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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

Country

City, postcode or hospital

10 sites in 5 countries

Belgium3 sites

Novartis Investigative Site
Brussels, 1000
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Wilrijk, 2610

Other trials in Belgium

Germany2 sites

Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Essen, 45147

Other trials in Germany

Spain2 sites

Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Seville, Andalusia, 41013

Other trials in Spain

Switzerland2 sites

Novartis Investigative Site
Chur, 7000
Novartis Investigative Site
Sankt Gallen, 9007

Other trials in Switzerland

Netherlands1 site

Novartis Investigative Site
Amsterdam, 1066 CX

Other trials in Netherlands

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.

Conditions: Metastatic or Locally Advanced Solid Tumors
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 groups in NCT01285466
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.

Jan 2011Oct 2014

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced Solid Tumors, Recurrent Solid Tumors
RecruitingPhase 1
SI-B036-ST-101 in Advanced/Metastatic Solid Tumors
Locally Advanced /Metastatic Solid Tumors, Locally Advanced / Metastatic Solid Tumors

All Metastatic or Locally Advanced Solid Tumors trials

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
Conditions: Metastatic or Locally Advanced Solid Tumors
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.

Related trials for Metastatic or Locally Advanced Solid Tumors

RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced Solid Tumors, Recurrent Solid Tumors
RecruitingPhase 1
SI-B036-ST-101 in Advanced/Metastatic Solid Tumors
Locally Advanced /Metastatic Solid Tumors, Locally Advanced / Metastatic Solid Tumors

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?

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?

On the ClinicalTrials.gov record for NCT01285466.

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; AzTrials last refreshed its copy on 8 Nov 2026.