BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors (NCT01957735) | Clinical Trial Compass
CompletedPhase 1
BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors
United States97 participantsStarted 2013-10
Plain-language summary
This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as monotherapy(treatment Arm 1) and in combination with chemotherapy (treatment Arm 2) in patients with solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* The patient has a histologically confirmed solid tumor that is metastatic or unresectable for which standard measures do not exist or are no longer effective. (Patients with primary brain cancer or lymphoma are permitted. Patients with brain metastases are allowed if whole brain radiation was performed and is documented stable for ≥ 6 weeks)
* The patient is at least 18 years old.
* The patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* The patient has a life expectancy of \> 3 months.
* Sexually active patients and their partners agree to use an accepted method of contraception during the course of the study
* Female patients of childbearing potential must have a negative pregnancy test within 1 week prior to beginning study treatment.
* The patient has adequate organ and marrow function as follows:
* ANC ≥ 1500 mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL,
* serum creatinine ≤1.8 mg/dL or creatinine clearance \> 50 mL/min (Appendix I);
* bilirubin ≤ 1.5 mg/dL; alanine aminotransferase (ALT), aspartate transaminase (AST) ≤ 2.5 times the upper limit of normal if no liver involvement or ≤ 5 times the upper limit of normal with liver involvement.
* The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed).
* The patient has adequate coagulation: prothrombin time (PT), partial thromboplastin time (…
What they're measuring
1
Determine Maximum Tolerated Dose (MTD) of BP31510
Timeframe: Wach week of treatment for the duration of Cycle 1 up to 4 weeks on Arm 1 and 6 weeks for Arm 2