A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 17
Updated:1/5/2019
Start Date:August 29, 2016
End Date:November 30, 2019

Use our guide to learn which trials are right for you!

A Phase 1, Open-Label, Dose-Escalation Study of Olaratumab as a Single Agent and in Combination With Doxorubicin, Vincristine/Irinotecan, or High-Dose Ifosfamide in Pediatric Patients With Relapsed or Refractory Solid Tumors

The main purpose of this study is to evaluate the safety of different doses of olaratumab and
to determine which dose should be used for future pediatric studies. The present study is
open to children with advanced cancer or cancer that has spread to another part of the body.
The study has three parts. In the first two parts, a specific dose of olaratumab will be
given in 21 day cycles, followed by one of three standard chemotherapy regimens. In the third
part, a specific dose of olaratumab will be given with one of three standard chemotherapy
regimens in 21 day cycles. Participants will only enroll in one part.


Inclusion Criteria:

- The participant must have histological or cytological evidence of a diagnosis of solid
tumor, excluding lymphomas and melanoma, but including central nervous system (CNS)
tumors, that is relapsed or refractory, not be amenable to curative treatment.

- The participant has the presence of measurable and/or nonmeasurable but evaluable
disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST Version
1.1). Response Assessment in Neuro-Oncology (RANO) Criteria or Macdonald Criteria
should be used for CNS tumors.

- The participant has a Lansky (<16 years of age) or Karnofsky (≥16 years of age)
performance score of at least 50.

- The participant has adequate hematologic, organ, and coagulation function ≤2 weeks (14
days) prior to first dose of study drug:

- Absolute neutrophil count (ANC) ≥750 cubic millimeters (mm³)

- Platelets ≥75,000/mm³

- Hemoglobin ≥8 grams per deciliter (g/dL)

- Total bilirubin (sum of conjugated + unconjugated) ≤1.5 x upper limit of normal
(ULN) for age

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN

- Serum creatinine is based on age/gender

- Adequate coagulation function as defined by International Normalized Ratio ≤1.5
or prothrombin time ≤1.5 x ULN, and partial thromboplastin time ≤1.5 x ULN

- Both female and male participants of child-bearing potential must agree to use highly
effective contraceptive precautions during the trial and up to 3 months following the
last dose of olaratumab, or longer for other study drugs according to their label.

- Participants must have fully recovered from the acute toxic effects of all prior
anticancer therapies or must adhere to post-treatment conditions as follows:

- Myelosuppressive chemotherapy

- Hematopoietic growth factors

- Biologic (anti-neoplastic agent)

- Antibody therapy

- Radiation

- Stem cell infusion without traumatic brain injury

- Corticosteroids

Exclusion Criteria:

- Have received treatment within 21 days of the initial dose of olaratumab with an
investigational product or non-approved use of a drug or device or are concurrently
enrolled in any other type of medical research judged not to be scientifically or
medically compatible with this study.

- Participants that have had bone marrow or solid organ transplant are excluded.

- The participant has an active fungal, bacterial, and/or known severe viral infection
including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis
(screening is not required).

- Female participants who are pregnant or breastfeeding are excluded.

- If the participant is to be enrolled in the doxorubicin combination arm, a left
ventricular dysfunction (LVEF < 50%) or shortening fraction of <27% by echocardiogram
(either multigated acquisition [MUGA] or echocardiogram [ECHO] are required, not
both).

- Participants that have received prior anthracycline therapy if the participant is to
be enrolled in the doxorubicin combination arm.
We found this trial at
21
sites
5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Theodore W Laetsch
Phone: 214-648-3081
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Jaszianne Tolbert
Phone: 816-302-6801
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Leo Mascarenhas
Phone: 323-361-2529
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Michael W Bishop
Phone: 901-595-2220
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
?
mi
from
Memphis, TN
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Scott C Borinstein
Phone: 615-936-1762
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
Principal Investigator: Mark Fluchel
Phone: 801-662-1680
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Aurora, Colorado 80045
Principal Investigator: Margaret Ellen Macy
Phone: 7207776458
?
mi
from
Aurora, CO
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Steven G DuBois
Phone: 617-632-5460
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Charlotte, North Carolina 28204
Principal Investigator: Chad Jacobsen
Phone: 704-381-6810
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chuo-Ku, Tokyo 10400
Principal Investigator: Chitose Ogawa
Phone: 81120360605
?
mi
from
Chuo-Ku,
Click here to add this to my saved trials
Dallas, Texas 75246
Principal Investigator: Maurizio Ghisoli
Phone: 972-566-3090
?
mi
from
Dallas, TX
Click here to add this to my saved trials
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Jodi Muscal
Phone: 832-824-4632
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Kamnesh Pradhan
Phone: 317-944-8784
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Miami, Florida 33136
Principal Investigator: Matteo M Trucco
Phone: 305-243-4830
?
mi
from
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
Principal Investigator: Brenda J Weigel
Phone: 612-625-8929
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New Hyde Park, New York 11040
Principal Investigator: Julie Krystal
Phone: 718-470-3460
?
mi
from
New Hyde Park, NY
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Emily Slotkin
Phone: 212-639-5952
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Pooja Hingorani
Phone: 602-933-0920
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
San Francisco, California 94143
Principal Investigator: Kieuhoa Vo
Phone: 415-476-3831
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Seattle, Washington 98105
Principal Investigator: Douglas Hawkins
Phone: 206-987-2106
?
mi
from
Seattle, WA
Click here to add this to my saved trials
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: AeRang Kim
Phone: 202-476-2800
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
?
mi
from
Washington,
Click here to add this to my saved trials