NB1011 Administered by Continuous Infusion in Cancers That Overexpress Thymidylate Synthase (TS)

Kiadis Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Tumors

Treatments: Drug: NB1011

Study type: Interventional

Funder types: Industry

Identifiers

NCT00248404

CR-TSC-001

Details and patient eligibility

About

The purpose of this trial is to assess the tolerability and safety of NB1011 in the treatment of patients with cancers that overexpress TS, such as ovarian, gastrointestinal, colorectal, bladder, breast, and lung cancers.

Enrollment: 155 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced, recurrent, or metastatic solid tumors
• TS overexpression (> 4 by reverse transcription polymerase chain reaction [RT-PCR]) in archival and fresh samples
• Suitable for experimental monotherapy
• Measurable disease

Exclusion criteria

• Tumors that cannot be biopsied or with low level of TS expression
• Requirement for concomitant anticancer therapy
• Treatment with another investigational product within 30 days of study entry
• Pregnant or lactating women
• Active or uncontrolled serious bacterial, viral, fungal, or parasitic infection.
• HIV infection
• Clinically apparent meningeal or central nervous system (CNS) metastases or carcinomatous meningitis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)