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
Conditions
Neoplasms, Breast Neoplasms, Head and Neck Neoplasms
Conditions: official terms
Breast Neoplasms - Head and Neck Neoplasms
Conditions: Keywords
Solid tumors, Head and neck non squamous cell carcinoma, breast cancer, PI3K inhibitor, BYL719, paclitaxel
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: BYL719 Type: Drug
Name: Paclitaxel Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion criteria For entire trial:

1. - Adult > or = 18 years old

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

Common exclusion criteria to Dose escalation and Dose expansion parts:

1. - has received previous treatment with a PI3K or AKT inhibitor as described in the protocol

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

For the HNSCC patient's cohort additional exclusion criteria are:

21- Treatment with more than one prior chemotherapy for recurrent/metastatic disease as detailed in the protocol 22- Prior taxane treatment for metastatic disease additional exclusion criteria for breast cancer patients' cohort:

- 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

Other protocol-defined inclusion/exclusion criteria may apply
Locations
Highlands Oncology Group
Fayetteville, Arkansas, United States
Status: Recruiting
Contact: Lori Drummond - 479-587-1700 - ldrummond@hogonc.com
Horizon Oncology Center BioAdvance
Lafayette, Indiana, United States
Status: Recruiting
Contact: Julia Keenoy - 765-446-5165 - jkeenoy@horizonbioadvance.com
Novartis Investigative Site
Woodville, South Australia, Australia
Status: Not yet recruiting
Novartis Investigative Site
Heidelberg, Victoria, Australia
Status: Not yet recruiting
Novartis Investigative Site
Paris, France
Status: Not yet recruiting
Novartis Investigative Site
Toulouse Cedex 9, France
Status: Recruiting
Novartis Investigative Site
Cuneo, CN, Italy
Status: Not yet recruiting
Novartis Investigative Site
Milano, MI, Italy
Status: Not yet recruiting
Novartis Investigative Site
Milano, MI, Italy
Status: Recruiting
Novartis Investigative Site
Sondrio, SO, Italy
Status: Not yet recruiting
Novartis Investigative Site
Verona, VR, Italy
Status: Not yet recruiting
Novartis Investigative Site
Sevilla, Andalucia, Spain
Status: Withdrawn
Novartis Investigative Site
Barcelona, Catalunya, Spain
Status: Recruiting
Novartis Investigative Site
Barcelona, Catalunya, Spain
Status: Not yet recruiting
Novartis Investigative Site
Madrid, Spain
Status: Not yet recruiting
Novartis Investigative Site
Aarau, Aargau, Switzerland
Status: Not yet recruiting
Novartis Investigative Site
Zürich, Switzerland
Status: Not yet recruiting
Start Date
March 2014
Completion Date
March 2016
Sponsors
Novartis Pharmaceuticals
Source
Novartis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page