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Safety Study of Sterile Compound C31510 for Injection to Subjects With Solid Tumors

NCT01251562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-02-19

No results posted yet for this study

Summary

The primary objective of this clinical study is as follows:

• To determine the MTD and to assess the safety and tolerability of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors

The secondary objective of this study is as follows:

• To evaluate plasma PK and estimate renal elimination of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors

The exploratory objectives of this study are as follows:

* To evaluate the pharmacodynamic correlates of C31510 activity in plasma and peripheral blood cells
* To radiographically evaluate the effects of C31510 on tumors. In selected subjects, the effects on vascular permeability will be assessed by digital contrast enhanced (DCE)-magnetic resonance imaging (MRI)
* To evaluate tumor response (preliminary antitumor activity) after repeat administration of C31510
* Long-term safety and tolerability of C31510 after repeat administration

Conditions

Interventions

DRUG

Sterile Compound C31510 for Injection

During the treatment period, subjects in each initial dose level cohort will have a single 4-hour IV infusion of C31510 at the assigned dose level of their particular cohort, three times per week for 26 days (on Day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26) followed by a 28-day follow up period that will be counted from the first dose given on Day 1. In the absence of unacceptable toxicity or disease progression during the treatment period, those subjects may receive similar 28-day repeat treatment cycles of 3 times per week for up to 1 year, at the discretion of the investigator.

Sponsors & Collaborators

  • BPGbio

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-08-31
Completion
2014-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01251562 on ClinicalTrials.gov