Solid TumorsPhase 4NCT00944372
Study to Evaluate the Effect of Age (Geriatric) and Kidney Function on the Safety, Efficacy and Pharmacokinetics of OctreoScan in Patients Who Have New or Recurrent Tumors
A Phase 4 study testing Indium In-111 pentetreotide in people with Solid Tumors, run by Mallinckrodt at 4 sites in United States.
Trial summary
The objective of this study was to evaluate the effect of age (geriatric) and renal function on the safety, efficacy and pharmacokinetics of OctreoScan at the recommended clinical dose in this patient population. 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?
- Indium In-111 pentetreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2003to Aug 2005
- Phase
- Phase 4
- 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
- Males or females 18 years of age and older.
- If female and of childbearing potential, patients must have a negative pregnancy test within 24 hours of study drug administration. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study.
- If deemed necessary by the Principal Investigator, patients entering the pharmacokinetic population must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration.
- Patients (when able) or legally authorized representatives must have the ability to understand the requirements of the study and provide written consent to participate and agree to abide by the study requirements.
- Patients must have tumor localization by conventional imaging methods prior to enrollment (i.e., CT, MRI, US, angiogram).
- Patients referred for scintigraphy of solid tumors with a high suspicion of containing somatostatin receptor positive tissue.
- Patients with first-time tumors must be scheduled for a tissue biopsy. A tissue sample will be sent to the core laboratory for conventional histology and immunohistochemistry analysis.
- Patients with recurrent tumors or progressive tumors must have previous biopsy results documented, with previous biopsy tissue obtainable for immunohistochemistry analysis.
Who cannot join
- Patients receiving Sandostatin LAR < 21 days prior to dosing or Sandostatin Immediate Release (IM) < 24 hours prior to dosing.
- Patients who have received any investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period (patients on a research protocol using an approved drug are accepted).
- Patients who are pregnant, breastfeeding or lactating.
- Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
- Patients scheduled to undergo any scintigraphy within 7 days prior to study participation or PET scanning within 24 hours prior to study participation.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Iowa Medical Center
Iowa City, Iowa, 52242
University of Miami, Jackson Memorial Hospital
Miami, Florida, 33136
Louisiana State University, Division of Hem/Onc
New Orleans, Louisiana, 70112
Hospital of University of Pennsylvania, Division of Nuclear Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: An Open-Label, Multi-Center, Phase 4 Study to Evaluate the Effect of Age (Geriatric) and Renal Function on the Safety, Efficacy (Sensitivity, Specificity) and Pharmacokinetics of OctreoScan in Patients Referred for Scintigraphy of All Solid Tumors With a High Suspicion of Containing Somatostatin Receptor Positive Tissue
The objective of this study was to evaluate the effect of age (geriatric) and renal function on the safety, efficacy and pharmacokinetics of OctreoScan at the recommended clinical dose in this patient population.
- Conditions
- Solid Tumors
- Being tested
- Indium In-111 pentetreotide
- Keywords
- Tumor, somatostatin receptor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indium In-111 pentetreotideDrug
Also called OctreoScan, In-111
Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Control, age greater than or equal to 18 with normal renal function Receives: Drug: Indium In-111 pentetreotide |
| Group 2 | Experimental | Age 18 to less than 65 with mild renal impairment Receives: Drug: Indium In-111 pentetreotide |
| Group 3 | Experimental | Age 18 to less than 65 with moderate to severe renal impairment Receives: Drug: Indium In-111 pentetreotide |
| Group 4 | Experimental | Age 18 to less than 65 with end stage renal impairment Receives: Drug: Indium In-111 pentetreotide |
| Group 5 | Experimental | Age 65 to less than 75 with mild renal impairment Receives: Drug: Indium In-111 pentetreotide |
| Group 6 | Experimental | Age 65 to less than 75 with moderate to severe renal impairment Receives: Drug: Indium In-111 pentetreotide |
| Group 7 | Experimental | Age 65 to less than 75 with end stage renal impairment Receives: Drug: Indium In-111 pentetreotide |
| Group 8 | Experimental | Age greater than or equal to 75 with mild renal impairment Receives: Drug: Indium In-111 pentetreotide |
| Group 9 | Experimental | Age greater than or equal to 75 with moderate to severe renal impairment Receives: Drug: Indium In-111 pentetreotide |
| Group 10 | Experimental | Age greater than or equal to 75 with end stage renal impairment Receives: Drug: Indium In-111 pentetreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis
Measured: Through 24 hours post dose
Secondary outcomes (1)
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive using previously biopsied tissue for immunohistochemistry analysis
