NCT01278758

Brief Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in patients with refractory or relapsed metastatic cancer with impaired renal function and with normal renal function. It is very possible that patients with renal impairment will show differences in renal excretion of parent ASA404 and its metabolites, warranting a study that leads to a better pharmacokinetic assesssment in this population.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
Last Updated

December 9, 2020

Status Verified

November 1, 2012

Enrollment Period

8 months

First QC Date

January 16, 2011

Last Update Submit

December 6, 2020

Conditions

Metastatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • To evaluate the pK of a single intravenous dose of ASA404 1200 and 1800 mg/m2 monotherapy in adult cancer patients with impaired renal function compared to matching patients with normal renal function

    12 months

Secondary Outcomes (5)

  • To evaluate the pharmacokinetics of a single i.v. dose of ASA 1200 and 1800 mg/m2 +chemotherapy (doctaxel or paclitaxel + carboplatin) in adult cancer patients with impaired renal function compared to matching patients with normal renal function

    12 months

  • To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function

    12 months

  • To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin)

  • To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax

  • To evaluate renal clearance (CLR) of ASA404.

Study Arms (1)

ASA404 + standard therpy

EXPERIMENTAL
Drug: ASA404, DMXAA or DXAA

Interventions

ASA404, DMXAA or DXAADRUG
ASA404 + standard therpy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having histologically-proven solid tumors, who are either refractory to standard chemotherapy;
  • Patients whom chemotherapy with an investigaional agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate;
  • Creatinine clearance according to Cockcroft-Gault formula : Normal \> 80 mL/min, Mild 50-80 mL/min, Moderate 30-\<50 mL/min;
  • A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies;
  • Potassium, calcium, magnesium and phosphorus values within the normal range;
  • Body Mass Index (BMI) must be within the range of 18 and 30

You may not qualify if:

  • Patients having CNS metastases, must have a CT or MRI of the brain performed to rule out CNS metastases;
  • Patients with leptomeningeal disease metastases;
  • Radiotherapy \</- weeks prior to starting study drug;
  • Major surgery \</ 4 weeks prior to the start of study;
  • Administration of CYP1A2 and CYP3A4/5 enzyme inducing or inhibiting drugs within 14 days prior to starting study drug;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept.

Indianapolis, Indiana, 46202, United States

Location

Hematology /Oncology Associates

Rockville, Maryland, 20850, United States

Location

Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

vadimezan

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Investigative Site

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2011

First Posted

January 19, 2011

Study Start

March 1, 2010

Primary Completion

November 1, 2010

Last Updated

December 9, 2020

Record last verified: 2012-11

Locations

US(4)