GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid Tumors

NCT01313598 | Completed Phase 1 DMC

• 2 other identifiers: GLPG0187-CL-1022010-021164-15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to determine the safety and tolerability of GLPG0187 administered through continuous intravenous infusion and to explore its preliminary clinical efficacy in patients with solid tumors.

Conditions

Solid Tumors

Keywords

Patients with solid tumors; Treatment-refractory

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Patients will be monitored for cardiovascular safety (ECG) and adverse events, and blood- and urine-samples taken before and at fixed timepoints after a one-hour infusion of GLPG0187; if patients tolerate the treatment well, procedures will be repeated before and at fixed timepoints after the start of a three-week continuous infusion patients. Through monitoring and analysis of the blood- and urine-samples, it will be established whether the study medication would have any negative effects on the patient's general condition. Results will indicate whether DLT has occurred.

  Four weeks + three-week cycles

Secondary Outcomes (3)

• Pharmacokinetics of GLPG0187 after intravenous infusion.

  Up to four weeks.

• Pharmacodynamics of GLPG0187

  Up to four weeks

• Preliminary efficacy of GLPG0187 in terms of clinical activity.

  Four weeks + three-week cycles

Study Arms (1)

GLPG0187

EXPERIMENTAL

GLPG0187 for infusion

Drug: GLPG0187

Interventions

GLPG0187 DRUG

continuous IV infusion

GLPG0187

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed diagnosis of advanced, recurrent, or metastatic cancer who are refractory to standard therapy or for whom no standard therapy exist.
• Age of 18 years or older.
• Measurable (according to RECIST 1.1) and evaluable disease as determined by the Investigator.
• ECOG Performance Status ≤ 2.
• Estimated life expectancy of at least 12 weeks.
• Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ Grade 2.
• Written informed consent according to local guidelines.

You may not qualify if:

• Prior Treatment:
• Less than 4 weeks since the last treatment with other cancer therapies, (i.e. endocrine therapy, immunotherapy, chemotherapy, etc.), and \< 6 weeks for nitrosoureas and Mitomycin C.
• Prior therapy with integrin receptor antagonists
• Current Treatment:
• Chronic daily treatment with corticosteroids (dose of 10 mg/day or more methylprednisolone or equivalent), with the exception of inhaled steroids.
• Current or recent (within 30 days of first study treatment) treatment with another investigational drug or participation in another investigational study.
• Hematology, coagulation and biochemistry:
• Inadequate bone marrow function: Absolute Neutrophil Count (ANC): \< 1.5 x 10E9/L, or platelet count \<100 x 10E9/L or hemoglobin \< 6 mmol/L.
• Inadequate liver function, defined as:
• Serum (total) bilirubin \> 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).
• Inadequate renal function, defined as:
• Serum creatinine \> 1.5 x ULN
• Urine dipstick for proteinuria \> 2+.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (2)

Nationaal Kanker Instituut (NKI)

Amsterdam, 1066 CX, Netherlands

Location

Universitair Medisch Centrum

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Interventions

GLPG0187

Study Officials

• Giocondo Lorenzon, MSc

  Galapagos SASU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 14, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

NL (2)