycles.After the subject completes 6 cycles, there will be a follow-up visit after 4 weeks (+1 week) of study completion.Subjects who have stable disease or who have responded (MR, PR or CR) after completion of the 6 cycles will be given the option to continue treatment for a maximum of 12 cycles or until they are deemed to have progressive disease.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Multicenter Phase I/II Study To Evaluate Safety and Efficacy of P276-00 in Subjects With Relapsed and/or Relapsed/Refractory Multiple Myeloma
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: P276-00 Starting dose level of P276-00 is 50 mg/m2/day. The drug will be administered intravenously in 200 ml of 5% dextrose (D5W) over a period of 30 min. Subjects will be enrolled at different dose levels of P276-00 to determine maximum tolerated dose of P276-00.	Drug: P276-00; Subjects will be enrolled at different dose levels of P276-00 to determine maximum tolerated dose of P276-00.Starting dose level of P276-00 is 50 mg/m2/day to be administered intravenously in 200 ml of 5% dextrose (D5W) over a period of 30 min from day 1 to day 5 every 21 days. This constitutes one cycle of P276-00. Six such cycles will be administered to subjects.

Outcome Measures

Primary Outcome Measures

1. To determine the maximum tolerated dose of P276-00 in subjects with relapsed and/or relapsed/refractory Multiple Myeloma [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects previously diagnosed with multiple myeloma based either on the standard diagnostic criteria or the International Myeloma Foundation (IMF) diagnostic criteria as defined in Appendix A.

2. Subjects must have relapsed and/or relapsed/refractory disease after at least 2 prior lines of therapy as defined in Appendix D.

3. Monoclonal protein in the serum of > or = 1 g/dL or monoclonal light chain in the urine protein electrophoresis of > or = 200 mg/ 24 hours, or measurable light chains by free light chain assay of > or = 10 mg/dL, or measurable plasmacytoma.

4. Age > or = 18 years at the time of signing the informed consent form

5. ECOG performance status < or = 2

6. Life expectancy > or = 3 months

7. Subjects must have the following laboratory parameters:

• Hemoglobin > or = 8.0 gm/dL

• Absolute Neutrophil Count (ANC) > or = 1000 cells/mm3

• Platelets count > or = 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)

1. 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 women 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.

2. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Subjects having received radiotherapy, immunotherapy, chemotherapy and/or biological agents like G-CSF in the 4 weeks prior to day 1 of study drug administration or have not recovered (grade < or = 1) from adverse effects of such therapy received prior to 4 weeks

2. Subjects having received any other investigational agents within 4 weeks prior to the date of enrolment or have not recovered from adverse effects of the investigational agent received prior to 4 weeks.

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, 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 or any history or evidence from physical examination of HIV infection.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jaslok Hospital & Research Centre	Mumbai	Maharashtra	India	400 026
2	Shatabdi Superspeciality Hospital	Nasik	Maharashtra	India	422002
3	Netaji Subhash Chandra Bose Cancer Research Institute	Kolkata	West Bengal	India	700016
4	Rajiv Gandhi Cancer Institute And Research Centre	Delhi		India	110085
5	Institute Rotary Cancer Hospital,All India Institute Of Medical Sciences(AIIMS)	New Delhi		India	110029

Sponsors and Collaborators

• Piramal Enterprises Limited

Investigators

• Study Director: Himanshu Parikh, M.D., Vice President- Clinical Research (R & D), Nicholas Piramal Research Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Piramal Enterprises Limited
• ClinicalTrials.gov Identifier: NCT00882063
• Other Study ID Numbers: P276-00/15/07
• First Posted: Apr 16, 2009
• Last Update Posted: Nov 21, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Piramal Enterprises Limited: Multiple Myeloma
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Nov 21, 2012