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PTI-6D2

Phase 1

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

PTI-6D2 development status

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

PTI-6D2 clinical trials

PTI-6D2 · 1 trial · 1 indication

Phase 1 1
NCT00734188Dose Escalation and Safety Study of 188Re-PTI-6D2 in Patients With Metastatic MelanomaMetastatic Melanoma
COMPLETED21 Analytics
PHASE1COMPLETED
Dose Escalation and Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
Metastatic MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the maximum tolerated dose (MTD) of 188Re-PTI-6D2 in patients with metastatic melanoma
Daily/Weekly/Monthy

Secondary Endpoints

to determine safety and tolerability; dose-limiting toxicities; evaluate the anti-tumor activity; to evaluate the HAMA response; and, to further characterize the pharmacokinetics, biodistribution, and dosimetry of 188Re-PTI-6D2
Daily/Weekly/Monthly
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
PTI-6D2DRUGmonoclonal antibody
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must have histologically or clinically confirmed malignant melanoma of one of the following stages (according to 2002 American Joint Committee on Cancer criteria: Appendix C): Unresectable Stage III disease or Stage IV disease * Patients must have measurable disease a...

Countries:Israel
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Frequently asked questions about PTI-6D2

What is PTI-6D2?

PTI-6D2 is an investigational small molecule developed by Filana Therapeutics, Inc. for metastatic melanoma. It has been studied as a radioisotope-labeled agent in a Phase 1 dose escalation and safety trial. The compound is not approved and remains in clinical development.

What is PTI-6D2 used for in metastatic melanoma?

PTI-6D2 is being evaluated for the treatment of metastatic melanoma. Its only clinical study to date was a Phase 1 dose escalation and safety trial in patients with metastatic melanoma. The drug is investigational and has not been approved for any indication.

Who makes PTI-6D2?

PTI-6D2 is being developed by Filana Therapeutics, Inc., which trades under the ticker FLNA. The company is the sponsor of the clinical program for this small molecule in metastatic melanoma.

What phase is PTI-6D2 in?

PTI-6D2 is in Phase 1 development. Its single clinical trial, NCT00734188, was a Phase 1 dose escalation and safety study in metastatic melanoma that has been completed. The drug is investigational and has not received FDA approval.

What clinical trials is PTI-6D2 in?

PTI-6D2 has been studied in one clinical trial, NCT00734188, titled Dose Escalation and Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma. The Phase 1 trial enrolled 21 patients in Israel and is completed. No active trials are ongoing.