Study of ACY-1215 Alone and in Combination With Bortezomib and Dexamethasone in Multiple Myeloma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Acetylon Pharmaceuticals Incorporated.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Acetylon Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01323751
First received: February 25, 2011
Last updated: September 17, 2012
Last verified: September 2012

February 25, 2011
September 17, 2012
July 2011
December 2013   (final data collection date for primary outcome measure)
  • Phase 1 (a & b): To determine the maximum tolerated dose of ACY-1215 as monotherapy or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. [ Time Frame: Upon completion of 21-day treatment cycle ] [ Designated as safety issue: Yes ]
  • Phase 2a: To determine the objective response rate to ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. [ Time Frame: Assessed every other treatment cycle (cycles 2, 4 and 6) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01323751 on ClinicalTrials.gov Archive Site
  • Characterize the safety of ACY-1215 alone or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Determine the single- and multiple-dose PK of ACY-1215 alone and in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma [ Time Frame: Upon completion of 21 day treatment cycle ] [ Designated as safety issue: No ]
  • Evaluate the pharmacodynamics of ACY-1215 alone or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. [ Time Frame: Up to 24 weeks. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Study of ACY-1215 Alone and in Combination With Bortezomib and Dexamethasone in Multiple Myeloma
A Phase 1/2, Open-Label, Multicenter Study of ACY-1215 Administered Orally as Monotherapy and in Combination With Bortezomib and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma

Phase 1(a & b): To evaluate the side effects and determine the best dose of oral ACY-1215 as monotherapy, and also in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.

Phase 2a: To determine the objective response rate of oral ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: ACY-1215
Liquid oral dose on Days 1-5 and 8-12 of 21-day treatment cycle
Other Name: HDAC6 inhibitor
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has relapsed or relapsed/refractory MM with measurable disease parameters according to the International Myeloma Working Group (IMWG) Criteria

    • Refractory is defined as experiencing less than minimal response (MR) to or progressive disease (PD) within 60 days after completion of the most recent anti-MM regimen
    • Relapsed is defined as experiencing PD that requires therapy but which is not refractory following the achievement of stable disease (SD) or better to the most recent anti-MM regimen.
  • Patient received at least 2 prior regimens for MM.
  • Patient received prior treatment for MM with a proteasome inhibitor and an immunomodulatory drug, unless not a candidate for a proteasome inhibitor or an immunomodulatory drug.
  • Patient either is not a candidate for autologous stem cell transplant (ASCT), has declined the option of ASCT, or has relapsed after prior ASCT.
  • Patient is ≥18 years of age.
  • Patient has a Karnofsky Performance Status score of ≥70
  • Patient has adequate bone marrow reserve, as evidenced by:

    • Absolute neutrophil count (ANC) of ≥1.0x109/L.
    • Platelet count of ≥ 75x109/L in patients in whom <50% of bone marrow nucleated cells are plasma cells and ≥50x109/L in patients in whom more than 50% of bone marrow nucleated cells are plasma cells.
  • Patient has adequate renal function (calculated creatinine clearance of ≥30 mL/min according to the Cockroft-Gault)
  • Patient has adequate hepatic function (serum bilirubin values <2.0 mg/dL and ALT and/or AST values <3 × the upper limit of normal ULN).
  • Patient has a corrected serum calcium ≤ULN.

Exclusion Criteria

  • Patient has received any of the following therapies:

    • Radiotherapy or systemic therapy within 2 weeks of baseline
    • Prior peripheral autologous stem cell transplant within 12 wks of Baseline.
    • Prior allogeneic stem cell transplant.
    • Prior treatment with an HDAC inhibitor.
  • Patient has an active systemic infection requiring treatment.
  • Patient has a history of other malignancies unless has undergone definitive treatment more than 5 yrs prior to study and without evidence of recurrent malignant disease (excluding basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate-specific antigen <0.1 ng/mL; or cervical intraepithelial neoplasia).
  • Patient has known or suspected HIV, positive for hepatitis B or is known or suspected to have active hepatitis C infection.
  • Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness including recent myocardial infarction (within 6 months)or stroke; hypertension requiring >2 medications for adequate control; diabetes mellitus with >2 episodes of ketoacidosis in the preceding 12 months; or chronic obstructive pulmonary disease (COPD) requiring >2 hospitalizations in the preceding 12 months.
  • Patient has a QTcF value of >480 msec; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy; previous history of drug-induced QTc prolongation
  • Patient has > Grade 2 painful neuropathy or peripheral neuropathy
  • Patient has a history of allergic reaction attributable to bortezomib or other compounds containing boron or mannitol (Phase 1b and 2a only)
Both
18 Years and older
No
Contact: Gina Leone 617-245-1300 gleone@acetylon.com
United States
 
NCT01323751
ACY-100
Yes
Acetylon Pharmaceuticals Incorporated
Acetylon Pharmaceuticals Incorporated
The Leukemia and Lymphoma Society
Principal Investigator: Sagar Lonial, MD Winship Cancer Institute, Emory University
Acetylon Pharmaceuticals Incorporated
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP