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Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (STELLAR)

Primary Purpose

Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eflornithine
Lomustine
Lomustine
Sponsored by
Orbus Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Astrocytoma focused on measuring Anaplastic Astrocytoma, Grade 3 Glioma, Glioma, Eflornithine, Brain Cancer, Brain Tumor, Neuro-oncology, Progressive Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma, Progressive Glioma, Recurrent Glioma, Malignant Glioma, Progressive Brain Tumor, Recurrent Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

  • Surgical or biopsy-proven diagnosis of WHO grade 3 AA.

  • First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true:

    1. Gd-contrast lesion margins are not clearly defined,
    2. Gd-contrast lesions are only measurable in one dimension,
    3. Gd-contrast lesion has two perpendicular diameters less than 10 mm,
    4. Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis,
    5. Recent histopathological confirmation of WHO grade 3 AA
  • Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA.
  • Completion of EBRT ≥ 6 months prior to randomization.
  • A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2 FLAIR.
  • Karnofsky Performance Status (KPS) score of ≥ 70.

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not eligible for study participation:

  • MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
  • Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
  • Prior systemic therapy for recurrence of AA.
  • Presence of extracranial or leptomeningeal disease.
  • Prior lomustine use.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study.
  • Pregnant or breastfeeding.

Sites / Locations

  • University of Alabama at Birmingham
  • Saint Joseph's Hospital and Medical Center
  • Kaiser Permanente
  • University of Southern California Norris Comprehensive Cancer Center
  • University of California Irvine Medical Center
  • Kaiser Permanente Center
  • Kaiser Permanente
  • UCSD Moores Cancer Center
  • University of California San Francisco Medical Center
  • John Wayne Cancer Institute
  • University of Colorado
  • University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
  • Piedmont Physicians Neuro-Oncology
  • Winship Cancer Institute
  • Northwestern University
  • Northwestern Medicine CDH Cancer Center
  • The University of Iowa
  • University of Kentucky Chandler Medical Center
  • Norton Cancer Institute - Louisville
  • Louisiana State University Health Sciences Center New Orleans
  • Maine Center for Cancer Medicine and Blood Disorders
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute, Brigham and Women's Hospital
  • Henry Ford Hospital
  • Mayo Clinic Minnesota
  • Saint Luke's Cancer Institute
  • HCA Midwest Division
  • Washington University
  • JFK Medical Center
  • Mount Sinai Hospital
  • Columbia University Medical Center, The Neurological Institute
  • University of North Carolina - Chapel Hill
  • Duke University Medical Center
  • Wake Forest University Health Sciences
  • The Cleveland Clinic, Richard E. Jacobs Health Center
  • OhioHealth Research and Innovation Institute
  • Providence Brain & Spine Institute
  • University of Pennsylvania
  • Thomas Jefferson University Hospital
  • Medical University of South Carolina, Hollings Cancer Center
  • Vanderbilt University
  • Texas Oncology Austin Brain Tumor Center
  • Neuro-Oncology Associates
  • MD Anderson Cancer Center
  • University of Utah
  • Swedish Health Services
  • Universitair Ziekenhuis Leuven
  • Cliniques Universitaires UCL De Mont-Godinne
  • Tom Baker Cancer Center
  • CancerCare Manitoba
  • Ottawa Hospital
  • Sunnybrook Research Institute
  • Princess Margaret Cancer Center
  • Montreal Neurological Institute and Hospital
  • Institut de Cancerologie de l'Ouest - Angers
  • CHRU de Brest
  • Hôpital Pierre Wertheimer - Hospices Civils de Lyon
  • Centre Jean Perrin
  • Centre Georges François Leclerc
  • Hôpital Roger Salengro
  • Hôpital de la Timone
  • Hôpital Universitaire Pitié Salpêtrière
  • Klinik und Poliklinik fur Neurologie der Universitat Regensburg
  • Heinrich-Heine-Universitat Duesseldorf
  • Universitätsklinikum Essen
  • Universitaetsklinikum Hamburg-Eppendorf
  • Fondazione IRCCS - Instituto Neurologico Carlo Besta
  • Istituto Oncologico Veneto
  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
  • Sint Elisabeth Ziekenhuis
  • Vrije Universiteit Medisch Centrum (VUMC)
  • Erasmus Medisch Centrum Daniel den Hoed
  • Universitair Medisch Centrum Utrecht
  • University Hospitals Birmingham NHS Foundation Trust
  • Edinburgh Cancer Centre - Western General Hospital
  • Guy's Hospital
  • The Royal Marsden NHS Foundation Trust
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eflornithine + Lomustine

