Clinical trial · Interventional
Safety Study of ON 013105 in Lymphoma and Acute Lymphoid Leukemia
Phase 1, Dose Escalation Study To Assess the Safety, Pharmacokinetics and Activity of 2-Hour Continuous Intravenous Dosing of ON 013105 Administered Weekly in Patients With Relapsed/Refractory Lymphoma and Acute Lymphoid Leukemia
NCT01049113CI-TRIAL-00020116terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of available clinical drug supply
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ON 013105 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ON 013105
- description
- ON 013105 administered intravenously as 2-hour infusion once a week for 3 weeks of 3-week cycles. This is dose escalation study; starting dose is 17 mg.
- interventionNames
- Drug: ON 013105
Primary outcomes (1)
- measure
- Safety based on adverse events, hematology and chemical laboratory values, urinalysis, coagulation, ECG, vital signs, physical examination.
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- Tumor response (according to Cheson, B.D., et al., Revised Response Criteria for Malignant Lymphoma, J Clin Oncol 2007. 25: p. 579-86).
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDPark IW, Reddy MV, Reddy EP, Groopman JE. Evaluation of novel cell cycle inhibitors in mantle cell lymphoma. Oncogene. 2007 Aug 16;26(38):5635-42. doi: 10.1038/sj.onc.1210350. Epub 2007 Mar 19. PMID 17369860
- BACKGROUNDPrasad A, Park IW, Allen H, Zhang X, Reddy MV, Boominathan R, Reddy EP, Groopman JE. Styryl sulfonyl compounds inhibit translation of cyclin D1 in mantle cell lymphoma cells. Oncogene. 2009 Mar 26;28(12):1518-28. doi: 10.1038/onc.2008.502. Epub 2009 Feb 9. PMID 19198627