A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01285466
First received: January 26, 2011
Last updated: January 15, 2014
Last verified: January 2014

January 26, 2011
January 15, 2014
January 2011
May 2014   (final data collection date for primary outcome measure)
Incidence of Dose limiting toxicities during the first cycle of treatment. [ Time Frame: First treatment cycle (4 weeks) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01285466 on ClinicalTrials.gov Archive Site
  • Incidence of safety events during the whole treatment period (until progression of disease). [ Time Frame: From start of treatment until disease progression ] [ Designated as safety issue: Yes ]
  • pharmacokinetics of BEZ235, BKM120 and paclitaxel given in combination, on Day 1, 8 and 22. [ Time Frame: First treatment cycle (4 weeks) ] [ Designated as safety issue: No ]
  • Treatment efficacy (response to treatment according to RECIST criteria) [ Time Frame: From start of treatment until disease progression ] [ Designated as safety issue: No ]
  • Impact of treatment on biomarkers of Pi3 Kinase pathway (analyses of skin biopsies, circulating markers) [ Time Frame: From start of treatment until disease progression ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab
A Phase Ib Multi-center, Open-label, 4-arm Dose-escalation Study of Oral BEZ235 and BKM120 in Combination With Weekly Paclitaxel in Patients With Advanced Solid Tumors and Weekly Paclitaxel/Trastuzumab in Patients With HER2+ Metastatic Breast Cancer

The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic or Locally Advanced Solid Tumors,
  • Drug: BEZ235 + paclitaxel
  • Drug: BKM120 + paclitaxel
  • Drug: BEZ235 + paclitaxel + trastuzumab
  • Drug: BKM120 + paclitaxel + trastuzumab
  • Experimental: BEZ235 + paclitaxel
    Intervention: Drug: BEZ235 + paclitaxel
  • Experimental: BKM120 + paclitaxel
    Intervention: Drug: BKM120 + paclitaxel
  • Experimental: BEZ235 + paclitaxel + trastuzumab
    Intervention: Drug: BEZ235 + paclitaxel + trastuzumab
  • Experimental: BKM120 + paclitaxel + trastuzumab
    Intervention: Drug: BKM120 + paclitaxel + trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
110
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with metastatic or locally advanced solid tumors, for whom weekly paclitaxel treatment is indicated (BEZ235-paclitaxel /BKM120-paclitaxel treatment)
  • HER2+ metastatic or locally advanced breast cancer patients eligible for weekly paclitaxel and trastuzumab (BEZ235-paclitaxel-trastuzumab /BKM120-paclitaxel-trastuzumab treatment)
  • Adult patients (≥ 18 years) (males, females)
  • World Health Organization (WHO) performance status ≤ 2
  • Adequate bone marrow function:
  • Adequate hepatic and renal function:

Exclusion Criteria:

  • Patients with primary central nervous system (CNS) tumor or CNS tumor involvement. However, patients with a metastatic CNS lesion may participate in this trial, if the patient is > 4 weeks from therapy (including radiation and/or surgery) completion, clinically stable with respect to the tumor at the time of study entry, and not receiving enzyme-inducing antiepileptic drugs or corticosteroid therapy or taper, as treatment of the brain metastases
  • Patients who have received prior systemic anticancer therapy within the following time frames
  • Cyclical chemotherapy: ≤ 3 weeks before study treatment (6 weeks for patients treated with nitrosoureas)
  • Biological therapy: ≤ 4 weeks before study treatment, except treatment with trastuzumab (both parts of the trial)
  • Investigational drug: ≤ 4 weeks before study treatment
  • Patients who have undergone major surgery ≤ 4 weeks before study treatment
  • Patients receiving chronic treatment with corticosteroids or other immunosuppressive agents
  • Patients with uncontrolled, unmanageable, treatment-refractory diabetes mellitus
  • Active or history of major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicide attempt or ideation, or homicide, as judged by the investigator and/or based on recent psychiatric assessment

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Netherlands,   Spain,   Switzerland
 
NCT01285466
CBEZ235A2118, 2010-022331-11
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP