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A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03288480
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Phosplatin Therapeutics

Tracking Information
First Submitted Date  ICMJE September 11, 2017
First Posted Date  ICMJE September 20, 2017
Last Update Posted Date September 5, 2019
Actual Study Start Date  ICMJE December 15, 2017
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
Recommended dose (RD) of PT-112 for further studies in patients with relapsed or refractory multiple myeloma (MM) [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03288480 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • Peak Plasma Concentration (Cmax) [ Time Frame: 18 months ]
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: 18 months ]
  • Dose-limiting toxicities (DLTs) [ Time Frame: 18 months ]
  • Number of patients with Adverse Events (AEs) [ Time Frame: 18 months ]
    Characterization of the type, incidence, severity, duration, reversibility and relationship to treatment of adverse events (AEs), and effects on vital signs and laboratory parameters.
  • Tumor response, including assessment of minimal residual disease, according to the International Myeloma Working Group (IMWG) response criteria [ Time Frame: 18 months ]
  • Duration of response [ Time Frame: 18 months ]
  • Progression free survival [ Time Frame: 18 months ]
  • Relationship between sensitivity/response to treatment and disease status including cytogenetic biomarkers [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma
Official Title  ICMJE A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma
Brief Summary

Study PT-112-102, a multicenter, open-label dose-finding and pharmacokinetic study of PT-112 in patients with relapsed or refractory multiple myeloma.

This is designed as a two-part study. In the first part of the study, cohorts of three patients (expanded to six patients in the event of a dose-limiting toxicity) will receive escalating doses of PT-112 until the MTD is reached, based on tolerability observed during the first 28 days of treatment. In the second part of the study, an expansion cohort of 14 patients will be treated at the recommended dose to confirm the tolerability of treatment and evaluate evidence of treatment efficacy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:

This is a multicenter, open-label study of PT-112 in patients with relapsed or refractory MM. The study will be conducted in two parts:

Part 1: Dose escalation Part 2: Dose expansion

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Drug: PT-112
This is a single arm study
Study Arms  ICMJE PT-112
This is a single arm study of PT-112, which is administered to patients with relapsed or refractory MM
Intervention: Drug: PT-112
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2017)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Previously diagnosed with MM requiring treatment based on IMWG diagnostic criteria;
  2. Relapsed or refractory MM after adequate exposure to and therapeutic response (following IMWG response criteria) to at least one line of treatment with one or more active agents, including alkylating drugs, corticosteroids, immunomodulatory drugs (IMiD: thalidomide, lenalidomide, pomalidomide), proteasome inhibitors (bortezomib, cartilzomib), and monoclonal antibodies (daratumumab, elotuzumab, ixazomab);
  3. Evaluable MM with at least one of the following: (a) serum monoclonal component ≥ 0.5 g/dL; or (b) Bence Jones (BJ) proteinuria ≥ 200 mg/24h; or (c) measurable plasmacytoma (not previously irradiated); or (d) involved serum free light chain ≥ 10 mg/dL with an abnormal free light chain ratio;
  4. ECOG Performance Status (PS) 0-2;
  5. Life expectancy > 3 months;
  6. At least 2 weeks (or 5 half-lives, whichever is longer) wash-out since the end of previously administered experimental therapy (6 weeks if previous nitrosourea containing regimen) or 2 weeks for standard-of-care regimens. Concurrent corticosteroids are allowed provided they are administered at an equivalent prednisone dose of ≤ 10 mg/day, as prediction or blood products only;
  7. Recovery from non-hematologic toxic effects of prior therapy to grade ≤ 1 (except alopecia) by NCI CTCAE Version 4.03;
  8. Adequate bone marrow (BM), renal, hepatic and metabolic function.

Key Exclusion Criteria:

  1. Any of the following concomitant diseases/conditions:

    • History or presence of myocardial infarction, clinically relevant valvular heart disease, or congestive heart failure within the last 12 months;
    • Unstable cardiac dysrhythmias or persistent prolongation of the corrected QT interval (QTc) (Fridericia) to >480 msec for males or >500 msec for females, based on ECG at screening (patients with stable atrial fibrillation on treatment are allowed provided they do not meet any other cardiac or prohibited drug exclusion criterion);
    • Presence of current angina;
    • Active uncontrolled infection;
    • Morphological or cytological features of myelodysplasia and/or post-chemotherapy aplasia on BM assessment;
    • Myopathy > grade 2 or any clinical situation that causes significant and persistent elevation of CPK (>2.5 x ULN in two different determinations performed one week apart);
    • Peripheral neuropathy > grade 1, except for grade 2 without limitations on instrumental daily life activities;
    • POEMS syndrome or active plasma cell leukemia;
    • Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD;
    • History or presence within the last 3 months of Deep Vein Thrombosis (DVT) or a pulmonary embolism (PE);- Uncontrolled leptomeningeal disease;
    • Uncontrolled disease-related metabolic disorder (e.g., hypercalcemia);
    • Acute or chronic infections requiring systemic therapy, including, among others:
    • active infection requiring systemic therapy;
    • history of testing positive to human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome;
    • hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive);
    • active tuberculosis (history of exposure or history of positive TB test with presence of clinical symptoms, physical or radiographic finding);
    • Any other major illness that, in the Investigator's judgment, may substantially increase the risk associated with the patient's participation in this study;
  2. History of prior malignancy other than those previously treated with a curative intent more than 5 years ago and without relapse (any tumor) or basal cell skin cancer, in situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps treated adequately, regardless of the disease-free interval;
  3. Prior irradiation to > 30% of BM reserves (including total body irradiation), regardless of the washout period;
  4. High dose chemotherapy followed by autologous stem cell transplantation within 90 days prior to initiating study treatment;
  5. Bisphosphonate treatment within 7 days prior to initiating study treatment (while on study, bisphosphonates can be administered only once a month, between Days 18 to 21 of the 28-day treatment cycle)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tammy Hood 919.792.3740 thood@medsource.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03288480
Other Study ID Numbers  ICMJE PT-112-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Phosplatin Therapeutics
Study Sponsor  ICMJE Phosplatin Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leif Bergsagel, MD Mayo Clinic
PRS Account Phosplatin Therapeutics
Verification Date November 2018

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