Clinical trial · Interventional
TPI 287 in Patients With Recurrent Glioblastoma Multiforme
A Phase 2 Open-Label Study of the Efficacy of TPI 287 in Patients With Glioblastoma Multiforme That Has Recurred or Progressed Following Prior Therapy With Radiation Plus Temozolomide
NCT01113463CI-TRIAL-00024515terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Accrual
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if TPI 287 can help to control glioblastoma. The safety of this drug will also be studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TPI 287 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TPI 287
- description
- TPI 287 Starting dose 160 mg/m\^2 intravenous (IV) every 3 weeks
- interventionNames
- Drug: TPI 287
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS) at 6 Months
- timeFrame
- 6 months (following nine 21-day cycles)
- description
- PFS defined as number of participants alive without documented evidence of disease progression ("progression free") at 6 months. Progression-free survival calculated from the date of Day 1 Cycle 1 to the date that criteria for progression of disease is first seen. Progression is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have histological or cytological documentation of GBM. Patients will be eligible if the original histology was lower grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made. 2. Patients must have supratentorial GBM that has radiographic recurrence or progression following prior radiation therapy and temozolomide for GBM or lower grade glioma, or the appearance of new lesions on scan, or clinical or neurologic worsening despite stable disease on the last 2 scans. 3. Patients must have measurable disease on radiologic scan. 4. Patients must be \>/= 18 years of age. 5. Patients must have a Karnofsky performance status \>/= 60%. 6. Patients must have adequate bone marrow as evidenced by an absolute neutrophil count \>/=1,500/uL and a platelet count \>/=100,000/uL. 7. Patients must have adequate renal function as evidenced by serum creatinine \<= the upper limit of normal (ULN) 8. Patients must have adequate hepatic function as evidenced by serum total bilirubin \</= 2.0 mg/dL and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) \</= 3 times the ULN. 9. Patients must have recovered from the effects of any prior surgery, radiotherapy or other chemotherapy with any therapy related adverse events revolved to \</= grade 1, and at least 12 weeks must have elapsed from the completion of radiotherapy, and 3 weeks from the last dose of Temozolomide. 10. Women of child-bearing potential (includes women who are menopausal for less than 1 year and not surgically sterilized) must have a negative urine or serum pregnancy test at screening. 11. Sexually active patients must agree to use adequate contraception (two barrier methods) for the duration of the study. 12. Patients or their legal representative must be able to read, understand and sign an informed consent form (ICF). Exclusion Criteria: 1. Patients who have received more than one course of radiation therapy or more than a total dose of 65 grey (Gy). Patients may have received radiosurgery as part of the initial therapy (i.e., in addition to one course of radiation therapy); however, the dose used for the radiosurgery counts against the total dose limit listed above. 2. Patients who have had a second surgery for recurrent disease who have no radiologically apparent residual disease (contrast-enhanced MRI imaging must have been performed within 24-48 hours post-operatively). 3. Patient who have received any cytotoxic chemotherapy for treatment of GBM other than temozolomide (Gliadel trademarked as part of the initial therapy is permitted). However, patients who have received prior biologic therapy will be eligible. 4. Patients who are receiving concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital and primidone) or who received EIAEDs within 2 weeks prior to the first dose of study drug. 5. Patients who are not on a stable or decreasing steroid dose for the previous week prior to the study enrollment. 6. Patients with an active infection or with a fever \>/= 38.5°C within 3 days prior to the study enrollment. 7. Patients who have history of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancer or cervical intra-epithelial neoplasia for which the patient has been disease-free for at least 3 years. 8. Patients with Grade 2 or higher peripheral neuropathy. 9. Patients with New York Heart Association(NYHA) Class 3 or 4 congestive heart failure. 10. Patients with known HIV or Hepatitis B or C. 11. Patients who are pregnant or lactating. 12. Patients with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the patient's ability to sign the ICF or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results. 13. Patients who have received prior bevacizumab therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.