A Single Center Study to Characterize the Absorption, Distribution, Metabolism and Excretion (ADME) of ASA404 After a Single Infusion in Patients With Solid Tumors

NCT01299701 | Terminated Phase 1

• 1 other identifier: CASA404A2108
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to characterize the absorption, distribution, metabolism and excretion (ADME) of ASA404 following a single intravenous administration of 3000 mg (approximately 1800 mg/m2) ASA404 containing 60 µCi of 14C over a period of 20 minutes in patients with advanced solid tumors. Metabolic pathways, route (s) of elimination, distribution characteristics in plasma and blood, and exposure characterization in plasma and blood, and exposure characterization of the parent drug and metabolites will be obtained from the study.

Conditions

Advanced Solid Tumors

Keywords

Advanced or metastatic cancer; refractory; core phase; extension phase; dose escalation; standard chemotherapy; docetaxel; paclitaxel; carboplatin; safety; tolerability

Outcome Measures

Primary Outcomes (1)

• characterize the pharmacokinetic profiles of ASA404 and any potential metabolite(s) in plasma and pharmacokinetic profiles of the total radioactivity in blood and plasma after a single intravenous infusion of 3000 mg [14C] ASA404 (60 µCi)

  12 months

Secondary Outcomes (3)

• determine the rate and routes of excretion of ASA404 (60 µCi)

  12 months

• identify metabolite(s) structures(s) and quantify the metabolites of ASA404 in plasma, urine, and feces in order to elucidate the biotransformation pathways and determine the essential clearance mechanisms of ASA404

  12 months

• collect safety data (including electrocardiograms) for ASA404

  12 months

Study Arms (1)

ASA404

EXPERIMENTAL

Drug: ASA404

Interventions

ASA404 DRUG

(5,6-dimethylxanthenone-4-acetic acid) DMXAA or DXAA

ASA404

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven diagnosis of advanced or metastatic solid tumors for whom either refractory to standard therapy exists, or for whom treatment with an investigational agent alone or in combination with docetaxel, paclitaxel, carboplatin, or paclitaxel plus carboplatin is appropriate;
• ANC≥ 1.5 x 109/L;
• Hgb ≥ 9.0 g/L;
• PLT ≥ 100,000/mm3;
• Total bilirubin ≤ 1.5;
• Willing and able to remain in the clinic for at least 4 days

You may not qualify if:

• Patients with CNS and/or leptomeningeal disease metastases allowed on the study unless asymptomatic and not requiring corticosteroid therapy. Patients having any clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS metastases in order to be eligible for study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed;
• Patients unable to undergo intravenous infusion;
• Patients with a Baseline 12-lead EGC QTc of \>450 msec;
• Radiotherapy in less than two (2) weeks prior to study entry;
• A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Grafton, Auckland, New Zealand

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

vadimezan

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis Pharmaceuticals

  Novartis Investigative

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 18, 2011
• Study Start: December 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

NZ (1)