Multi-arm, Non-randomized, Open-Label Phase IB Study to Evaluate GSK3052230 in Combination with Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects with Solid Malignancies and Deregulated FGF Pathway Signaling (FGF117360)

Multi-arm, Non-randomized, Open-Label Phase IB Study to Evaluate GSK3052230 in Combination with Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects with Solid Malignancies and Deregulated FGF Pathway Signaling (FGF117360) - FGF117360

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44632

Enrollment

Registered

2014-05-12

Start date

2014-09-11

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mesothelioma

Interventions

Treatment with GSK3052230.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Histologically or cytologically confirmed diagnosis: Arms A and B: Stage IV or recurrent metastatic squamous NSCLC with FGFR1 gene amplification. Arm A: No prior therapy for Stage IV or recurrent metastatic disease. Arm B: Documented tumor progression or intolerability after receiving only one prior line of platinum containing combination chemotherapy for Stage IV or recurrent metastatic disease. Arm C: recurrent after local therapy or unresectable mesothelioma with measurable lesions. No prior systemic therapy for mesothelioma. See protocol page 28 for further details.. • Availability of archival tumor tissue or fresh biopsy is required. Arms A and B, Prospective screening for FGFR1 gene amplification. • Measurable disease. • Male or female at least18 years. • Women of childbearing potential must agree to use effective contraception. See protocol page 29 for details. • Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception. See protocol page 29 for details. • ECOG Performance Status of 0-1 for Arm A and 0-2 for Arms B and C.

Exclusion criteria

Exclusion criteria: • For Arms A, B, C: Treatment with any FGFR inhibitor. For Arm B: Treatment with any anti-cancer therapy during the preceding 4 weeks or within 4 half-lives of the therapy. • Any biological therapy within 6 weeks of the first dose of GSK3052230. • Uncontrolled infection, major surgery or trauma within 28 days, any non-healing wound, fracture, or ulcer. • Any prohibited medication(s) as described on protocol page 78-79. • Conditions likely to increase the potential for abdominal perforation or fistula formation. See protocol page 30 for details. • Symptomatic leptomeningeal or brain metastases or spinal cord compression. See protocol page 30 for details. • Hemoptysis (>* teaspoon of red blood) 2 weeks prior to the first dose of GSK3052230. • Pregnant, lactating females.

Design outcomes

Primary

Measure	Time frame
Adverse events, MTD, overall survival.	—

Secondary

Measure	Time frame
PFS, population PK, Pulmonary Function Test parameters.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)