NeoplasmsPhase 1NCT02442063
Phase Ib Study of Radium Ra 223 Dichloride in Combination With Paclitaxel in Cancer Subjects With Bone Lesions
A Phase 1 study testing Radium Ra 223 dichloride (Xofigo, BAY88-8223) and paclitaxel in people with Neoplasms and Bone Diseases, run by Bayer at 5 sites in 3 countries.
Trial summary
This phase Ib combination study is being conducted to assess the safety and tolerability of radium Ra 223 dichloride in combination with paclitaxel in cancer subjects with bone lesions with special focus on Grade 3/4 incidence of neutro- and/or thrombocytopenia and exploration of the mode of interaction (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Bone Diseases
- What is being tested?
- Radium Ra 223 dichloride (Xofigo, BAY88-8223) and paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Aug 2015to Oct 2016
- 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
- Male or female patients ≥ 18 years of age
- Subjects diagnosed with histologically or cytologically confirmed malignant solid tumors and at least two according bone lesions. A standard of practice bone scan for the documentation of at least 2 bone lesions can be used as long as it is within 3 months of planned start of treatment. If no bone scan within a 3 month window is available, then technetium 99m or NaF PET bone scan will be obtained at screening (within 28 days of planned start of study drug)
- Eligible to treatment with paclitaxel as single agent, following the assessment of the investigator. If treatment with paclitaxel has already been initiated before signing the informed consent, patients will not be eligible.
- For women: documentation of menopausal status: pre menopausal or post menopausal subjects. Post menopausal status is defined either by: one year or more of amenorrhea in the absence of other biological or physiological causes, or surgical menopause with bilateral oophorectomy.
- Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and for 6 months after the last radium Ra 223 dichloride administration. These procedures should be documented in source documents, the investigator or a designated associate is requested to advise the subject on how to achieve birth control.
- Women of childbearing potential must have a serum pregnancy test performed within 7 days before start of study treatment, and a negative result must be documented before start of study treatment
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- Life expectancy of at least 16 weeks
- Adequate bone marrow function assessed within 7 days of starting the study treatment, judged by the following laboratory values:
- Platelet count ≥ 100.000/cubic millimeters (mm3), within 7 days of starting the study treatment AND
- Hemoglobin (HB) ≥ 9.0g/dl, within 7 days of starting the study treatment AND
- Absolute neutrophil count (ANC) ≥ 1500/mm3 within 7 days of starting the study treatment
- Adequate liver function assessed within 7 days of starting the study treatment, judged by the following laboratory values:
- Total bilirubin ≤ 1.5 x the upper limit of normal range (ULN) (except for subjects with documented Gilbert's disease) AND
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤5 x ULN for subjects whose cancer involves their liver including liver metastasis) within 7 days of starting the study treatment AND
- Albumin > 30 g/L within 7 days of starting the study treatment
- International normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant, e.g. heparin, will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists and INR of the patient is < 3. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care If patients are on newer generation therapeutic blood thinning agents without the requirement of monitoring (e.g. Xarelto, Dabigatran), patients are eligible and management (e.g. discontinuation of the anticoagulant) will be handled by good medical practice standards under direction of the investigator
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Estimated creatinine clearance (CLCr) ≥ 30 mL/min as calculated using the Cockcroft-Gault equation
Who cannot join
- History of other malignancy which could affect compliance with the protocol or interpretation of results.
- Received systemic therapy with radionuclides (e.g., strontium 89, samarium 153, rhenium 186, rhenium 188 or radium 223), including radium Ra 223 dichloride, for the treatment of bone metastases
- Previous (within 4 weeks prior to first treatment within this study) or concomitant participation in another clinical study with investigational medicinal product(s)
- Imminent or established spinal cord compression based on clinical findings and/or MRI.
- Active brain metastases or meningeal tumors if the subject is < 2 months from definitive therapy, has evidence of tumor growth on an imaging study within 4 weeks prior to study entry and is on dexamethasone and not clinically stable with respect to the tumor at the time of study entry.
- Prior hemibody external radiotherapy
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- Bone fracture in weight bearing bones without acceptable orthopedic stabilization within 4 weeks prior to start of treatment
- Confirmed Paget's disease of the bone
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) or pulmonary embolism within 6 months before the start of study medication or deep vein thrombosis within 3 months before the start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication)
- Subjects with evidence or history of bleeding diathesis; any hemorrhage or bleeding event CTCAE Grade ≥ 3 or higher within 4 weeks of start of investigational treatment
- History of Bone marrow dysplasia
- Pregnancy and lactation (breast feeding)
- Evidence of peripheral neuropathy > grade 1
- Blood transfusion or use of erythropoietin within 6 weeks prior to start of study treatment (chemotherapy). Platelet transfusions are not allowed within 3 weeks prior to start of study treatment (chemotherapy). Use of biologic response modifies, such as granulocyte macrophage-colony-stimulating factor (GM-CSF or granulocyte-colony-stimulating factor (G-CSF), within 6 weeks prior to start of study treatment (chemotherapy).
- Intake of clozapine within 4 weeks before start of study treatment.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom2 sites
Study site
Sheffield, S10 2SJ
Study site
Sutton, Surrey, SM2 5PT
About this study
Official title: An Open-label, Multi-center, Non-randomized Phase Ib Study to Investigate Safety and Tolerability of Radium Ra 223 Dichloride (BAY88-8223) Administered in Combination With Paclitaxel in Cancer Subjects With Bone Lesions
This phase Ib combination study is being conducted to assess the safety and tolerability of radium Ra 223 dichloride in combination with paclitaxel in cancer subjects with bone lesions with special focus on Grade 3/4 incidence of neutro- and/or thrombocytopenia and exploration of the mode of interaction (i.e. additive or synergistic interaction) between the selected chemotherapy and radium Ra 223 dichloride with regard to myelosuppression.
