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Active Clinical Trials

Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)

Active NCT:
03600441
West Penn Hospital
West Penn Hospital

Category:
Cancer - Blood
Sponsor: 
Xynomic Pharmaceuticals, Inc.
Contact: 

For more information, please contact Rich Wonder by telephone at 412-578-4492, or email at Rich.Wonder@ahn.org or Melissa McMillen, RN, MSN by telephone at 412-578-4493 or email at Melissa.McMillen@ahn.org.

XYN-601 (PIND: 136228): Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients with Relapsed or Refractory Follicular Lymphoma

Purpose: 

This study in patients with relapsed/refractory follicular lymphoma who have undergone at least 3 lines of therapy. Patients will receive abexinostat 80 mg (4 × 20 mg tablets) twice a day (BID) in a "one week on, one week off" schedule.

Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

Is able to understand and voluntarily sign an informed consent document before any study related assessments/procedures are conducted.

Has histologically confirmed Grade 1, 2, or 3a follicular lymphoma.

Has follicular lymphoma that has relapsed after (progressed after 6 months from the start of therapy) or is refractory to the last line of therapy (no response or progression within 6 months from the start of therapy) and needs treatment (must have at least 1 lymph node or extranodal lymphoid malignancy radiologically measuring ≥ 3 cm in its longest diameter).

Female patients must fulfil the following criteria:

a. Be of non-childbearing potential, defined as follows: i. Postmenopausal (ie, ≥ 1 year without any menses) prior to Screening, or ii. Documented surgically sterile (≥ 1 month prior to Screening)

Male patients must agree not to donate sperm starting from the time of Screening, throughout the study, and until after 90 days following the last dose.

Use highly effective forms of birth control (women of childbearing potential only), which include the following:

i. Consistent and correct use of established oral contraception ii. Established intrauterine device or intrauterine system iii. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

Female patients must agree not to breastfeed starting from the time of Screening, throughout the study, and until after 90 days following the last dose.

Male patients and their female spouse/partners who are of childbearing potential must use highly effective contraception methods consisting of 2 forms of birth control (at least 1 of which must be a barrier method) from the time of Screening, throughout the study, and until after 90 days following the last dose.

Male patients must agree not to donate sperm starting from the time of Screening, throughout the study, and until after 90 days following the last dose.

Exclusion Criteria:

Has diagnosis of Grade 3b follicular lymphoma, or transformation to diffuse large B-cell lymphoma

Has a history of central nervous system lymphoma (either primary or secondary).

Has had prior treatment with abexinostat.

Has had allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before enrollment

Has any types of cardiac impairment at the time of enrollment

Has received any investigational medication within 30 days or 5 half-lives prior to Day 1, whichever is longer

Has prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 3 years