Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumors
NCT ID: NCT02380677
Last Updated: 2020-06-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
42 participants
INTERVENTIONAL
2015-04-30
2017-10-04
Brief Summary
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Detailed Description
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For the first 2 cohorts a 1+5 study design will be utilized. A single patient will be enrolled sequentially into cohort 1 and cohort 2. If either patient in cohort 1 or 2 experiences a dose limiting toxicity (DLT) during Cycle 1, then the cohort will be expanded to enroll additional patients up to a total of 6.
As of cohort 3 and for all subsequent cohorts, a 3+3 dose escalation schema will be utilized.
MTD/RP2D will be determined at the dose level when \<2 of 6 patients experience a DLT in a cohort.
The Phase 2a part of the study will be an open-label expansion cohort study. An additional 24 patients with advanced, histologically confirmed solid tumor malignancies will be enrolled. All patients will be assigned to treatment at the MTD/RP2D with CRLX301 as the single agent.
All patients will be followed for safety, tumor response, and progression free survival (PFS) all per RECIST version 1.1 guidelines. Patients will remain on study treatment until they experience progression of disease, unacceptable toxicity, or other specified reason for discontinuation.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Schedule 1 Cohort 1
CRLX301 7.5 mg/m2 IV given every 3 weeks
CRLX301
Schedule 1 Cohort 2
CRLX301 15 mg/m2 IV given every 3 weeks
CRLX301
Schedule 1 Cohort 3
CRLX301 30 mg/m2 IV given every 3 weeks
CRLX301
Schedule 1 Cohort 4
CRLX301 60 mg/m2 IV given every 3 weeks
CRLX301
Schedule 1 Cohort 5
CRLX301 75 mg/m2 IV given every 3 weeks
CRLX301
Schedule 1 Cohort 6
CRLX301 90 mg/m2 IV given every 3 weeks
CRLX301
Schedule 2 Cohort 1
CRLX301 25 mg/m2 IV given weekly
CRLX301
Schedule 2 Cohort 2
CRLX301 35 mg/m2 IV given weekly
CRLX301
Schedule 2 Cohort 3
CRLX301 45 mg/m2 IV given weekly
CRLX301
Schedule 2 Cohort 4
CRLX301 54 mg/m2 IV given weekly
CRLX301
Schedule 2 Cohort 5
CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off
CRLX301
Phase 2a expansion cohort
CRLX301 75mg/m2 IV given every 3 weeks
CRLX301
Interventions
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CRLX301
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of histologically or cytologically confirmed, advanced solid tumor malignancy that is refractory to or not a candidate for standard therapy
3. ECOG 0 or 1
4. Life expectancy \>12 weeks
5. Fertile males or females of childbearing potential agree to use adequate contraception prior to study entry
6. Negative urine pregnancy test
Exclusion Criteria
2. Prolongation of QT/QTc interval
3. Women who are pregnant or nursing
4. Any known HIV infection or AIDS or any concurrent infection requiring IV antibiotics
5. Any chronic or concurrent acute liver disease, including viral hepatitis
6. Primary brain malignant tumors
7. Known metastases to the brain
8. Uncontrolled hypertension
9. Concurrent participation in any other investigational study
10. Concurrent treatment with anticoagulation medication, unless approved by Sponsor
11. History of stroke, deep venous thrombosis (DVT), or transient ischemic attack (TIA)
12. History of other cancer type, except for cutaneous basal cell or squamous cell carcinoma, or cervical or prostate cancer in situ, within the last 2 years prior to C1D1
13. Uncontrolled concurrent disease or illness
14. History of severe hypersensitivity reaction to taxanes
15. Peripheral neuropathy exclusions
16. Other condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study.
18 Years
ALL
No
Sponsors
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NewLink Genetics Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Elizabeth Dees, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
MD Anderson
Houston, Texas, United States
Countries
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References
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Piha-Paul SA, Thein KZ, De Souza P, Kefford R, Gangadhar T, Smith C, Schuster S, Zamboni WC, Dees CE, Markman B. First-in-human, phase I/IIa study of CRLX301, a nanoparticle drug conjugate containing docetaxel, in patients with advanced or metastatic solid malignancies. Invest New Drugs. 2021 Aug;39(4):1047-1056. doi: 10.1007/s10637-021-01081-x. Epub 2021 Feb 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CRLX301-101
Identifier Type: -
Identifier Source: org_study_id
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