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Esophageal CancerPhase 2NCT01806649

BKM120 in Esophageal Squamous Cell Carcinoma After Failure of First Line Chemotherapy

A Phase 2 study testing BKM120 in people with Esophageal Cancer, run by Prince of Songkla University at 1 site in Thailand.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

There is a need for more effective therapy for patients with esophageal squamous cell carcinoma who developed disease progression after first line therapy. Currently, there is no standard second-line therapy for this disease. BKM-120 is a pan-PI3K inhibitor currently tested in clinical trials. Read more about this study

Who is it for?
Any age
Conditions the study is for
Esophageal Cancer
What is being tested?
BKM120
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteThailand
Study dates
1 Jul 2013to 30 Apr 2016
Phase
Phase 2
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient has provided a signed Informed Consent Form (ICF) obtained prior to any screening procedure.
  • Age ≥ 18 years old
  • Histologically confirmed diagnosis of esophageal squamous cell carcinoma and available archival tissue for evaluation of further studies.
  • Metastatic or unresectable disease
  • Received one prior chemotherapy or biological therapy regimen for unresectable or metastatic disease
  • More than 30 days since prior chemotherapy, surgery, radiotherapy, or investigational agents
Show all 19Show fewer
  • Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
  • No evidence of brain metastasis
  • ECOG ≤ 2
  • Patient has adequate bone marrow and organ function
  • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Hemoglobin ≥ 9.0 g/dL
  • INR ≤ 2
  • Potassium, calcium, magnesium within normal limits for the institution
  • Serum Creatinine ≤ 1.5 x ULN or Creatinine clearance > 60 mL
  • AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
  • Serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
  • Fasting serum glucose < 1.5 times ULN

Who cannot join

  • Patient has received previous treatment with PI3K inhibitors
  • Patient has symptomatic CNS metastases
  • Patients with controlled and asymptomatic CNS metastases may participate in this trial. As such, the patient must have completed any prior treatment for CNS metastases > 28 days (including radiotherapy and/or surgery) prior to enrollment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
  • Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ.
  • Patient has any of the following mood disorders as judged by the Investigator or a Psychiatrist, or meets the cut-off score of ≥ 10 in the PHQ-9 or a cut-off of ≥ 15 in the GAD-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of the PHQ-9)
  • Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) ≥ CTCAE grade 3 anxiety
Show all 26Show fewer
  • Patient is concurrently using other approved or investigational antineoplastic agent
  • Patient has had major surgery within 28 days prior to starting study drug or has not recovered from major side effects of the surgery
  • Patient has poorly controlled diabetes mellitus(HbA1c > 8 %)
  • Patient has active cardiac disease including any of the following:
  • LVEF < 50%
  • QTc > 480 msec on screening ECG (using the QTcF formula)
  • Angina pectoris that requires the use of anti-anginal medication
  • Ventricular arrhythmias except for benign premature ventricular contractions
  • Supraventricular and nodal arrythmias requiring a pacemaker or not controlled with medication
  • Conduction abnormality requiring a pacemaker
  • Valvular disease with documented compromise in cardiac function
  • Symptomatic pericarditis
  • Patient has a history of cardiac dysfunction including any of the following;
  • Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV)
  • Documented cardiomyopathy
  • Patient is currently receiving treatment with QT prolonging medication known to have a risk to induce Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug
  • Inability to swallow, impaired gastrointestinal (GI) function, or GI disease that would significantly alter the absorption of study drugs or preclude the use of oral medications
  • Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate her participation in the clinical study (e.g.,chronic pancreatitis, active chronic hepatitis etc.)
  • Patient is currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Songklanagarind Hospital, Prince of Songkla University

    Hat Yai, Changwat Songkhla, 90110

Other trials in Thailand

About this study

Official title: A Phase II Study of BKM120; a Pan-PI3K Inhibitor in Patients With Esophageal Squamous Cell Carcinoma After Failure of First Line Chemotherapy

There is a need for more effective therapy for patients with esophageal squamous cell carcinoma who developed disease progression after first line therapy. Currently, there is no standard second-line therapy for this disease.

BKM-120 is a pan-PI3K inhibitor currently tested in clinical trials. In a cellular model of oral-esophageal carcinogenesis, it has shown that EGFR overexpression activated PI3/AKT pathway. Therfore, there is interest to see the efficacy and safety of BKM120 in this setting.

Being tested
BKM120
Keywords
esophageal cancer, second line therapy, BKM120
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BKM120Drug

Study groups in NCT01806649
Study groupRoleWhat they receive
BKM120ExperimentalBKM120, starting at 100 mg oral once daily
Receives: Drug: BKM120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. disease control rate

    16-week disease control rate using RECIST 1.1 criteria

    Measured: 16 weeks

Secondary outcomes (3)

  1. safety

    Safety data will be assessed at each study visit using CTCAE version 4.0

    Measured: each follow up visit, assessed up to 12 months

  2. progression-free survival

    Measured: Time from day 1 to date of documented disease progression or death, assessed up to 12 months

  3. overall survival

    Measured: Time from day 1 to date of death, assessed up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2013 (estimated)
  2. Study start1 Jul 2013
  3. Primary completion30 Apr 2016
  4. Study completion30 Apr 2016

Why it stopped: Sponsor terminated to continue any clinical trials with study drug

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01806649
Sponsor's protocol ID
551691411
Status last verified
Oct 2021
First submitted
1 Mar 2013
Last updated
11 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Bendell JC, Rodon J, Burris HA, de Jonge M, Verweij J, Birle D, Demanse D, De Buck SS, Ru QC, Peters M, Goldbrunner M, Baselga J. Phase I, dose-escalation study of BKM120, an oral pan-Class I PI3K inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2012 Jan 20;30(3):282-90. doi: 10.1200/JCO.2011.36.1360. Epub 2011 Dec 12.

    PubMed 22162589

  • Heeg S, Hirt N, Queisser A, Schmieg H, Thaler M, Kunert H, Quante M, Goessel G, von Werder A, Harder J, Beijersbergen R, Blum HE, Nakagawa H, Opitz OG. EGFR overexpression induces activation of telomerase via PI3K/AKT-mediated phosphorylation and transcriptional regulation through Hif1-alpha in a cellular model of oral-esophageal carcinogenesis. Cancer Sci. 2011 Feb;102(2):351-60. doi: 10.1111/j.1349-7006.2010.01796.x. Epub 2010 Dec 12.

    PubMed 21156006

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BKM120 in people with Esophageal Cancer, run by Prince of Songkla University at 1 site in Thailand.

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 19 inclusion and 26 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: stopped early, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Sponsor terminated to continue any clinical trials with study drug). Results are not available in the source record.

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?

disease control rate (time frame: 16 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 NCT01806649, which also lists 2 linked publications.

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 11 Oct 2021.

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