Clinical Trial Details
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NCT01933815 : Dose-Escalation Study of TPI 287 + Avastin Followed by Randomized Study of the Same Versus Avastin for Glioblastoma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. Histologically proven GBM

2. Disease progression following radiation and TMZ

3. Up to 2 prior relapses allowed

4. Baseline MRI within 17 days of Day 1 & on steroid dosage that has been stable or
decreasing for at least 5 days

5. Recent resection of recurrent or progressive tumor allowed as long as at least 4 weeks
have elapsed from date of surgery and the subject has recovered from surgery

6. Life expectancy >12 weeks

7. Eighteen years old or older

8. KPS equal to or greater than 70

9. Recovered from toxic effects of prior therapy to < Grade 2 per National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) prior to Day 1.
Minimum duration required between prior therapy and Day 1 is:

1. At least 12 weeks from completion of radiation therapy except if there is
unequivocal evidence for tumor recurrence in which case at least 4 weeks

2. 4 weeks from prior cytotoxic therapy

3. 4 weeks from prior experimental drug

4. 6 weeks from nitrosoureas

5. 3 weeks from procarbazine

6. 1 week for non-cytotoxic agents, such as interferon, tamoxifen, & cis-retinoic

10. Adequate bone marrow function (absolute neutrophil count > 1,500/mm3 and platelet
count of > 100,000/mm3), adequate liver function [ALT and AST <3 x upper limit normal
(ULN), alkaline phosphatase <2 x ULN, and total bilirubin <1.5 mg/dL], & adequate
renal function (BUN and creatinine <1.5 x ULN)

11. Minimum hemoglobin of 9 g/dL

12. Males & women of childbearing potential must agree to abstain from sex or use an
adequate method of contraception for the duration of study, & for 6 months after last
dose of study drug

13. Signed & dated informed consent prior to Screening evaluations

Exclusion Criteria:

1. Radiographic evidence of contrast-enhancing tumor crossing midline, leptomeningeal
dissemination, gliomatosis cerebri or infratentorial tumor

2. Evidence or suspicion of disease metastatic to sites remote from the supratentorial

3. Prior treatment with bevacizumab or other anti-vascular endothelial growth factor
(VEGF) drugs

4. Prior treatment with tyrosine-kinase inhibitors targeting VEGF, platelet-derived
growth factor, fibroblast growth factor, tyrosine kinase with immunoglobulin-like and
epidermal growth factor-like domains 2 (TIE-2), or angiopoietin (or their receptors)

5. Prior treatment with histone deacetylase inhibitors or mammalian target of rapamycin
(mTOR) inhibitors

6. Prior treatment with TPI 287

7. Treatment with Enzyme-Inducing Anti-Epileptic Drugs within 2 weeks prior to Day 1

8. Treatment with drugs or herbal supplements known to be strong inhibitors/inducers of
cytochrome P450 3A4 or cytochrome P450 2C8 within 2 weeks prior to Day 1

9. Received more than one course of radiation therapy or more than a total dose of 65 Gy.
May have received radiosurgery as part of initial therapy; however, the dose counts
against the total dose limit.

10. Prior taxane, vincristine, or other microtubule inhibitor chemotherapies for treatment
of GBM or other malignancy

11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1 or anticipation of need for major surgical procedure during the course
of the study

12. Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to Day 1

13. Any condition, including the presence of clinically significant laboratory
abnormalities, which places subject at unacceptable risk if he/she were to participate
in the study or confounds the ability to interpret data from the study, including:

1. Active infection including known AIDS or Hepatitis C or with a fever ?38.5°C
within 3 days prior to enrollment

2. Diseases or conditions that obscure toxicity or dangerously alter drug metabolism

3. Serious intercurrent medical illness (e.g., symptomatic congestive heart failure)

14. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from providing informed consent

15. Inadequately controlled hypertension (defined as systolic blood pressure >140 mmHg
and/or diastolic blood pressure > 90 mmHg)

16. Prior history of hypertensive crisis or hypertensive encephalopathy

17. New York Heart Association Grade II or greater congestive heart failure

18. History of myocardial infarction or unstable angina within 6 months prior to Day 1

19. History of stroke or transient ischemic attack within 6 months prior to Day1

20. Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or
recent peripheral arterial thrombosis) within 6 months prior to Day 1

21. History of hemoptysis (? 1/2 teaspoon of bright red blood per episode) within 1 month
prior to Day 1

22. Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic anticoagulation)

23. Grade 2 or higher peripheral neuropathy per NCI CTCAE

24. History of abdominal fistula or gastrointestinal perforation within 6 months prior to
Day 1

25. Serious, non-healing wound, active ulcer, or untreated bone fracture

26. Proteinuria at Screening. Subjects with a urine dipstick protein ?2+ at Screening
should undergo a 24-hour urine collection and must demonstrate ?1g of protein in 24
hours to be eligible

27. Known hypersensitivity to inactive ingredient of bevacizumab

28. Known hypersensitivity to inactive ingredient of TPI 287

29. Pregnancy or lactation

30. Inability to comply with protocol
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