Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma
ConditionGlioma, Malignant
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanoPharmaceuticals LLC
About this trial
Glioblastoma is a highly aggressive and fatal form of primary malignant brain tumor with limited treatment options. fb-PMT affects a large group of cancer cell signaling pathways and thus may be effective in heterogeneous, treatment-resistant tumors such as Glioblastoma. fb-PMT also is actively transported across the blood-brain barrier into the brain. This study is being conducted to determine the dose level for further clinical development of fb-PMT to treat recurrent Glioblastoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically proven intracranial glioblastoma, with first or second recurrence
On stable or decreasing dose of steroids, if taken prior to screening
Baseline MRI (with and without contrast) completed with 5 days of starting fb-PMT
Prior completion of and recovery from the effects of standard of care for glioblastoma management with surgery/biopsy and radiotherapy
Disqualifiers
Significant medical illness that is uncontrolled, may obscure toxicity, may dangerously alter drug metabolism, or may compromise ability for study participation
History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for at least 3 months prior to first dose of study drug
Use of bevacizumab or any other experimental drug or therapy within 28 days of study treatment
Prior therapy with fb-PMT or related drugs
Trial design
Design model
Sequential
Treatments tested in this trial
fb-PMT
DrugDaily dosing based on patient weight
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Treatment (fb-PMT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Determined by the number of Treatment-Emergent Adverse Events, including Dose-Limiting Toxicities per patient.
Time frame
15 months2
Incidence of Dose Limiting Toxicities [Safety and Tolerability]
Number of participants with a dose-limiting toxicity during the first cycle (28 days) of treatment at their highest dose level administered.
Time frame
28 DaysSecondary outcomes
1
Establishment of Recommended Phase 2 Dose
Maximum Tolerated Dose, as determined by Dose-Limiting Toxicities.
Time frame
28 DaysSponsors and contacts
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Source ClinicalTrials.gov