NCT01240642

Brief Summary

The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 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

January 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

December 9, 2020

Status Verified

November 1, 2012

Enrollment Period

11 months

First QC Date

November 11, 2010

Last Update Submit

December 6, 2020

Conditions

Metastatic Cancer With Impaired Renal FunctionMetastatic Cancer With Normal Renal Function

Keywords

Advanced or metastatic cancerrefractorycore phaseextension phasedose escalationstandard chemotherapydoctaxelpaclitaxelcarboplatinsafetytolerability

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 monnths

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)

    12 months

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

    12 months

  • To evaluate renal clearance (CLR) of ASA404.

    12 months

Study Arms (1)

ASA404

EXPERIMENTAL
Drug: ASA404

Interventions

ASA404DRUG
ASA404

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)

Novartis Investigative Site

Charleroi, Belgium

Location

Novartis Investigative Site

Jette, Belgium

Location

Novartis Investigative Site

Saint-Lambert, Belgium

Location

Novartis Investigative Site

Wilrijk, Belgium

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 Pharmaceuticals

    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

November 11, 2010

First Posted

November 15, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Last Updated

December 9, 2020

Record last verified: 2012-11

Locations

BE(4)