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Unspecified Adult Solid Tumor, Protocol SpecificCPCT-03NCT01566279

A Study to Identify a Biomarker Predictive for Response on Everolimus in Solid Tumors (CPCT-03)

A study testing Everolimus in people with Unspecified Adult Solid Tumor, Protocol Specific, run by UMC Utrecht at 3 sites in Netherlands.

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 investigators hypothesize that certain mutations in the individual cancer genomes will predict response to Everolimus therapy. To identify possible genetic mutations that affect tumor response to Everolimus the investigators will obtain sequence analysis of tumors from all patients that will be treated with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
3 sitesNetherlands
Study dates
Aug 2012to Nov 2016
Phase
Interventional
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

  • Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up
  • Age ≥ 18 years
  • Diagnosis of malignant tumor showing progressive disease according to investigators opinion
  • WHO performance status of (0-2)
  • Measurable disease allowing for volumetric measurements
  • No availability of standard of care systemic treatment options or patient refuses to receive standard of care chemotherapy treatment
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  • A female is eligible to enter and participate in this study if she is of: Non-childbearing potential
  • Adequate organ system function as defined in the protocol
  • Fasting serum cholesterol ≤ 300 mg/dl or 7.75 mmol/L and fasting triglycerides ≤ 2.5 × ULN.

Who cannot join

  • Previous treatment with mTOR inhibitors/pi3k inhibitors/AKT inhibitors
  • Uncontrolled hypertension defined as RR > 160/95 mmHg
  • Serious non-healing wound, ulcer or bone fracture
  • Within 7 days of surgery (including minor procedures)
  • Known and/or symptomatic intracerebral metastases
  • Pregnancy or breast feeding, reproductive potential not using effective birth control methods
Show all 26Show fewer
  • Severe medical condition(s) prohibiting participation in the study
  • Use of other investigational agents now or last 28 days prior to study treatment start
  • Unable or unwilling to discontinue use of interacting medications or modify the dosing of interacting drugs for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
  • Less than four weeks after regular treatment/ palliative radiotherapy
  • Prolongation of Fridericia corrected QT interval (QTcF) > 480 milliseconds
  • Any severe and / or uncontrolled medical conditions such as:
  • Unstable angina pectoris, symptomatic congestive heart failure myocardial infarction ≤6 months prior to enrollment, serious uncontrolled cardiac arrhythmia
  • Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN
  • Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs
  • Significant symptomatic deterioration of lung function.
  • Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin and acetylsalicylic acid or equivalent, as long as the INR is < 2.0)
  • Patients with a known history of HIV seropositivity
  • Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A within the last 5 days prior to enrollment
  • Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry except in cases outlined below:
  • Topical applications (e.g. rash)
  • Inhaled sprays (e.g. obstructive airways diseases),
  • Eye drops
  • Local injections (e.g. intra-articular) are allowed.
  • Patients on stable low dose of corticosteroids for at least two weeks before enrollment are allowed in case of treatment of brain metastases .

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • NKI-AVL

    Amsterdam, North Holland, 1066 CX

  • Erasmus Medical Center

    Rotterdam, South Holland, 3075 EA

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: A Two Parts, Biomarker Study to Identify Genetic Aberrations Predictive for Response on Everolimus in Solid Tumors Without Regular Treatment Options (CPCT-03)

The investigators hypothesize that certain mutations in the individual cancer genomes will predict response to Everolimus therapy. To identify possible genetic mutations that affect tumor response to Everolimus the investigators will obtain sequence analysis of tumors from all patients that will be treated with Everolimus in this study. Moreover, the investigators performed a systematic review of the currently available data to identify mutations that could be predictive for increased mTOR activity in cancer cells. These mutations have been described to lead to mTOR activation but their predictive value for response to Everolimus therapy remains unclear. The investigators will use the data generated in the investigators own prospective treatment study and the data from literature to select patients for entry into a second part of this trial. In this part the investigators want to test the hypothesis that selecting patients based on their specific genetic mutations increases the likelihood of response.

Being tested
Everolimus
Keywords
solid tumors, all comers, everolimus, biomarker, next generation sequencing

What participants receive

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

  • EverolimusDrug

    Also called Affinitor

    All patients will receive everolimus 10mg q.d.

Study groups in NCT01566279
Study groupRoleWhat they receive
everolimusOtherAll patients in first part will receive everolimus 10mg q.d.
Receives: Drug: Everolimus

What is being measured

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

  1. analyse a set of 1951 genes for prediction of response measured by time to progression (TTP) ratio (defined as the TTP without drug: TTP on drug) on mTOR inhibition.

    Inclusion until earliest date of disease progression (defined as a 30% volumetric increase in tumorvolume or appearance of new lesions)

    Measured: An expected average of 5 months

Secondary outcomes (4)

  1. Progression free survival

    Time from initiation of everolimus to, either radiological (RECIST 1.1) or clinical disease progression or death from any cause.

    Measured: An expected average of 4 months

  2. Disease control rate (DCR)

    Disease control rate (DCR) (DC = CR or PR or SD) as defined by RECIST 1.1 3 months after initiation of Everolimus.

    Measured: At 3 months after initiation of everolimus

  3. Toxicity

    Toxicity will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version v4.03: June 14, 2010

    Measured: An expected average of 6 months

  4. Median overall survival

    The (median) time from initiation of Everolimus to time of death or censored at the date of last follow-up. First analysis of overall survival will be performed within one year after inclusion of last subject.

    Measured: An expected average of one year

Timeline

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

  1. First posted29 Mar 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionNov 2015
  4. Study completionNov 2016

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 N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01566279
Sponsor's protocol ID
NL 37128.031.11
Other IDs
2011-002562-20
Acronym
CPCT-03
Status last verified
Mar 2018
First submitted
27 Mar 2012
Last updated
9 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • Cirkel GA, Weeber F, Bins S, Gadellaa-van Hooijdonk CG, van Werkhoven E, Willems SM, van Stralen M, Veldhuis WB, Ubink I, Steeghs N, de Jonge MJ, Langenberg MH, Schellens JH, Sleijfer S, Lolkema MP, Voest EE. The time to progression ratio: a new individualized volumetric parameter for the early detection of clinical benefit of targeted therapies. Ann Oncol. 2016 Aug;27(8):1638-43. doi: 10.1093/annonc/mdw223. Epub 2016 May 27.

    PubMed 27234642

Questions about this trial

What is this clinical trial studying?

A study testing Everolimus in people with Unspecified Adult Solid Tumor, Protocol Specific, run by UMC Utrecht at 3 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 9 inclusion and 26 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

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?

analyse a set of 1951 genes for prediction of response measured by time to progression (TTP) ratio (defined as the TTP without drug: TTP on drug) on mTOR inhibition. (time frame: An expected average of 5 months). 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 NCT01566279, which also lists 1 linked publication.

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 Mar 2018.

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