- Conditions
- Neoplasms, Bone Diseases
- Being tested
- Radium Ra 223 dichloride (Xofigo, BAY88-8223), paclitaxel
- Medical subject headings
- Neoplasms, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium Ra 223 dichloride (Xofigo, BAY88-8223)Drug
50 kBq/kg intravenous injection once every 4 weeks, will be administrated from cycle 2 up to 6 cycles
paclitaxelDrug
90 mg/m2 intravenous injection per week in a 3-week-on / 1-week-off regimen, will be administered as per local standard of care, starting in cycle 1
| Study group | Role | What they receive |
|---|---|---|
| Radium Ra 223 dichloride | Experimental | Radium Ra 223 dichloride (Xofigo, BAY88-8223) Receives: Drug: Radium Ra 223 dichloride (Xofigo, BAY88-8223); Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants with thrombocytopenia during cycle 1 (paclitaxel alone), 2 and 3 (combination treatment)
Measured: Approximately 12 weeks
The percentage of participants with neutropenia during cycle 1 (paclitaxel alone), 2 and 3 (combination treatment)
Measured: Approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442063
- Sponsor's protocol ID
- 17110
- Other IDs
- 2015-000083-34, 2015
- Status last verified
- Nov 2016
- First submitted
- 4 May 2015
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Non-randomized Phase Ib Study to Investigate Safety and Tolerability of Radium Ra 223 Dichloride (BAY88-8223) Administered in Combination With Paclitaxel in Cancer Subjects With Bone Lesions
- ClinicalTrials.gov ID
- NCT02442063
- Acronym / sponsor ID
- 17110
- Conditions
- Neoplasms, Bone Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 May 2015 (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.
This phase Ib combination study is being conducted to assess the safety and tolerability of radium Ra 223 dichloride in combination with paclitaxel in cancer subjects with bone lesions with special focus on Grade 3/4 incidence of neutro- and/or thrombocytopenia and exploration of the mode of interaction (i.e. additive or synergistic interaction) between the selected chemotherapy and radium Ra 223 dichloride with regard to myelosuppression.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium Ra 223 dichloride | Experimental | Drug: Radium Ra 223 dichloride (Xofigo, BAY88-8223), Drug: paclitaxelRadium Ra 223 dichloride (Xofigo, BAY88-8223) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female patients ≥ 18 years of age
- Subjects diagnosed with histologically or cytologically confirmed malignant solid tumors and at least two according bone lesions. A standard of practice bone scan for the documentation of at least 2 bone lesions can be used as long as it is within 3 months of planned start of treatment. If no bone scan within a 3 month window is available, then technetium 99m or NaF PET bone scan will be obtained at screening (within 28 days of planned start of study drug)
- Eligible to treatment with paclitaxel as single agent, following the assessment of the investigator. If treatment with paclitaxel has already been initiated before signing the informed consent, patients will not be eligible.
- For women: documentation of menopausal status: pre menopausal or post menopausal subjects. Post menopausal status is defined either by: one year or more of amenorrhea in the absence of other biological or physiological causes, or surgical menopause with bilateral oophorectomy.
- Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and for 6 months after the last radium Ra 223 dichloride administration. These procedures should be documented in source documents, the investigator or a designated associate is requested to advise the subject on how to achieve birth control.
Key exclusion criteria (15 listed)
- History of other malignancy which could affect compliance with the protocol or interpretation of results.
- Received systemic therapy with radionuclides (e.g., strontium 89, samarium 153, rhenium 186, rhenium 188 or radium 223), including radium Ra 223 dichloride, for the treatment of bone metastases
- Previous (within 4 weeks prior to first treatment within this study) or concomitant participation in another clinical study with investigational medicinal product(s)
- Imminent or established spinal cord compression based on clinical findings and/or MRI.
- Active brain metastases or meningeal tumors if the subject is < 2 months from definitive therapy, has evidence of tumor growth on an imaging study within 4 weeks prior to study entry and is on dexamethasone and not clinically stable with respect to the tumor at the time of study entry.
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 |
|---|---|---|
| Radium Ra 223 dichloride (Xofigo, BAY88-8223)50 kBq/kg intravenous injection once every 4 weeks, will be administrated from cycle 2 up to 6 cycles | Drug | Radium Ra 223 dichloride |
| paclitaxel90 mg/m2 intravenous injection per week in a 3-week-on / 1-week-off regimen, will be administered as per local standard of care, starting in cycle 1 | Drug | Radium Ra 223 dichloride |
Primary outcome
The percentage of participants with thrombocytopenia during cycle 1 (paclitaxel alone), 2 and 3 (combination treatment)
Time frame: Approximately 12 weeks
The percentage of participants with neutropenia during cycle 1 (paclitaxel alone), 2 and 3 (combination treatment)
Time frame: Approximately 12 weeks
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 30 Nov 2016.
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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.
Bayer Study Director study director
Bayer
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radium Ra 223 dichloride (Xofigo, BAY88-8223) and paclitaxel in people with Neoplasms and Bone Diseases, run by Bayer at 5 sites in 3 countries.
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 18 inclusion and 15 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 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel, United Kingdom, Finland. 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?
The percentage of participants with thrombocytopenia during cycle 1 (paclitaxel alone), 2 and 3 (combination treatment) (time frame: Approximately 12 weeks). The study lists 2 primary outcomes in all. 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 30 Nov 2016.