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188Re-PTI-6D2

Phase 1

Metastatic Melanoma | Small molecule | Oncology |Filana Therapeutics, Inc.|Last Updated: Jul 14, 2011

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

188Re-PTI-6D2 · 1 trial · 1 indication

Phase 1 1
NCT00399113Safety Study of 188Re-PTI-6D2 in Patients With Metastatic MelanomaMetastatic Melanoma
COMPLETED12 Analytics
PHASE1COMPLETED
Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
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Study Endpoints

Primary Endpoints

To select the amount of unlabeled PTI-6D2 to administer immediately prior to a tracer dose of 188Re-PTI-6D2 in order to achieve preferred tumor targeting
To generate pharmacokinetic (PK) and biodistribution data of 188Re-PTI-6D2 in patients with metastatic melanoma in order to estimate radiation doses absorbed to tumor and critical organs
To determine the frequency of HAMA response associated with 188Re-PTI-6D2 administration
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
188Re-PTI-6D2DRUGmonoclonal antibody
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histologically confirmed Stage IIIc (unresectable) or Stage IV metastatic melanoma; * measurable disease; * at least 18 years of age; * Karnofsky status at least 50%; * life expectancy \> 3 months; * at least 4 weeks since prior therapy; * adequate organ and marrow function de...

Countries:Israel
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Frequently asked questions about 188Re-PTI-6D2

What is 188Re-PTI-6D2 used for?

188Re-PTI-6D2 is an investigational therapy being studied for the treatment of metastatic melanoma. It was evaluated in a Phase 1 safety study in patients with metastatic melanoma. The drug has not been approved for any indication and remains in clinical development.

Who is developing 188Re-PTI-6D2?

188Re-PTI-6D2 is being developed by Filana Therapeutics, Inc., which trades under the ticker FLNA. The company sponsored the Phase 1 trial of the drug in metastatic melanoma.

What phase is 188Re-PTI-6D2 in?

188Re-PTI-6D2 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not received FDA approval.

What clinical trials is 188Re-PTI-6D2 in?

188Re-PTI-6D2 has been evaluated in one completed Phase 1 trial, NCT00399113, titled "Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma." The trial enrolled 12 patients in Israel and was an uncontrolled, non-randomized study.

Is 188Re-PTI-6D2 biomarker-selected?

Yes, 188Re-PTI-6D2 is a biomarker-selected therapy. Its Phase 1 trial in metastatic melanoma, NCT00399113, required patients to meet a biomarker criterion for enrollment. The study enrolled 12 adults and was completed.