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Advanced Solid TumorsPhase 1NCT01529684

A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body

A Phase 1 study testing radio-labeled OSI-906 and OSI-906 in people with Advanced Solid Tumors and Pharmacokinetics of 14C-OSI-906, run by Astellas Pharma Global Development, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the Optional Treatment Phase. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
radio-labeled OSI-906 and OSI-906
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
2 sitesUnited States
Study dates
19 Mar 2012to 20 Feb 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

  • The subject has histologically or cytologically confirmed diagnosis of advanced solid tumor (measurable or non-measurable disease) for which no conventional therapy is available
  • The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
  • The subject has a predicted life expectancy ≥12 weeks
  • The subject has a fasting glucose ≤125 mg/dL (7 mmol/L) at Screening, Day -1 and pre-dose Day 1
  • The subject has adequate organ function defined by the following laboratory parameters:
  • absolute neutrophil count (ANC) ≥1.5 x 10 9/L
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  • platelet count ≥100 x 10 9/L
  • total bilirubin ≤1.5 x upper limit of normal (ULN)
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if subject has documented liver metastases
  • serum creatinine ≤1.5 x ULN
  • potassium, calcium, and magnesium within normal limits or determined by the investigator to be not clinically significant (NCS)
  • The subject has a negative cotinine test
  • If male, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method while participating in the study and for 90 days after the last dose of study medication
  • If female, the subject is surgically sterile or status post hysterectomy, post-menopausal, or is using 2 forms of medically acceptable methods of birth control, one of which must be a barrier method to prevent pregnancy and agrees to continue using this method from screening until 90 days after the last dose of study medication
  • If female, the subject must not be breastfeeding at Screening, during the study period and for 90 days after last dose of study drug administration
  • If female, the subject must not donate ova starting at Screening, and throughout the study period and for 90 days after last dose of study drug administration
  • Female subject of child bearing potential has a negative pregnancy test at Screening and Day -1

Who cannot join

  • The subject has Type 1 or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy
  • The subject has a history of poorly controlled gastrointestinal disorder (s) that could affect the absorption or metabolism of study drug
  • The subject has used IGF-1R inhibitor therapy in last 6 months
  • The subject has hepatocellular carcinoma
  • The subject has used a CYP1A2 inhibitor or inducer within 14 days prior to Day 1
  • The subject has used drugs with a risk of causing QTc interval prolongation and Torsade de Pointes (TdP) within 14 days prior to Day 1
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  • The subject has a history (within last 6 months) of significant cardio-vascular disease
  • The subject has a history (within the last 6 months) of significant arrhythmia disease, unless the disease is well-controlled with medication per the Principal Investigator's clinical judgment
  • The subject has had major surgery ≤ 3 weeks prior to Day 1
  • The subject has had radiation ≤ 3 weeks prior to Day 1
  • The subject has had chemotherapy ≤ 3 weeks prior to Day 1
  • The subject has participated in a radiolabeled study in the last 12 months
  • The subject has a history of cerebrovascular accident (CVA) within 6 months prior to Day 1 or that resulted in ongoing neurologic instability
  • The subject has an active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to Day 1) that would impair the ability of the subject to receive study drug
  • The subject has participated in any interventional clinical study within 21 days or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening
  • The subject has a history of any psychiatric condition that might impair the subject's ability to understand or to comply with the requirements of the study or to provide informed consent
  • The subject is pregnant or lactating
  • The subject has symptomatic brain metastases that are not stable, require steroids, or that have required radiation and/or other related treatment, (i.e., anti-epileptic medication) within 28 days prior to Day 1
  • The subject has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Comprehensive Clinical Development NW, Inc.

    Tacoma, Washington, 98418

Other trials in United States

About this study

Official title: A Phase 1, Open-label Study to Investigate the Absorption, Metabolism, and Excretion of 14C-OSI-906 in Subjects With Advanced Solid Tumors With an Optional Treatment Phase

The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the Optional Treatment Phase.

