Safety Study of ON 013105 in Lymphoma and Acute Lymphoid Leukemia

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, dose-escalation Phase 1 study of the investigational agent, ON 013105. In laboratory animal studies, ON 013105 has demonstrated anti-cancer activity. The purpose of this study is to determine the highest dose of ON 013105 that can be given safely in patients with relapsed/refractory Lymphoma or B-cell Acute Lymphocytic Leukemia (Philadelphia chromosome negative). Patients will receive weekly 2-hour IV infusions of ON 013105 at higher and higher doses until intolerable side effects are observed. It is important to know the highest safe dose so additional studies can be done.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Onconova Therapeutics, Inc.

Criteria

Inclusion Criteria:

• ≥ 18 years of age

• Documented (cytologically confirmed) relapsed/ refractory Lymphoma or B-cell Acute Lymphocytic Leukemia (Philadelphia chromosome negative)

• ECOG Performance Status score of 0, 1, or 2 (see Attachment 1)

• Expected survival, in the opinion of the Investigator, of at least 3 months, to allow a sufficient observation period for evaluation of ON 013105

• Recovery to at least grade I from adverse effects of prior therapies

• Adequate contraceptive [including prescription oral contraceptives (birth control pills), contraceptive injections, intrauterine device (IUD), double-barrier method (spermicidal jelly or foam with condoms or diaphragm), contraceptive patch, or surgical sterilization] before entry and throughout the study for female patients of reproductive potential

• Female patient with reproductive potential must have a negative serum beta-HCG pregnancy test at screening

• Willing to adhere to the prohibitions and restrictions specified in this protocol

• Patient (or his/her legally authorized representative) must have signed an informed consent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study

Exclusion Criteria:

• Grade 3 thrombocytopenia (platelets <50,000/µL) or neutropenia (ANC <1000/µL) ) except if documented evidence of bone marrow involvement of lymphoma or leukemia contributing to cytopenias.

• Any active malignancy within the past year except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast

• History of HIV-1 seropositivity

• Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia

• Active infection not adequately responding to appropriate therapy.

• Total bilirubin > 1.5 mg/dL not related to hemolysis or Gilbert's disease, AST/ALT > 1.5 X ULN

• Serum creatinine > 1.5 mg/dL or calculated creatinine clearance < 60 ml/min.

• Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <130 Meq/L).

• Women patients who are pregnant or lactating

• Male patients with female sexual partners who are unwilling to follow the strict contraception requirements described in this protocol (see Section 4.4).

• Major surgery without full recovery or major surgery within 3 weeks of ON 013105 treatment start.

• Uncontrolled hypertension (defined as a systolic pressure ³ 180 and/or a diastolic pressure ³ 110)

• New onset seizures (within 3 months prior to the first dose of ON 013105) or poorly controlled seizures

• Any concurrent investigational agent or chemotherapy, radiotherapy or immunotherapy

• Psychiatric illness/social situations that would limit the patient's ability to tolerate and/or comply with study requirements