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Oral ONC201 in Relapsed/Refractory Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Oncoceutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Oncoceutics, Inc.
ClinicalTrials.gov Identifier:
NCT02863991
First received: August 4, 2016
Last updated: March 20, 2017
Last verified: March 2017
  Purpose

ONC201 is an orally bioavailable first-in-class small molecule with demonstrated antitumor activity in preclinical models of difficult-to-treat solid and liquid tumors without imparting significant toxicity. This is a Phase 1/2 open-label study of ONC201 administered orally once every week in combination with dexamethasone to patients with relapsed/refractory multiple myeloma.

Funding Source - FDA OOPD


Condition Intervention Phase
Multiple Myeloma
Drug: ONC201
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Oral ONC201 in Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Oncoceutics, Inc.:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 3 years ]
    Best overall response


Estimated Enrollment: 42
Actual Study Start Date: January 1, 2016
Estimated Study Completion Date: March 8, 2020
Estimated Primary Completion Date: March 8, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ONC201
Single agent ONC201.
Drug: ONC201
ONC201

  Eligibility

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

Inclusion Criteria:

  1. Patients must be refractory to, or not a candidate for, established therapy known to provide clinical benefit for their malignancy.
  2. Measurable disease M protein component in serum (at least 0.5 g/dL) and/or urine (if present) (>=0.2 g excreted in a 24 hour collection sample).
  3. All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies discontinued for ≥ 14 days (≥ 28 days for mitomycin C or nitrosoureas) before study entry, and all acute effects of any prior therapy resolved to baseline severity or Grade ≤ 1 Common Terminology Criteria for Adverse Events (CTCAE v4.03), except alopecia or parameters defined in this eligibility list.
  4. Age ≥ 18 years.
  5. ECOG performance status ≤ 1.
  6. Adequate organ and marrow function as defined below:

    1. Absolute neutrophil count ≥1,000/mm3 without growth factor use ≤ 7 days prior to treatment (cycle 1 day 1, C1D1)
    2. Platelets ≥75,000/mm3 without platelet transfusion ≤ 3 days prior to C1D1
    3. Hemoglobin >8.0 mg/dL without red blood cell transfusion ≤ 3 days prior to C1D1
    4. Total serum bilirubin <1.5 X upper limit of normal (ULN)
    5. AST (SGOT)/ALT (SGPT) ≤2 X ULN; ≤ 5 X ULN if there is liver involvement secondary to tumor
    6. Serum creatinine ≤ 1.5 X ULN (OR creatinine clearance ≥ 60 mL/min/1.73 m2)
    7. Serum or urine pregnancy test (for females of childbearing potential) negative ≤7 days of starting treatment
  7. Ability to understand and the willingness to sign a written informed consent document and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
  8. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate.

Exclusion Criteria:

  1. Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
  2. Pregnancy or breast feeding.
  3. Current active treatment in another clinical study.
  4. Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV)
  5. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness that is not well controlled.
  6. Active or prior plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 10^9/L).
  7. Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
  8. Subjects with serum calcium (corrected for albumin) ≥ 12 mg/dL
  9. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
  10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02863991

Locations
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Henry Fung, MD    888-369-2427      
Sponsors and Collaborators
Oncoceutics, Inc.
  More Information

Responsible Party: Oncoceutics, Inc.
ClinicalTrials.gov Identifier: NCT02863991     History of Changes
Other Study ID Numbers: ONC007
R01FD005402 ( US NIH Grant/Contract Award Number )
Study First Received: August 4, 2016
Last Updated: March 20, 2017

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

ClinicalTrials.gov processed this record on March 24, 2017