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Study of Oral ONC201 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma

This study is currently recruiting participants.
Verified May 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02420795
First Posted: April 20, 2015
Last Update Posted: May 31, 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.
Collaborator:
Oncoceutics, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

This clinical research study will be done in two parts.

The goal of the first part is to find the highest tolerable dose of ONC201 that can be given to patients with relapsed or refractory MCL, DLBCL, and TLCL. Groups of subjects will receive increasing doses of ONC201 by mouth on day 1 of each 21 days cycle or on Day 1 of every week until there are side effects that are not tolerated or a maximum of 625 mg has been found to be tolerable.

As a result of new information, it has been decided that subjects in Arm A will continue receiving their dosing every 3 weeks. All other subjects will be dosed weekly. The dose you receive may be too low to have an effect or so high it causes bad side effects. In the second part of this study the highest dose of NC201 will be given to learn if ONC201 can help to control the disease. Please note that this is the first time ONC201 will be given to human subjects.


Condition Intervention Phase
Lymphoma Drug: ONC201 Behavioral: Phone Call Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Oral ONC201 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of ONC201 to Determine the Recommended Phase 2 Dose [ Time Frame: 21 days ]
    MTD defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT).


Secondary Outcome Measures:
  • Overall Response (OR) [ Time Frame: 21 days ]
    Overall response (OR) defined as either complete response (CR) or partial response (PR) observed in the first 3 treatment cycles. International Workshop Standardized Response Criteria for non-Hodgkin's Lymphoma used for measurable disease.


Estimated Enrollment: 60
Actual Study Start Date: November 3, 2015
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: ONC201 - Once every 3 Weeks
Phase I starting dose of ONC201 125 mg taken orally Day 1 of every 21-day cycle (enrollment in Arm A stopped February 2016). After end-of-dosing visit, study staff will call participant every 3 months for 1 year.
Drug: ONC201

Phase I starting dose of ONC201: 125 mg taken by mouth taken Day 1 of every 21-day cycle (Arm A, closed to new enrollment February 2016) or once weekly (Arm B).

Phase II starting dose: Maximum tolerated (MTD) dose from Phase I.

Behavioral: Phone Call
After end-of-dosing visit, study staff will call participant every 3 months for 1 year.
Other Name: Survey
Experimental: Arm B: ONC201 - Once a Week
Phase I starting dose of ONC201 125 mg taken orally Day 1 of every week. Dose escalation will continue until MTD is reached for recommended Phase 2 Dose. After end-of-dosing visit, study staff will call participant every 3 months for 1 year.
Drug: ONC201

Phase I starting dose of ONC201: 125 mg taken by mouth taken Day 1 of every 21-day cycle (Arm A, closed to new enrollment February 2016) or once weekly (Arm B).

Phase II starting dose: Maximum tolerated (MTD) dose from Phase I.

Behavioral: Phone Call
After end-of-dosing visit, study staff will call participant every 3 months for 1 year.
Other Name: Survey

  Show Detailed Description

  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

Inclusion Criteria:

  1. Phase 1 and Phase 2: Confirmed diagnosis of previously treated relapsed and/or refractory mantle cell lymphoma, diffuse large B-cell lymphoma. Patients with CNS lymphoma are included.
  2. Age >/= 18 years at the time of signing the informed consent.
  3. Patient with leukemia phase (peripheral blood involvement), CNS lymphoma [including cerebrospinal fluid (CSF)-only disease], non-measurable disease, gastrointestinal (GI) MCL, or bone marrow (BM) MCL are also eligible. Gastrointestinal or bone marrow or spleen only patients are allowable and will be analyzed separately.
  4. All adverse events related to prior therapies (chemotherapy, radiotherapy, and/or surgery) must be resolved to </= Grade 1, except for alopecia.
  5. Patients must be willing to receive transfusions of blood products.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  7. Patients must have the following clinical laboratory values: Serum creatinine < 2.0 mg/dl. ; Serum bilirubin < 1.5 mg/dl; Platelet count > 50,000/mm^3; Absolute neutrophil count (ANC) > 1,000/mm^3; Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) < 2 x upper limit of normal or < 5 x upper limit of normal if hepatic metastases are present.
  8. Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty.
  9. Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for 90 days after the last dose of study treatment. Acceptable methods of birth control include condoms with birth control foam, birth control pills, implantable or injectable birth control, birth control patch, intrauterine device (IUD), or diaphragm with spermicidal gel. Male patients must use an effective barrier method of contraception (i.e. , condoms with birth control foam or diaphragm with spermicidal gel) during the study and for 90 days following the last dose of study treatment if sexually active with a female of childbearing potential. Contraception must be in place at least 2 weeks prior to initiating study treatment.
  10. #9 cont. - * A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  11. Patient must be English-speaking [MD Anderson Symptom Inventory (MDASI) completion only]

