We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    PT-112

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

This study is not yet open for participant recruitment.
Verified November 2017 by Phosplatin Therapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT03288480
First Posted: September 20, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Phosplatin Therapeutics
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma Drug: PT-112 Phase 1

Study Type: Interventional
Study Design: 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
Official Title: A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Phosplatin Therapeutics:

Primary Outcome Measures:
  • Recommended dose (RD) of PT-112 for further studies in patients with relapsed or refractory multiple myeloma (MM) [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 34
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: May 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PT-112
This is a single arm study of PT-112, which is administered to patients with relapsed or refractory MM
Drug: PT-112
This is a single arm study

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 1 g/dL IgG or ≥ 0.5 g/dL IgA; 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 >450 msec for males or >470 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;
    • POEMS syndrome or active plasma cell leukemia;
    • Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD;
    • Uncontrolled leptomeningeal disease;
    • Uncontrolled disease-related metabolic disorder (e.g., hypercalcemia);
    • Known human immunodeficiency virus (HIV) infection (HIV testing is not required unless infection is clinically suspected);
    • Known active hepatitis B or C virus (HBV or HCV) infection;
    • Limitation of the patient's ability to comply with treatment or follow-up requirements; and
    • 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288480


Contacts
Contact: Robert Yates 850-483-1440 ryates@medsource.com

Locations
United States, Arizona
Mayo Clinic Cancer Center Not yet recruiting
Phoenix, Arizona, United States, 85054
Contact: Clinical Trials Office    855-776-0015      
Principal Investigator: Leif Bergsagel, MD         
United States, Florida
Mayo Clinic Cancer Center Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Office    855-776-0015      
Principal Investigator: Sikander Ailawadhi, MD         
United States, Minnesota
Mayo Clinic Cancer Center Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office    855-776-0015      
Principal Investigator: Taxiarchis Kourelis, MD         
United States, New Jersey
Rutgers Cancer Institute of New Jersey Not yet recruiting
New Brunswick, New Jersey, United States, 08903
Contact: General Information    732-235-2465      
Principal Investigator: Dennis Cooper, MD         
Sponsors and Collaborators
Phosplatin Therapeutics
Investigators
Principal Investigator: Leif Bergsagel, MD Mayo Clinic
  More Information

Responsible Party: Phosplatin Therapeutics
ClinicalTrials.gov Identifier: NCT03288480     History of Changes
Other Study ID Numbers: PT-112-102
First Submitted: September 11, 2017
First Posted: September 20, 2017
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases