Solid TumorsPhase 1NCT01313598
GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid Tumors
A Phase 1 study testing GLPG0187 in people with Solid Tumors, run by Lakefront Biotherapeutics NV at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- GLPG0187
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- Mar 2011to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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+.
- Other:
- Clinically symptomatic or progressive brain metastases
- Clinical Leptomeningeal metastases
- Pregnancy or lactation. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.
- For women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile): absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel).
- Major surgical procedure (including open biopsy, excluding central line IV and portacath) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
- Congestive heart failure NYHA Class III and IV. Cardiac arrhythmias (except for atrioventricular block type I, Mobitz type, and II, Wenckebach type) signs and symptoms of relevant cardiovascular disease.
- Known hypersensitivity to any of the study drugs or excipients.
- Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, physical examination or laboratory findings) that may interfere with the planned treatment, affect subject compliance or place the subject at high risk from treatment-related complications.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Nationaal Kanker Instituut (NKI)
Amsterdam, 1066 CX
Universitair Medisch Centrum
Utrecht, 3584 CX
About this study
Official title: 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
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.
Read the detailed description
Patients with pathologically confirmed diagnosis of advanced, recurrent, or metastatic cancer and who are refractory to standard therapy or for whom no standard therapy exists will first receive a one-hour infusion of a defined dose of GLPG0187. If well tolerated, one week later a three-week continuous infusion is started. If according to the investigator a subject has a clinical benefit from treatment with GLPG0187, the treatment cycle may be repeated until disease progression, Dose Limiting Toxicity (DLT), or the patient chooses to stop or cannot/will not comply with study procedures.
Throughout treatment, safety and tolerability will be monitored. Within one patient, a fixed dose (infusion rate) will be used. If at a given dose-level sufficient patients have been treated without reaching DLT, the dose for the next group of patients will be increased. This can be repeated until DLT is established, or the scheduled maximum dosage is reached.
- Conditions
- Solid Tumors
- Being tested
- GLPG0187
- Keywords
- Patients with solid tumors, Treatment-refractory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0187Drug
continuous IV infusion
| Study group | Role | What they receive |
|---|---|---|
| GLPG0187 | Experimental | GLPG0187 for infusion Receives: Drug: GLPG0187 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks + three-week cycles
Secondary outcomes (3)
Pharmacokinetics of GLPG0187 after intravenous infusion.
Blood samples will be taken at regular timepoints before and on fixed timepoints after start of the one-hour infusion, as well as before and on fixed timepoints during the (first) three-week infusion, to establish the concentration of the study medication in the blood.
Measured: Up to four weeks.
Pharmacodynamics of GLPG0187
Blood samples will be taken at regular timepoints before and on fixed timepoints after start of the one-hour infusion, as well as before and on fixed timepoints during the (first) three-week infusion, to measure the levels of CTx (collagen telopeptide, a bone resorption biomarker).
Measured: Up to four weeks
Preliminary efficacy of GLPG0187 in terms of clinical activity.
evaluation of antitumor effects according to RECIST 1.1.
Measured: Four weeks + three-week cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giocondo Lorenzon, MSc, Study director, Galapagos SASU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313598
- Sponsor's protocol ID
- GLPG0187-CL-102
- Other IDs
- 2010-021164-15
- Status last verified
- Jun 2013
- First submitted
- 28 Feb 2011
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01313598
- Acronym / sponsor ID
- GLPG0187-CL-102
- Conditions
- Solid Tumors
- Keywords
- Patients with solid tumors, Treatment-refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with pathologically confirmed diagnosis of advanced, recurrent, or metastatic cancer and who are refractory to standard therapy or for whom no standard therapy exists will first receive a one-hour infusion of a defined dose of GLPG0187. If well tolerated, one week later a three-week continuous infusion is started. If according to the investigator a subject has a clinical benefit from treatment with GLPG0187, the treatment cycle may be repeated until disease progression, Dose Limiting Toxicity (DLT), or the patient chooses to stop or cannot/will not comply with study procedures.
Throughout treatment, safety and tolerability will be monitored. Within one patient, a fixed dose (infusion rate) will be used. If at a given dose-level sufficient patients have been treated without reaching DLT, the dose for the next group of patients will be increased. This can be repeated until DLT is established, or the scheduled maximum dosage is reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLPG0187 | Experimental | Drug: GLPG0187GLPG0187 for infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (24 listed)
- Prior Treatment:
- Current Treatment:
- Hematology, coagulation and biochemistry:
- Other:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLPG0187continuous IV infusion | Drug | GLPG0187 |
Primary outcome
Safety and tolerability
Time frame: Four weeks + three-week cycles
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.
3 secondary outcomes
Pharmacokinetics of GLPG0187 after intravenous infusion.
Time frame: Up to four weeks.
Pharmacodynamics of GLPG0187
Time frame: Up to four weeks
Preliminary efficacy of GLPG0187 in terms of clinical activity.
Time frame: Four weeks + three-week cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giocondo Lorenzon, MSc study director
Galapagos SASU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLPG0187 in people with Solid Tumors, run by Lakefront Biotherapeutics NV at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Four weeks + three-week cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2013.