A First-in-Human Phase I Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0337 in Patients With Advanced Solid Tumors
G
Greg Durm, MD
Primary Investigator
Recruiting
18-100 years
All
Phase
N/A
2 Locations
Brief description of study
This is a Phase 1, open label, multi-center study of orally administered DSP-0337 in adult subjects with advance solid tumors that are refractory to standard treatment, or for whom no effective therapy exists.
Detailed description of study
The study is comprised of two parts: an initial dose escalation phase utilizing a 3 + 3 design to determine maximum tolerated dose followed by a dose expansion cohort in approximately 40 additional subjects. Study participants will initially receive DSP-0337 orally for 28 days (one cycle of treatment). If clinical benefit is seen, treatment can continue until disease progression.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Neoplasms,Advanced Solid Tumors
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria
Histologically or cytologically confirmed diagnosis of advanced cancer in patients with solid tumors that are refractory to standard treatment, or for whom no effective therapy exists
Organ function must be adequate
Exclusion Criteria
Has received systemic anti-cancer therapy within the 3 weeks prior to starting the trial
Has received radiotherapy within the 28 days prior to first dose or within 12 weeks for patients with glioblastoma, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control
Has received major surgery within the 4 weeks prior to starting the trial
Has significant inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
Clinically active known brain metastasis unless the brain metastases have been previously treated and are considered stable
Is pregnant or lactating
Had prior malignancy other than carcinoma in situ of the cervix or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 3 years previously with no subsequent evidence of recurrence
Has a known clinically significant GI disorder(s) including, but not limited to, inflammatory bowel disease or a history of extensive gastric resection and/or small intestinal resection
Has inability to take oral medications and/or has clinical or radiological diagnosis of bowel obstruction
Has had prior treatment with napabucasin
Additional Information:Histologically or cytologically confirmed diagnosis of advanced cancer in patients with solid tumors that are refractory to standard treatment, or for whom no effective therapy exists
Organ function must be adequate
Exclusion Criteria
Has received systemic anti-cancer therapy within the 3 weeks prior to starting the trial
Has received radiotherapy within the 28 days prior to first dose or within 12 weeks for patients with glioblastoma, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control
Has received major surgery within the 4 weeks prior to starting the trial
Has significant inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
Clinically active known brain metastasis unless the brain metastases have been previously treated and are considered stable
Is pregnant or lactating
Had prior malignancy other than carcinoma in situ of the cervix or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 3 years previously with no subsequent evidence of recurrence
Has a known clinically significant GI disorder(s) including, but not limited to, inflammatory bowel disease or a history of extensive gastric resection and/or small intestinal resection
Has inability to take oral medications and/or has clinical or radiological diagnosis of bowel obstruction
Has had prior treatment with napabucasin
Participants will not be paid for their participation.
Updated on
01 Aug 2024.
Study ID: 1802101819 (BBI-DSP0337-101)
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