BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients (NCT05291286) | Clinical Trial Compass
CompletedEarly Phase 1
BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients
United States21 participantsStarted 2022-10-17
Plain-language summary
This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral neuropathy (CIPN) thereby improving quality of life (QoL) in cancer patients who have been exposed to oxaliplatin and/or taxane-based chemotherapy. This study includes two randomized, placebo controlled, blinded treatment cycles of BXQ-350/placebo, an optional open-label BXQ-350 treatment period, and an unblinded Post-Treatment Follow-up period.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years of age at the time of signing the informed consent.
✓. Have a diagnosis of cancer.
✓. Have symptoms of CIPN persisting ≥6 months and determined by the participant's treating physician to be caused by prior exposure to oxaliplatin or taxane-based chemotherapy.
✓. Have an EORTC QLQ-CIPN20 score of 3 (quite a bit) or 4 (very much) on at least 1 of the 6 questions pertaining to numbness, tingling, or pain in the fingers/hands or toes/feet.
✓. Have a life expectancy \> 12 months.
✓. Have ECOG Performance Status of 0 or 1.
✓. Have acceptable liver function defined as:
✓. Have acceptable renal function defined as:
Exclusion criteria
✕. Have received chemotherapy known to cause CIPN in the last 12 months.
✕. Currently receiving or expected to initiate chemotherapy for the treatment of an active cancer during the study period; cancer therapies utilized to maintain remission that are not known to cause or exacerbate peripheral neuropathy, as well as maintenance endocrine/hormonal/immune therapy for cancer are allowed. Continuation of polyadenosine diphosphate-ribose polymerase (PARP) inhibitors or other targeted therapies not associated with peripheral neuropathy is permitted.
. Have a family history of a genetic/familial neuropathy.
✕. Have pre-existing clinical neuropathy ≥ Grade 2 per CTCAE v5.0 from any cause.
✕. Currently taking daily oral steroids exceeding prednisone 10 mg daily or its equivalent.
✕. Participants with brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no evidence of new or enlarging metastases and are off steroids for at least 7 days.
✕. Have had major surgery within 28 days prior to randomization or have not recovered from major side effects of the surgery if more than 4 weeks have elapsed since surgery. Minor outpatient procedures are allowed.