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Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated Fibroblast Growth Factor (FGF) Pathway Signaling

NCT01868022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-08-19

Study results available
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Summary

This phase IB trial aims to identify anticancer activity of GSK3052230 in subjects with malignancies with abnormal dependence on FGF pathway signaling. Combination doses of GSK3052230 with standard of care chemotherapy in the first and second line or greater setting of metastatic squamous non-small cell lung cancer (NSCLC) and first line malignant pleural mesothelioma subjects will be studied in the 3+3 dose-escalation design. This will be a multi-arm, multicenter, non-randomized, parallel-group, uncontrolled, open-label Phase IB study designed to evaluate the safety, tolerability and preliminary activity of GSK3052230 in combination with paclitaxel + carboplatin (Arm A), in combination with docetaxel (Arm B), or in combination with pemetrexed + cisplatin (Arm C). Approximately 70 subjects will be enrolled in the study (approximately up to 120 may be enrolled).

Conditions

  • Neoplasms

Interventions

DRUG

GSK3052230

A clear to opalescent, colorless to pale yellow solution for IV infusion once weekly (Day 1, Day 8, Day 15) in each 21-day cycle with unit dose strengths/dose level of 5, 10, 15, and 20 mg/kg supplied in a sterile 25 mL glass vial.

DRUG

paclitaxel

paclitaxel will be from commercial stock.

DRUG

carboplatin

carboplatin will be from commercial stock.

DRUG

docetaxel

docetaxel will be from commercial stock.

DRUG

pemetrexed

pemetrexed will be from commercial stock

DRUG

cisplatin

cisplatin will be from commercial stock

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-09
Primary Completion
2017-10-24
Completion
2017-10-24
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • Netherlands
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01868022 on ClinicalTrials.gov