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
NCT ID: NCT02051751
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2014-03-05
2016-08-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BYL719 and paclitaxel
All patients enrolled in the study will receive BYL719 once daily plus weekly paclitaxel
BYL719
BYL719 will be administered orally once daily on a continuous dosing schedule and dosed on a flat-fixed dose and not adjusted by body weight or body surface area, starting on Day 2 in the dose escalation part and Day 1 in the dose expansion part. In the dose escalation part, the BYL719 starting dose will be 300mg, with anticipated dose escalation to 350mg. In the dose expansion part, BYL719 will be administered at the recommended dose determined in the dose escalation part.
Paclitaxel
Paclitaxel will be administered once weekly at a dose of 80 mg/m2 i.v. (days 1, 8, 15 and 22) in a 28 day cycle in both dose escalation and expansion.
Interventions
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BYL719
BYL719 will be administered orally once daily on a continuous dosing schedule and dosed on a flat-fixed dose and not adjusted by body weight or body surface area, starting on Day 2 in the dose escalation part and Day 1 in the dose expansion part. In the dose escalation part, the BYL719 starting dose will be 300mg, with anticipated dose escalation to 350mg. In the dose expansion part, BYL719 will be administered at the recommended dose determined in the dose escalation part.
Paclitaxel
Paclitaxel will be administered once weekly at a dose of 80 mg/m2 i.v. (days 1, 8, 15 and 22) in a 28 day cycle in both dose escalation and expansion.
Eligibility Criteria
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Inclusion Criteria
2. \- has signed the Informed Consent Form (ICF)
3. \- has at least one measurable or non-measurable disease as per RECIST 1.1
4. \- has tumor tissue available for the analysis as described in the protocol
5. \- has adequate bone marrow and organ function as defined in the protocol
6. \- is able to swallow and retain oral medication for the dose escalation part, ALL above PLUS
7. \- 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.
8. \- 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:
* Patient is a Female with a histologically and/or cytologically confirmed diagnosis of breast cancer as detailed in the protocol and an ECOG performance status ≤ 1
Exclusion Criteria
2. \- has a known hypersensitivity to paclitaxel or other products containing Cremophor
3. \- has a contraindication to use the standard pre-treatment for paclitaxel
4. \- has a primary central nervous system (CNS) tumor or CNS tumor involvement as detailed in the protocol
5. \- has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
6. \- 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
7. \- has peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy or higher)
8. \- has undergone major surgery ≤ 4 weeks prior to starting study treatment or who has not recovered from side effects of such procedure
9. \- has a clinically significant cardiac disease or impaired cardiac function as detailed in the protocol
10. \- is currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment
11. \- has diabetes mellitus requiring insulin treatment and/or with clinical signs
12. \- has impaired gastrointestinal (GI) function or GI disease as described in the protocol
13. \- has a known positive serology for human immunodeficiency virus (HIV), active Hepatitis B, and/or active Hepatitis C infection
14. \- has any other condition that would, in the Investigator's judgment, preclude patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
15. \- is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzymes CYP3A or CYP2C8 as detailed in the protocol
16. \- is currently receiving treatment with agents that are metabolized solely by CYP3A and/or have a narrow therapeutic window
17. \- has a history of another malignancy within 2 years prior to starting study treatment, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix
18. \- Patient has a history of non-compliance to medical regimen or inability to grant consent
19. \- Pregnant or nursing (lactating) women
20. \- does not apply highly effective contraception during the study and through the duration as defined in the protocol
\- has received any prior cytotoxic therapy for the inoperable locally advanced (recurrent or progressive) or metastatic disease, or who had a progression/recurrent disease within 6 months after completion of an adjuvant/neoadjuvant therapy as described in the protocol
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
Horizon Oncology Center BioAdvance
Lafayette, Indiana, United States
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Barcelona, Catalonia, Spain
Countries
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References
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Rodon J, Curigliano G, Delord JP, Harb W, Azaro A, Han Y, Wilke C, Donnet V, Sellami D, Beck T. A Phase Ib, open-label, dose-finding study of alpelisib in combination with paclitaxel in patients with advanced solid tumors. Oncotarget. 2018 Aug 3;9(60):31709-31718. doi: 10.18632/oncotarget.25854. eCollection 2018 Aug 3.
Related Links
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Novartis results database
Other Identifiers
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CBYL719Z2101
Identifier Type: -
Identifier Source: org_study_id