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Phase I Open Label, Multi-center, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, a PI3K and HDAC Inhibitor, in Subjects With Refractory or Relapsed Lymphoma or Multiple Myeloma

Description

This is a Phase I, open-label, multi-center dose-escalation trial evaluating the safety and tolerability of CUDC-907 as a single agent administered orally, once daily, to patients with relapsed or refractory lymphoma or multiple myeloma. The following dosing schedules may be examined, all consisting of 21-day cycles and including: (i) continuous once daily (QD), (ii) twice weekly on Days 1, 4, 8, 11, 15, 18 (BIW) (iii) thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17, 19 (TIW) (iv) four days on/three days off on Days 1-4, 8-11, and 15-18 (4/3), and (v) five days on/two days off on Days 1-5, 8-12, and 15-19 (5/2) Sequential dose escalation cohorts of oral CUDC-907 are planned. Subject enrollment and dose escalation will proceed according to a standard 3+3 design. In the absence of DLT, each subject will be treated for a minimum of 21 days, and may continue to receive additional treatment until disease progression has been documented or other treatment discontinuation criteria have been met. MTD or BED expansion cohorts of up to 36 evaluable (e.g., up to 12 subjects in each of 2 or 3 specific tumor types or subtype) to better define the safety, tolerability and preliminary antitumor and pharmacodynamic activity of the study treatment, as well as suitability as an RP2D and schedule. Safety and tolerability will be assessed by the incidence and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.03). A Safety Review Committee (SRC) comprised of the Medical Monitor, Principal Investigators, and Sponsor representatives, will be convened to review safety information and to decide upon dose escalation and further subject enrollment. The antitumor activity of study treatment will be assessed according to standard response criteria as appropriate for each individual subject's tumor type (e.g., Revised Response Criteria for Malignant Lymphoma and the International Uniform Response Criteria for Multiple Myeloma). Exploratory biological markers of activity will be assessed in peripheral blood mononuclear cells (PBMC), plasma and tissue specimens (skin, tumor and bone marrow samples, where available).

Phase

Phase 1 - a new treatment that has not been tested, and researchers are looking for the best way to administer the treatment and how much can be given safely. Phase I trials are usually offered only to patients with advanced disease who would not be helped by other known treatments. Some patients are helped by these treatments, although in this early stage physicians don’t really know if the treatment will be effective.

Inclusion and Exclusion Criteria

  • Inclusion Criteria:
  • Subjects of ≥ 18 years of age with histopathologically confirmed diagnosis of lymphoma or multiple myeloma that is refractory to or relapsed after at least 2 prior regimens.
  • Measurable or evaluable disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments (excluding alopecia).
  • Absolute neutrophil count ≥ 1,000/µL; platelets ≥ 75,000/µL; creatinine ≤ 1.5x upper limit of normal (ULN); total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. For subjects with documented liver metastases, the AST/ALT may be ≤ 5x ULN.
  • Life expectancy of at least 3 months.
  • Women of child bearing potential must have a negative serum pregnancy test.
  • Men and women of child bearing potential must agree to use adequate birth control throughout their participation in the study and for 30 days following the last study treatment.
  • Able to provide written informed consent and to follow protocol requirements. Exclusion Criteria:
  • Systemic anticancer therapy within 3 weeks of study entry, except for nitrosoureas or mitomycin C (6 weeks).
  • Graft vs. host disease following prior allogeneic transplant within 3 months prior to study treatment.
  • Other investigational agents within 21 days prior to study treatment.
  • Pregnant or lactating/breast-feeding women.
  • Ongoing treatment with chronic immunosuppressants.
  • Active CNS lymphoma.
  • Known gastrointestinal condition that would interfere with swallowing or the oral absorption or tolerance of CUDC-907.
  • Ongoing diarrhea defined as more than 1 watery stools/day.
  • Serious infection requiring systemic antibiotic therapy within 14 days prior to study treatment.
  • Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis.
  • Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a subject and/or compliance with the protocol.
  • No second primary malignancy within 2 years of study entry other than adequately treated non-melanoma skin or superficial bladder cancer, curatively treated carcinoma in situ of the cervix or other curatively treated solid tumor deemed by the investigator to be at low risk for recurrence.
  • Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.

Sites

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