An open-label, dose escalating Phase Ib study for the assessment of safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple intravenous doses of GLPG0187 in subjects with solid tumors.

An open-label, dose escalating Phase Ib study for the assessment of safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple intravenous doses of GLPG0187 in subjects with solid tumors. - Phase Ib study with GLPG0187 in subjects with solid tumors.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36388

Enrollment

Registered

2010-12-24

Start date

2011-03-22

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

solid neoplasm solid tumors

Interventions

Subjects eligible for the study will be assigned to a dose level cohort. Subjects in the first dose level cohort will receive the starting dose of 20 mg/day. The sequential dose escalations incremen

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed diagnosis of advanced, recurrent, or metastatic cancer who are refractory to standard therapy or for whom no standard therapy exist. 2. Age >= 18 years. 3. Measurable (according to RECIST 1.1) and evaluable disease as determined by the Investigator. 4. ECOG Performance Status

Exclusion criteria

Exclusion criteria: Prior Treatment: 1. Less than 4 weeks since the last treatment with other cancer therapies, (i.e. endocrine therapy, immunotherapy, chemotherapy, etc.), and 2 x the Upper Limit of Normal (ULN) for the institution; • Aspartate Amino Transferase (ASAT) or Alanine Amino Transferase (ALAT) > 2.5 x ULN (> 5 x ULN in subjects with liver metastases); • Alkaline phosphatase levels > 2.5 x ULN (> 5 x ULN in subjects with liver metastases, or > 10 x ULN in subjects with bone metastases). 7. Inadequate renal function, defined as: • Serum creatinine > 1.5 x ULN • Urine dipstick for proteinuria > 2+.;Other: 8. Clinically symptomatic or progressive brain metastases 9. Clinical Leptomeningeal metastases 10. Pregnancy or lactation. Urine pregnancy test to be assessed within 7 days prior to study treatment start. 11. For women of childbearing potential (defined as

Design outcomes

Primary

Measure	Time frame
The incidence rate of DLTs at each dose level based on the following safety parameters: Adverse drug reactions (ADR) and serious ADRs, changes in hematology and chemistry values, including those associated with hepatic and renal function, and assessment of physical examinations, vital signs and cardiac function (i.e. repeated electrocardiograms). NCI-CTCAE version 4.03 will be used.	—

Secondary

Measure	Time frame
• Exposure to GLPG0187 in plasma; • Effects of GLPG0187 on bone resorption biomarker; • Preliminary efficacy: Antitumor effects of GLPG0187 according to RECIST 1.1.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)