Metastatic or Locally Advanced Solid TumorsPhase 1NCT01285466
A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab
A Phase 1 study testing BEZ235 + paclitaxel, BKM120 + paclitaxel and BEZ235 + paclitaxel + trastuzumab in people with Metastatic or Locally Advanced Solid Tumors, run by Novartis Pharmaceuticals at 10 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic or Locally Advanced Solid Tumors
- What is being tested?
- BEZ235 + paclitaxel, BKM120 + paclitaxel and BEZ235 + paclitaxel + trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 10 sitesin 5 countries
- Study dates
- Jan 2011to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Belgium3 sites
Novartis Investigative Site
Brussels, 1000
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Wilrijk, 2610
Germany2 sites
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Essen, 45147
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Seville, Andalusia, 41013
Switzerland2 sites
Novartis Investigative Site
Chur, 7000
Novartis Investigative Site
Sankt Gallen, 9007
About this study
Official title: 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.
- Being tested
- BEZ235 + paclitaxel, BKM120 + paclitaxel, BEZ235 + paclitaxel + trastuzumab, BKM120 + paclitaxel + trastuzumab
- Keywords
- Cancer, BEZ235, BKM120, paclitaxel, trastuzumab
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEZ235 + paclitaxelDrug
BKM120 + paclitaxelDrug
BEZ235 + paclitaxel + trastuzumabDrug
BKM120 + paclitaxel + trastuzumabDrug
| Study group | Role | What they receive |
|---|---|---|
| BEZ235 + paclitaxel | Experimental | Not described Receives: Drug: BEZ235 + paclitaxel |
| BKM120 + paclitaxel | Experimental | Not described Receives: Drug: BKM120 + paclitaxel |
| BEZ235 + paclitaxel + trastuzumab | Experimental | Not described Receives: Drug: BEZ235 + paclitaxel + trastuzumab |
| BKM120 + paclitaxel + trastuzumab | Experimental | Not described Receives: Drug: BKM120 + paclitaxel + trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose limiting toxicities during the first cycle of treatment.
Measured: First treatment cycle (4 weeks)
Secondary outcomes (4)
Incidence of safety events during the whole treatment period (until progression of disease).
Measured: From start of treatment until disease progression
pharmacokinetics of BEZ235, BKM120 and paclitaxel given in combination, on Day 1, 8 and 22.
Measured: First treatment cycle (4 weeks)
Treatment efficacy (response to treatment according to RECIST criteria)
Measured: From start of treatment until disease progression
Impact of treatment on biomarkers of Pi3 Kinase pathway (analyses of skin biopsies, circulating markers)
Measured: From start of treatment until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic or Locally Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285466
- Sponsor's protocol ID
- CBEZ235A2118
- Other IDs
- 2010-022331-11
- Status last verified
- Feb 2017
- First submitted
- 26 Jan 2011
- Last updated
- 9 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01285466
- Acronym / sponsor ID
- CBEZ235A2118
- Keywords
- Cancer, BEZ235, BKM120, paclitaxel, trastuzumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BEZ235 + paclitaxel | Experimental | Drug: BEZ235 + paclitaxel |
| BKM120 + paclitaxel | Experimental | Drug: BKM120 + paclitaxel |
| BEZ235 + paclitaxel + trastuzumab | Experimental | Drug: BEZ235 + paclitaxel + trastuzumab |
| BKM120 + paclitaxel + trastuzumab | Experimental | Drug: BKM120 + paclitaxel + trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEZ235 + paclitaxel | Drug | BEZ235 + paclitaxel |
| BKM120 + paclitaxel | Drug | BKM120 + paclitaxel |
| BEZ235 + paclitaxel + trastuzumab | Drug | BEZ235 + paclitaxel + trastuzumab |
| BKM120 + paclitaxel + trastuzumab | Drug | BKM120 + paclitaxel + trastuzumab |
Primary outcome
Incidence of Dose limiting toxicities during the first cycle of treatment.
Time frame: First treatment cycle (4 weeks)
4 secondary outcomes
Incidence of safety events during the whole treatment period (until progression of disease).
Time frame: From start of treatment until disease progression
pharmacokinetics of BEZ235, BKM120 and paclitaxel given in combination, on Day 1, 8 and 22.
Time frame: First treatment cycle (4 weeks)
Treatment efficacy (response to treatment according to RECIST criteria)
Time frame: From start of treatment until disease progression
Impact of treatment on biomarkers of Pi3 Kinase pathway (analyses of skin biopsies, circulating markers)
Time frame: From start of treatment until disease progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Results for CBEZ235A2118 can be found on the Novartis Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BEZ235 + paclitaxel, BKM120 + paclitaxel and BEZ235 + paclitaxel + trastuzumab in people with Metastatic or Locally Advanced Solid Tumors, run by Novartis Pharmaceuticals at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, Germany, Spain, Switzerland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose limiting toxicities during the first cycle of treatment. (time frame: First treatment cycle (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.