Measured: Through 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2003
- Primary completionAug 2005
- Study completionAug 2005
Why it stopped: Enrollment was difficult
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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944372
- Sponsor's protocol ID
- 0050-02-763
- Status last verified
- Sep 2016
- First submitted
- 21 Jul 2009
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Phase 4 Study to Evaluate the Effect of Age (Geriatric) and Renal Function on the Safety, Efficacy (Sensitivity, Specificity) and Pharmacokinetics of OctreoScan in Patients Referred for Scintigraphy of All Solid Tumors With a High Suspicion of Containing Somatostatin Receptor Positive Tissue
- ClinicalTrials.gov ID
- NCT00944372
- Acronym / sponsor ID
- 0050-02-763
- Conditions
- Solid Tumors
- Keywords
- Tumor, somatostatin receptor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was difficult
- Enrolment
- 150 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 23 Jul 2009 (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 objective of this study was to evaluate the effect of age (geriatric) and renal function on the safety, efficacy and pharmacokinetics of OctreoScan at the recommended clinical dose in this patient population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Indium In-111 pentetreotideControl, age greater than or equal to 18 with normal renal function |
| Group 2 | Experimental | Drug: Indium In-111 pentetreotideAge 18 to less than 65 with mild renal impairment |
| Group 3 | Experimental | Drug: Indium In-111 pentetreotideAge 18 to less than 65 with moderate to severe renal impairment |
| Group 4 | Experimental | Drug: Indium In-111 pentetreotideAge 18 to less than 65 with end stage renal impairment |
| Group 5 | Experimental | Drug: Indium In-111 pentetreotideAge 65 to less than 75 with mild renal impairment |
| Group 6 | Experimental | Drug: Indium In-111 pentetreotideAge 65 to less than 75 with moderate to severe renal impairment |
| Group 7 | Experimental | Drug: Indium In-111 pentetreotideAge 65 to less than 75 with end stage renal impairment |
| Group 8 | Experimental | Drug: Indium In-111 pentetreotideAge greater than or equal to 75 with mild renal impairment |
| Group 9 | Experimental | Drug: Indium In-111 pentetreotideAge greater than or equal to 75 with moderate to severe renal impairment |
| Group 10 | Experimental | Drug: Indium In-111 pentetreotideAge greater than or equal to 75 with end stage renal impairment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females 18 years of age and older.
- If female and of childbearing potential, patients must have a negative pregnancy test within 24 hours of study drug administration. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study.
- If deemed necessary by the Principal Investigator, patients entering the pharmacokinetic population must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration.
- Patients (when able) or legally authorized representatives must have the ability to understand the requirements of the study and provide written consent to participate and agree to abide by the study requirements.
- Patients must have tumor localization by conventional imaging methods prior to enrollment (i.e., CT, MRI, US, angiogram).
Key exclusion criteria (5 listed)
- Patients receiving Sandostatin LAR < 21 days prior to dosing or Sandostatin Immediate Release (IM) < 24 hours prior to dosing.
- Patients who have received any investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period (patients on a research protocol using an approved drug are accepted).
- Patients who are pregnant, breastfeeding or lactating.
- Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
- Patients scheduled to undergo any scintigraphy within 7 days prior to study participation or PET scanning within 24 hours prior to study participation.
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 |
|---|---|---|
| Indium In-111 pentetreotideAlso: OctreoScan, In-111Single intravenous injection of 222MBq (6.0 mCi) Indium In-111 pentetreotide | Drug | Group 1, Group 10, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7, Group 8, Group 9 |
Primary outcome
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis
Time frame: Through 24 hours post dose
1 secondary outcome
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive using previously biopsied tissue for immunohistochemistry analysis
Time frame: Through 24 hours post dose
Results and safety
The study was stopped early (reason given: Enrollment was difficult). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indium In-111 pentetreotide in people with Solid Tumors, run by Mallinckrodt at 4 sites in United States.
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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Enrollment was difficult). Results are not available in the source record.
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?
Assessment of OctreoScan diagnostic sensitivity for detecting tumor(s) confirmed as somatostatin receptor positive by biopsy with immunohistochemistry analysis (time frame: Through 24 hours post dose). 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 9 Sep 2016.