Exclusion Criteria:

  1. Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk or would prevent the subject from signing the informed consent form.
  2. Pregnant or breast feeding females.
  3. Use of any standard/experimental anti-lymphoma drug therapy, including steroids (dexamethasone dose >/= 4 mg/day or prednisone >/= 20 mg/day), within 3 weeks of initiation of the study or use of any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of initiation of the study drug treatment. Hydroxyurea is permitted up to 24 hours before the first dose of study drug in patients with rapidly-proliferating disease.
  4. Prior allogeneic stem cell transplant (SCT) within 16 weeks or autologous SCT within 8 weeks of initiation of therapy. (Patients that require immunosuppressive therapy are not eligible within 60 days of therapy.)
  5. History of human immunodeficiency virus (HIV) infection. Patients with active Hepatitis B infection (not including patients with prior Hepatitis B vaccination; or positive serum Hepatitis B antibody). Hepatitis C infection is allowed as long as there is no active disease and is cleared by GI consultation. HIV screening is not required for this study.
  6. Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to enrollment.
  7. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or any other gastrointestinal condition that could interfere with the absorption and metabolism of ONC201
  8. Major surgery within 4 weeks of initiation of therapy.
  9. The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient's health and survival, than of the MCL, within the subsequent 6 months at the time of consent. Investigator discretion is allowed.
  10. Patients with New York Heart Association (NYHA) Class III and IV heart failure, myocardial infarction in the preceding 6 months, and significant conduction abnormalities, including but not limited to 2nd degree AV block type II, 3rd degree block, QT prolongation (QTc > 500 msec), sick sinus syndrome, ventricular tachycardia, symptomatic bradycardia (heart rate < 50 bpm), hypotension, light headedness and syncope. Patients with active atrial fibrillation will be excluded. The protocol excludes patients who have within the past year had a stent and by recommendation of their cardiologist need to stay on anticoagulants such as warfarin equivalent vitamin K antagonist.
  11. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ONC201 or its excipients.
  12. Acute infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to initiation of study.
  13. Active alcoholism or use of recreational drug (evaluated by history taking).
  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): NCT02420795


Contacts
Contact: Michael Wang, MD, MS 713-792-2860

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: MD Anderson Health Information Specialist    877-632-6789      
Sponsors and Collaborators
M.D. Anderson Cancer Center
Oncoceutics, Inc.
Investigators
Principal Investigator: Michael Wang, MD, MS M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02420795     History of Changes
Other Study ID Numbers: 2014-0630
NCI-2015-00706 ( Registry Identifier: NCI CTRP )
First Submitted: April 15, 2015
First Posted: April 20, 2015
Last Update Posted: May 31, 2017
Last Verified: May 2017

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

Keywords provided by M.D. Anderson Cancer Center:
Lymphoma
Non-Hodgkin's Lymphoma
Relapsed/Refractory
NHL
Mantle cell lymphoma
MCL
Diffuse large B-cell lymphoma
DLBCL
Transformed large cell lymphoma
TLCL
ONC201
Phone call

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases