A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatmen… (NCT02051751) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer
United States, France, Italy19 participantsStarted 2014-03-05
Plain-language summary
Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel combination
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. \- Adult \> or = 18 years old
✓. \- has signed the Informed Consent Form (ICF)
✓. \- has at least one measurable or non-measurable disease as per RECIST 1.1
✓. \- has tumor tissue available for the analysis as described in the protocol
✓. \- has adequate bone marrow and organ function as defined in the protocol
✓. \- is able to swallow and retain oral medication for the dose escalation part, ALL above PLUS
✓. \- has a histologically-confirmed, advanced unresectable solid tumors who have progressed on standard therapy (or not been able to tolerate) within three months before screening/baseline visit or for whom no standard anticancer therapy exists.
✓. \- has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 For dose expansion part, patient has ALL of above first six criteria PLUS either: 9- has a histologically/cytologically-confirmed HNSCC as detailed in the protocol and an ECOG performance status ≤ 1 or:
Exclusion criteria
✕. \- has received previous treatment with a PI3K or AKT inhibitor as described in the protocol
✕. \- has a known hypersensitivity to paclitaxel or other products containing Cremophor
✕. \- has a contraindication to use the standard pre-treatment for paclitaxel
What they're measuring
1
Dose escalation : Dose Limiting Toxicity (DLT)
Timeframe: Cycle 1 (28 days)
2
Dose expansion : Number of patients with adverse events as a measure of safety and tolerability
Timeframe: Screening, every 28 days until 30 days after last dose
. \- has a primary central nervous system (CNS) tumor or CNS tumor involvement as detailed in the protocol
✕. \- has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
✕. \- has received radiotherapy \> or = 4 weeks prior to starting study drugs, with exception of palliative radiotherapy, who has not recovered from side effects of such therapy to baseline or Grade ≤ 1 and/or from whom ≥ 30% of the bone marrow was irradiated
✕. \- has peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy or higher)
✕. \- has undergone major surgery ≤ 4 weeks prior to starting study treatment or who has not recovered from side effects of such procedure