Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumors



Status:Terminated
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:April 2015
End Date:October 4, 2017

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Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumor Malignancies

A Phase 1/2a, open-label, dose-escalation study with enrollment in Phase 1 to continue until
determination of the Maximum Tolerated Dose (MTD) /Recommended Phase 2a Dose (RP2D), and then
enrollment into Phase 2a expansion cohorts will be initiated.

Phase 1 is an open-label, dose-escalation protocol. It is anticipated that up to 36 patients
will be enrolled in Phase 1. All patients will be assigned to treatment with CRLX301 as the
single agent.

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.

Inclusion Criteria:

1. Male or female ≥18 years of age

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:

1. Uncontrolled grade 2 or greater toxicity except alopecia

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.
We found this trial at
3
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Tara Gangadhar, MD
Phone: 215-662-7730
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Elizabeth C Dees, MD
Phone: 919-966-3036
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Houston, Texas 77030
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Houston, TX
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