Study of Dalantercept and Axitinib in Patients With Advanced Renal Cell Carcinoma



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:December 2012
End Date:November 2017

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

A Phase 2 Randomized, Double-Blind Study of Dalantercept and Axitinib Compared to Placebo and Axitinib in Patients With Advanced Renal Cell Carcinoma

The purpose of Part 1 of this study is to evaluate the safety and tolerability of
dalantercept in combination with axitinib in patients with advanced renal cell carcinoma
(RCC) to determine the recommended dose level of dalantercept in combination with axitinib
for Part 2.

The purpose of Part 2 of this study is to determine whether treatment with dalantercept in
combination with axitinib prolongs progression free survival (PFS) compared to axitinib alone
in patients with advanced renal cell carcinoma (RCC).


Key Inclusion Criteria:

- Histologically confirmed, advanced, predominantly clear cell renal cell carcinoma
(RCC).

- Part 1: Progression of disease following up to three lines of prior therapy, including
at least one approved VEGF receptor tyrosine kinase inhibitor for RCC. Adjuvant
therapy is permitted as one line of prior therapy.

- Part 2: Progression of disease following one VEGF pathway inhibitor for RCC (e.g.
sunitinib, pazopanib, sorafenib, bevacizumab, tivozanib, or cabozantinib) inclusive of
adjuvant therapy if there was documented disease progression during treatment.
Patients may have received one additional line of an approved mTOR kinase inhibitor
(e.g. everolimus, temsirolimus). Prior exposure to investigational and/or approved
anticancer immune therapies is permitted.

- A minimum of 1 week since the last dose of prior therapy (a minimum of 4 weeks since
anticancer immune therapy or bevacizumab +/- interferon).

- Measurable disease that is evaluable by Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Life expectancy of at least 12 weeks.

- Clinical laboratory values within acceptable ranges within 72 hours prior to study day
1.

Key Exclusion Criteria:

- Clinically significant organ/system disease unrelated to RCC that in the judgment of
the investigator should preclude treatment with dalantercept or axitinib.

- Clinically significant cardiovascular risk.

- Known CNS metastases or leptomeningeal disease:

For Part 1, patients with CNS metastases treated with whole brain radiotherapy, gamma
knife, and/or surgery who are considered stable by CNS imaging and are not being treated
with corticosteroids 6 weeks prior to study day 1 may be enrolled.

For Part 2, patients with CNS metastases treated stereotactic radio-surgery (SRS), and/or
surgery who are considered stable by CNS imaging for at least 2 months prior to enrollment
and are not being treated with corticosteroids 6 weeks prior to study day 1 may be
enrolled.

- Any active malignancy, other than RCC, for which chemotherapy or other anti-cancer
therapy is indicated. Patients with adequately treated non-melanoma skin cancer, in
situ cancer, or other cancer from which the subject has been disease-free for at least
3 years will be permitted.

- Any lesion invading or having encasement ≥ 180 degrees around the wall of a major
blood vessel as assessed by computed tomography (CT) scan and/or magnetic resonance
imaging (MRI).

- Radiotherapy within 2 weeks prior to study day 1.

- Lack of recovery from toxic effects of previous treatment for RCC ≤ grade 1 with the
exception of alopecia, unless stabilized under adequate medical control.

- Patients undergoing renal dialysis.

- Major surgery within 4 weeks prior to study day 1 (patients must have recovered
completely from any previous surgery prior to study day 1).

- Any active infection requiring antibiotic therapy within 2 weeks of study day 1.

- Anti-coagulation therapy. Aspirin, other anti-platelet agents, and low molecular
weight heparin are permitted unless the investigator deems the patient is at a
significant risk for bleeding.

- Current use or anticipated inability to avoid potent CYP3A4/5 inhibitors or inducers
(please refer to the Inlyta® [axitinib] prescribing information) during participation
in the study.

- Peripheral edema requiring medical intervention within 2 weeks prior to study day 1.

- Bleeding diathesis including clinically significant platelet disorders or active
hemoptysis (defined as bright red blood of ≥ 1/2 teaspoon [2.5 mL] in any 24 hour
period) within 6 months prior to study day 1. For clinically significant epistaxis
within 4 weeks prior to study day 1, no risk of further bleeding must be clearly
documented.

- Known history of hereditary hemorrhagic telangiectasia (HHT).

- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections or positive
human immunodeficiency virus (HIV) antibody results. Patients with sustained virologic
response to HCV treatment or immunity to HBV from prior infection without cirrhosis
may be included.

- History of severe (defined as ≥ grade 3, using the National Cancer Institute Common
Toxicity Criteria for Adverse Events, version 4.0 [NCI-CTCAE] v4 current active minor
version) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins
or excipients (10 mM Tris buffered saline) in the investigational agent.

- Any prior treatment with dalantercept or any other agent targeting ALK1 pathway.

- Any prior treatment with axitinib.

- A morbidity (per the prescribing information) that would require starting a patient at
a reduced dose of axitinib.

- Treatment with another investigational drug (with the exception of anticancer immune
therapy) or device, or approved therapy for investigational use, within 5 times the
half-life of the drug or within 3 weeks prior to study day 1 if the half life is not
known.

- Pregnant or lactating female patients.
We found this trial at
36
sites
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
?
mi
from
Washington,
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Aurora, Colorado 80012
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78745
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bethlehem, Pennsylvania
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Burlington, Massachusetts 01805
?
mi
from
Burlington, MA
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1200 West Loyola Avenue
Chicago, Illinois 60626
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
Hackensack, New Jersey
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Houston, Texas 77024
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Irvine, CA
Click here to add this to my saved trials
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15232
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Stanford, California 94305
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Tualatin, Oregon 97062
?
mi
from
Tualatin, OR
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Winchester, Virginia 22601
?
mi
from
Winchester, VA
Click here to add this to my saved trials