Anti-Infective Agents

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Vadimezan

DMXAA, given intravenously over 20 minutes. Patients were to each undergo six doses of treatment at weekly intervals, receiving each of six doses (300, 600, 1200, 1800, 2400 and 3000 mg/m2)

DMXAA

Mark McKeage

Michael Jameson

Mark Jeffery

This was a phase I study aimed at identifying safe doses of DMXAA (now known as ASA404) to be used in future combination studies with chemotherapy.

This was a multi-centre randomized, double blind study to further characterize the effect of DMXAA on QTc interval, ophthalmic safety and pharmacodynamic effects on tumour blood flow.

Patients with refractory tumors were to each undergo six doses of treatment at weekly intervals, receiving each of six doses of DMXAA (300, 600, 1200, 1800, 2400 and 3000 mg/m2)

Phase I Safety Study of DMXAA in Refractory Tumors

5,6-Dimethylxanthenone-4-Acetic Acid (DMXAA) in the Treatment of Refractory Tumors: A Phase I Multicentre Doubleblind Randomized Six-Way Intrapatient Dose-Ranging Crossover Safety Study.

Antisoma Research

Chief Medical Officer

Neoplasms

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Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Rare Diseases

Fibromatosis, Aggressive

Aggression

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Desmoid Tumor

Gamma Secretase Inhibitors and Modulators

Nirogacestat

Enzyme Inhibitors

Two patients enrolled in this study will continue receiving 80mg BID doses of PF-03084014, which was the same dose/schedule of their latest cycle on protocol A8641014. PF-03084014 will be administered twice a day in the morning and evening divided by approximately 12 hours. PF-03084014 should be administered in cycles of 21 days continuously.

PF-03084014

Wells Messersmith, MD

This is a single-center, open label, non randomized, compassionate use protocol in patients with advanced solid tumor malignancies who were previously enrolled in the phase I study (NCT00878189) of this agent.

This is an expanded access-physician sponsored trial of PF-03084014, a novel gamma-secretase inhibitor being developed for cancer therapy. This trial is designed for patients who have been on a previous Industry-sponsored phase I trial using PF-03084014 for\> 1 year. The study is designed to evaluate the safety of prolonged oral administration of single agent PF-03084014. There are two study subjects with desmoid tumor who have been on the trial for a prolonged period of time (54 and 77 months, respectively) with either stable disease or response, indicating significant clinical benefit for a patient population in which there are few options. The goal of this protocol is to allow these subjects, who are clearly benefiting from PF-03084014, to continue to receive it

Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies

Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies: Continuing Study Drug Administration in Desmoid Patients Receiving Clinical Benefit

SpringWorks Therapeutics, Inc.

University of Colorado, Denver

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Safety Study of DMXAA in Refractory Tumors	NCT00856336	Refractory Tumo...	DMXAA	18 Years -	Antisoma Research
Phase I Safety Study of DMXAA in Refractory Tumors	NCT00856336	Refractory Tumo...	DMXAA	18 Years -	Antisoma Research
Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies	NCT02955446	Neoplasm Desmoid Tumor	PF-03084014	16 Years - 101 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for refractory tumors