Study of Paclitaxel in Combination With BOS172722 in Patients With Advanced Nonhaematologic Malig… (NCT03328494) | Clinical Trial Compass
CompletedPhase 1
Study of Paclitaxel in Combination With BOS172722 in Patients With Advanced Nonhaematologic Malignancies
United Kingdom38 participantsStarted 2017-10-13
Plain-language summary
This study will be conducted to assess the safety and tolerability of BOS172722 when administered as monotherapy and in combination with paclitaxel in participants with advanced nonhaematologic malignancies and also to establish the maximum tolerated dose and recommended Phase 2 dose of BOS172722 in combination with paclitaxel in those participants.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
* For Part A only, histopathologically confirmed diagnosis of an advanced nonhaematologic malignancy
* For Part B only, histopathologically confirmed diagnosis of triple-negative breast cancer
* No standard curative treatment or has declined standard therapy
* Eastern Cooperative Oncology Group performance status 0 or 1, measured within 72 hours before the first BOS172722 or paclitaxel dose
* Predicted life expectancy of ≥ 3 months
* Adequate renal function (creatinine ≤ 1.5 × upper limit of normal \[ULN\] or glomerular filtration rate ≥ 50 milliliters per minute \[mL/min\])
* Adequate hepatic function:
* Total bilirubin ≤ 1.5 × ULN
* Aspartate transaminase ≤ 3 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor)
* Alanine transaminase ≤ 3 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor)
* Adequate bone marrow function:
* Hemoglobin ≥ 9.0 grams per deciliter (g/dL)
* Platelet count ≥ 100 × 10\^9 cells per liter (cells/L)
* Absolute neutrophil count ≥ 1.5 × 10\^9 cells/L
* Mean corrected QT interval as calculated by the Fridericia correction formula \< 470 milliseconds
* Willingness to use adequate contraceptive methods
* Capable of giving signed informed consent
* Willingness to avoid direct sunlight and the use of tanning equipment during the study and for at least 30 days after the last BOS172722 dose
Exclusion Criteria:
Part…
What they're measuring
1
Incidence of adverse events (AEs)
Timeframe: a minimum of approximately 3 months
2
Number of participants with a dose-limiting toxicity (DLT)