Read the detailed description

This study includes two parts: Part A

Subjects will be admitted to the clinical research unit on Day -1 and remain confined to the unit until post dosing discharge criteria are met up to a maximum of 10 days. On Day 1, subjects will receive a single oral dose of 14C-labeled OSI-906.

Part B (optional)

Once the subject has completed part A, the subject may elect to continue participation in Part B. Subjects will receive OSI-906 (non-radiolabeled) twice daily by mouth. Subjects will be seen for scheduled visits every 7 days for the first 36 days and then every 21 days.

Being tested
radio-labeled OSI-906, OSI-906
Keywords
oncology patients, Metabolic profile of 906, OSI-906, mass balance, Pharmacokinetics of 14C-OSI-906, Cancer, solid tumors, Absorption, Metabolism, and Excretion of OSI-906
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radio-labeled OSI-906Drug

    Part A: oral solution of 14C-OSI-906

  • OSI-906Drug

    Part B: oral tablets OSI-906

Study groups in NCT01529684
Study groupRoleWhat they receive
OSI-906ExperimentalTwo Parts: Part A: 14C-labeled OSI-906 Part B: (Optional) OSI-906 (non-labeled)
Receives: Drug: radio-labeled OSI-906; Drug: OSI-906

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radioactivity in whole blood and plasma

    Outcome measure for Part A: Area under the time concentration curve extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable time point (AUClast), Maximum Plasma Concentration (Cmax), Time to maximum concentration (Tmax), Terminal half-life (t 1/2), Apparent Body Clearance after dosing (CL/F), and Apparent volume of distribution (Vz/F)

    Measured: Up to 10 days from time of receipt of 14C-labeled OSI-906

  2. Radioactivity ratio in blood/plasma

    Outcome Measure for Part A of OSI-906 distribution between cellular components and plasma

    Measured: Up to 10 days from time of receipt of 14C-labeled OSI-906

  3. Excretion ratio and cumulative excretion of radioactivity in urine and feces

    Outcome measure for Part A

    Measured: Up to 10 days from time of receipt of 14C-labeled OSI-906

  4. Composite of Pharmacokinetics of OSI-906 in plasma: AUC inf, AUC last, C max, t max, t 1/2, CL/F, and Vz/F

    Outcome measure for Part A

    Measured: Up to 10 days from time of receipt of 14C-labeled OSI-906

  5. Composite of Pharmacokinetics of OSI-906 in urine: Cumulative amount of drug excreted into urine, feces or bile up to collection time of last measurable concentration (Ae last), Renal Clearance (CL R), and percentage of dose excreted (Ae last%)

    Outcome measure for Part A

    Measured: Up to 10 days from time of receipt of 14C-labeled OSI-906

Secondary outcomes (2)

  1. Metabolic Profile: Profiling of possible metabolites in OSI-906 plasma, urine, and feces

    Outcome measure for Part A

    Measured: Up to 10 days from time of receipt of 14C-labeled OSI-906

  2. Safety as assessed by recording adverse events, laboratory assessments and vital signs, and electrocardiograms (ECGs)

    Outcome measures for Part A and Part B

    Measured: For Part A: Days 1-10 and/or 30 days post treatment visit. For Part B: Treatment Period 1 (TP1) through 30 day post treatment visit (up to two years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2012 (estimated)
  2. Study start19 Mar 2012
  3. Primary completion8 Dec 2012
  4. Study completion20 Feb 2013

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01529684
Sponsor's protocol ID
OSI-906-104
Status last verified
Oct 2024
First submitted
7 Feb 2012
Last updated
7 Nov 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing radio-labeled OSI-906 and OSI-906 in people with Advanced Solid Tumors and Pharmacokinetics of 14C-OSI-906, run by Astellas Pharma Global Development, Inc. at 2 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 17 inclusion and 19 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 7 Nov 2024. 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 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 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?

Radioactivity in whole blood and plasma (time frame: Up to 10 days from time of receipt of 14C-labeled OSI-906). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01529684.

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 7 Nov 2024.

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Clinical Trial NCT01529684 | AzTrials