Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Lung Cancer, Liver Cancer, Cancer, Brain Cancer, Blood Cancer, Lymphoma, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/19/2017 |
Start Date: | July 20, 2010 |
End Date: | December 9, 2016 |
A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Multiple Myeloma
The main purpose of this first human study with CC-223 is to assess the safety and action of
a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors
unresponsive to standard therapies and to determine the appropriate dose and tumor type for
later-stage clinical trials.
a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors
unresponsive to standard therapies and to determine the appropriate dose and tumor type for
later-stage clinical trials.
Initially, patients will be treated with oral CC-223 for one month. During this time, various
tests (involving blood and urine collections, ECGs, etc) will be performed. Those whose
tumors stabilize or regress may continue receiving treatment for as long as they benefit from
CC-223. Different dose levels of CC-223 will be tested in a dose-rising study design.
tests (involving blood and urine collections, ECGs, etc) will be performed. Those whose
tumors stabilize or regress may continue receiving treatment for as long as they benefit from
CC-223. Different dose levels of CC-223 will be tested in a dose-rising study design.
Inclusion Criteria:
- Histologically-confirmed advanced solid tumor, Non-Hodgkin Lymphoma or multiple
myeloma
- Patients have not tolerated or progressed on standard therapy, and no further standard
therapy is available
- Archival and screening tumor biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (solid tumors), 0-2
(hematologic malignancy)
- Adequate organ function
Exclusion Criteria:
- Prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5
half lives, whichever is shorter, prior to starting study drug or who have not
recovered from side effects of such therapy. Subjects must have recovered from any
effects of recent radiotherapy that might confound the safety evaluation of study drug
- Symptomatic brain metastases (prior Rx and stable metastases are OK)
- Acute or chronic liver or renal disease or pancreatitis
- Diarrhea ≥ Grade 2, impaired GI absorption
- Impaired cardiac function
- Diabetes requiring Rx, glucose >126 mg/dL, HbA1c ≥6.5%
- Peripheral neuropathy ≥ Grade 2
- Pulmonary fibrosis
- Known HIV infection
- Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity in
subjects with HCC
- Pregnant, inadequate contraception
- Most concurrent second malignancies
We found this trial at
11
sites
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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San Francisco, California 94115
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