Lomustine

Arm Description

Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks

Lomustine dosed every 6 weeks

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression-free survival (PFS)
Objective response rate (ORR)

Full Information

First Posted
June 3, 2016
Last Updated
January 19, 2022
Sponsor
Orbus Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02796261
Brief Title
Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
Acronym
STELLAR
Official Title
A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orbus Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.
Detailed Description
This study will consist of 4 study periods of up to 50 months in total, consisting of: Screening Period - A maximum screening duration of 4 weeks. Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months. End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms. Follow-Up Period - Up to approximately 36 months, or until patient death. A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma
Keywords
Anaplastic Astrocytoma, Grade 3 Glioma, Glioma, Eflornithine, Brain Cancer, Brain Tumor, Neuro-oncology, Progressive Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma, Progressive Glioma, Recurrent Glioma, Malignant Glioma, Progressive Brain Tumor, Recurrent Brain Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eflornithine + Lomustine
Arm Type
Experimental
Arm Description
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
Arm Title
Lomustine
Arm Type
Active Comparator
Arm Description
Lomustine dosed every 6 weeks
Intervention Type
Drug
Intervention Name(s)
Eflornithine
Other Intervention Name(s)
DFMO
Intervention Description
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
Intervention Type
Drug
Intervention Name(s)
Lomustine
Other Intervention Name(s)
CCNU, CeeNU, Gleostine
Intervention Description
Lomustine 90 mg/m2 administered orally once every 6 weeks
Intervention Type
Drug
Intervention Name(s)
Lomustine
Other Intervention Name(s)
CCNU, CeeNU, Gleostine
Intervention Description
Lomustine 110 mg/m2 administered orally once every 6 weeks
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
4 years
Title
Objective response rate (ORR)
Time Frame
4 years
Other Pre-specified Outcome Measures:
Title
Clinical benefit response (CBR) based on magnetic resonance imaging (MRI) criteria
Time Frame
4 years
Title
OS rate at 18 months (OS-18)
Time Frame
18 months
Title
Relevance of OS, PFS, ORR, and CBR to commonly used molecular/genetic biomarkers obtained from most recent pre-study tumor samples
Time Frame
4 years
Title
Pharmacokinetic Analysis - Maximum concentrations (Cmax) of eflornithine in plasma will be determined.
Time Frame
1 Month
Title
PK - Area under the curve (AUC) of eflornithine in plasma will be determined.
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for participation in this study: Surgical or biopsy-proven diagnosis of WHO grade 3 AA. First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true: Gd-contrast lesion margins are not clearly defined, Gd-contrast lesions are only measurable in one dimension, Gd-contrast lesion has two perpendicular diameters less than 10 mm, Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis, Recent histopathological confirmation of WHO grade 3 AA Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA. Completion of EBRT ≥ 6 months prior to randomization. A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2 FLAIR. Karnofsky Performance Status (KPS) score of ≥ 70. Exclusion Criteria: Patients who meet any of the following exclusion criteria are not eligible for study participation: MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis. Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed. Prior systemic therapy for recurrence of AA. Presence of extracranial or leptomeningeal disease. Prior lomustine use. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study. Pregnant or breastfeeding.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35401
Country
United States
Facility Name
Saint Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University of Southern California Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Kaiser Permanente Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Kaiser Permanente
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
UCSD Moores Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Piedmont Physicians Neuro-Oncology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Medicine CDH Cancer Center
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60055
Country
United States
Facility Name
The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Norton Cancer Institute - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisiana State University Health Sciences Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Maine Center for Cancer Medicine and Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute, Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Luke's Cancer Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
HCA Midwest Division
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
JFK Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center, The Neurological Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Cleveland Clinic, Richard E. Jacobs Health Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
OhioHealth Research and Innovation Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Providence Brain & Spine Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina, Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology Austin Brain Tumor Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Neuro-Oncology Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Swedish Health Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cliniques Universitaires UCL De Mont-Godinne
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Institut de Cancerologie de l'Ouest - Angers
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Hôpital Pierre Wertheimer - Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hôpital Universitaire Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Klinik und Poliklinik fur Neurologie der Universitat Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Heinrich-Heine-Universitat Duesseldorf
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Fondazione IRCCS - Instituto Neurologico Carlo Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Sint Elisabeth Ziekenhuis
City
Tilburg
State/Province
Noord-Brabant
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum (VUMC)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Erasmus Medisch Centrum Daniel den Hoed
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre - Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

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