OXi4503 will be administered weekly for 3 weeks followed by a week with no treatment. The starting dose will be 0.06 mg/m2 given as an intravenous infusion over 10 minutes.

OXi4503

The purpose of this study is to establish the Maximum Tolerated Dose (MTD) of OXi4503 given by weekly infusions to patients with advanced solid tumors.

Safety Study of OXi4503 (a Vascular Disrupting Agent) Given by 3 x Weekly Intravenous Infusions to Patients With Advanced Solid Tumors

A Phase I Trial of OXi4503 (a Vascular Disrupting Agent) Given by 3 Weekly Intravenous Infusions to Patients With Advanced Solid Tumors.

Cancer Research UK

Mateon Therapeutics

All Drugs and Chemicals

Tubulin Modulators

5.0 mg/2ml; 1.0, 2.0, 3.3, 5, 7, 9 \~ mg/m2; Day 1, Day 8 every 3 weeks

CKD-516 inj

Yung-Jue Bang, MD., PhD.

A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection on a weekly schedule in patients with advanced solid cancers failed to standard therapy. The usefulness of the this regimen is evaluated by response rate, progression free survival and vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI).

OBJECTIVES:

* I. Determine the maximum tolerated dose of CKD-516 administered at single doses every 21 days in patients with advanced solid tumors.
* II. Determine both the toxicity and dose limiting toxicity of this regimen in these patients.
* III. Determine the plasma and urine pharmacokinetics of CKD-516.
* IV. Gather preliminary data regarding possible antitumor effects in those patients with measurable diseae. Assess the effects of CKD-516 on tumor blood flow using DCE-MRI scanning techniques, and establish the dose at which these effects occur.

OUTLINE: This is an open label, dose escalation study. Patients receive CKD-516 IV over 30 minutes on day 1, 8 every 3 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3\~6 patients receive escalating doses of CKD-516 until the maximum tolerated dose(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers

Phase I Clinical Trial to Assess the Safety and Pharmacokinetic Profile of CKD-516 in Patients With Advanced Solid Cancers Failed to Standard Therapy

Seoul National University Hospital

Chong Kun Dang Pharmaceutical

Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Antineoplastic Agents

Bevacizumab

Angiogenesis Inhibitors

Fosbretabulin

Combretastatin

Antineoplastic Agents, Immunological

Growth Inhibitors

Antimitotic Agents

Combretastatin A4 Phosphate (CA4P)

Bevacizumab (Avastin)

Paul Nathan, MD

Hillori Connors, MS

Peter Harris, MD

The purpose of this study is to determine the safety and tolerability of three dose levels of combretastatin A4 phosphate (CA4P) given intravenously (IV) in combination with bevacizumab every 14 days in patients with advanced solid tumors. The maximum tolerated dose will be defined if it is at one of the three dose levels under study.

Safety Study of Increasing Doses of Combretastatin in Combination With Bevacizumab (Avastin) in Patients With Advanced Solid Tumors

OXC4P1-105: A Phase I Study of the Safety, Tolerability, and Antitumor Activity of Escalating Doses of Combretastatin A4 Phosphate Given in Combination With Bevacizumab to Subjects With Advanced Solid Tumors

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Docetaxel

Hormones

Vadimezan

AS1404 (DMXAA)

Roberto Pili, MD

The purpose of this trial is to confirm a safe dose of AS1404, to be given with docetaxel, and to see whether adding AS1404 and docetaxel together improves the outcome of the treatment, when compared to docetaxel alone.

The overall aim of this study is to determine the safety, tolerability and efficacy of AS1404 in combination with docetaxel in patients with hormone refractory metastatic prostate cancer.

Study of AS1404 With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

An Open Label, Randomized, Phase II Study of AS1404 in Combination With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

Antisoma Research

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Liver Extracts

OXi4503 administered IV on Days 1, 8, and 15 of each 28-day cycle.

Combretastatin A1 Diphosphate (OXi4503)

Michael Brown, MD

Jason Lickliter, MD

Paul Mainwaring, MD

Michael Millward, MD

The purpose of this study is to determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.

Safety Study of Increasing Doses of Combretasatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Hepatic Tumor Burden

A Multicenter, Open-label Phase 1b/2 Study to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Primary or Secondary Hepatic Tumor Burden

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of OXi4503 (a Vascular Disrupting Agent) Given by 3 x Weekly Intravenous Infusions to Patients With Advanced Solid Tumors	NCT00977210	Solid Tumors	OXi4503	18 Years -	Mateon Therapeutics
Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers	NCT01028859	Unspecified Adu...	CKD-516 inj	20 Years - 75 Years	Chong Kun Dang Pharmaceutical
Safety Study of Increasing Doses of Combretastatin in Combination With Bevacizumab (Avastin) in Patients With Advanced Solid Tumors	NCT00395434	Tumors	Combretastatin ... Bevacizumab (Av...	18 Years -	Mateon Therapeutics
Study of AS1404 With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer	NCT00111618	Prostate Cancer	AS1404 (DMXAA)	18 Years -	Antisoma Research
Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers	NCT01028859	Unspecified Adu...	CKD-516 inj	20 Years - 75 Years	Chong Kun Dang Pharmaceutical
Safety Study of Increasing Doses of Combretasatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Hepatic Tumor Burden	NCT00960557	Neoplasm Metast...	Combretastatin ...	18 Years -	Mateon Therapeutics

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