NCT01508104

Brief Summary

The purpose of this clinical trial is to determine the effects good or bad of combining BEZ235 along with Everolimus to determine if it is a safe treatment for patients with advanced cancers of different types.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

2.1 years

First QC Date

January 6, 2012

Last Update Submit

August 21, 2017

Conditions

Cancer

Keywords

solid tumorglioblastoma multiformeGBMbrain tumorneuroendocrine tumor

Outcome Measures

Primary Outcomes (1)

  • Dose limiting toxicity

    28 days

Study Arms (1)

BEZ235 and Everolimus

EXPERIMENTAL
Drug: BEZ235Drug: Everolimus

Interventions

BEZ235DRUG

dose escalation 400mg- 1000mg per day

BEZ235 and Everolimus
EverolimusDRUG

dose escalation 2.5 to 5 mg per day

Also known as: RAD001
BEZ235 and Everolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed advanced solid malignancies that are metastatic or unresectable, and for which standard/curative measures do not exist by RECIST 1.1 measureable lesion which is not declining
  • Age ≥ 18 years old at the day of consenting to the study
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • Adequate bone marrow and organ function as defined by laboratory values

You may not qualify if:

  • Previous treatment with PI3K inhibitors
  • Concurrent malignancy or has a malignancy within 3 years of study enrollment, (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
  • Concurrently using other approved or investigational antineoplastic agent
  • Currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, hormonal therapy, etc.)
  • Poorly controlled diabetes mellitus (HbA1c \> 8 %)
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Active cardiac disease
  • Inadequately controlled hypertension (i.e, SBP \>180 mmHg or DBP \>100mmHg)
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea grade ≥ 2, malabsorption syndrome, or small bowel resection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0502, United States

Location

Related Publications (1)

  • Wise-Draper TM, Moorthy G, Salkeni MA, Karim NA, Thomas HE, Mercer CA, Beg MS, O'Gara S, Olowokure O, Fathallah H, Kozma SC, Thomas G, Rixe O, Desai P, Morris JC. A Phase Ib Study of the Dual PI3K/mTOR Inhibitor Dactolisib (BEZ235) Combined with Everolimus in Patients with Advanced Solid Malignancies. Target Oncol. 2017 Jun;12(3):323-332. doi: 10.1007/s11523-017-0482-9.

    PMID: 28357727DERIVED

MeSH Terms

Conditions

NeoplasmsGlioblastomaBrain NeoplasmsNeuroendocrine Tumors

Interventions

dactolisibEverolimus

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • John Morris, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 11, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2014

Study Completion

December 1, 2014

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

US(1)