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

• Status: Terminated
• Trial end date: 2017-10-04
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cerulean Pharma Inc.; NewLink Genetics Corporation

Criteria

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.