NCT00882063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 21, 2012

Status Verified

November 1, 2012

Enrollment Period

1.8 years

First QC Date

April 15, 2009

Last Update Submit

November 20, 2012

Conditions

Relapsed and/or Refractory Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose of P276-00 in subjects with relapsed and/or relapsed/refractory Multiple Myeloma

    18 months

Study Arms (1)

P276-00

EXPERIMENTAL

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

Interventions

P276-00DRUG

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.

P276-00

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Subjects must have relapsed and/or relapsed/refractory disease after at least 2 prior lines of therapy as defined in Appendix D.
  • 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.
  • Age \> or = 18 years at the time of signing the informed consent form
  • ECOG performance status \< or = 2
  • Life expectancy \> or = 3 months
  • 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)
  • 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.
  • +1 more criteria

You may not qualify if:

  • 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
  • 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.
  • History of allergic reactions attributed to compounds of similar chemical composition to P276-00.
  • Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months.
  • 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.
  • 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
  • Women who are pregnant or nursing
  • Subjects known to be seropositive for the human immunodeficiency virus or any history or evidence from physical examination of HIV infection.
  • Subjects requiring the use of concomitant medications that prolong the QT/QTc interval and/or are known to cause Torsades de Pointes (TdP).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Jaslok Hospital & Research Centre

Mumbai, Maharashtra, 400 026, India

Location

Shatabdi Superspeciality Hospital

Nashik, Maharashtra, 422002, India

Location

Rajiv Gandhi Cancer Institute And Research Centre

Delhi, National Capital Territory of Delhi, 110085, India

Location

Institute Rotary Cancer Hospital,All India Institute Of Medical Sciences(AIIMS)

New Delhi, New Delhi, 110029, India

Location

Netaji Subhash Chandra Bose Cancer Research Institute

Kolkata, West Bengal, 700016, India

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

P276-00

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Himanshu Parikh, M.D.

    Vice President- Clinical Research (R & D), Nicholas Piramal Research Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2009

First Posted

April 16, 2009

Study Start

January 1, 2008

Primary Completion

November 1, 2009

Study Completion

May 1, 2012

Last Updated

November 21, 2012

Record last verified: 2012-11

Locations

IN(5)