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

18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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

Inclusion Criteria:

- 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

- Inclusion in the CPCT-02 study

- Age ≥ 18 years

- Diagnosis of malignant tumor showing progressive disease according to investigators

- 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

- 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.

Exclusion Criteria:

- 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

- Severe medical condition(s) prohibiting participation in the study

- Use of other investigational agents now or last 28 days prior to study treatment

- 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:

1. Unstable angina pectoris, symptomatic congestive heart failure myocardial
infarction ≤6 months prior to enrollment, serious uncontrolled cardiac

2. Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN

3. 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

4. Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of study drugs

5. 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:

1. Topical applications (e.g. rash)

2. Inhaled sprays (e.g. obstructive airways diseases),

3. Eye drops

4. Local injections (e.g. intra-articular) are allowed.

5. Patients on stable low dose of corticosteroids for at least two weeks before
enrollment are allowed in case of treatment of brain metastases .

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

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.

Outcome Description:

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

Outcome Time Frame:

An expected average of 5 months

Safety Issue:


Principal Investigator

M.P.J.K. Lolkema, MD/PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht


Netherlands: Medical Ethics Review Committee (METC)

Study ID:

NL 37128.031.11



Start Date:

August 2012

Completion Date:

June 2014

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • solid tumors
  • all comers
  • everolimus
  • biomarker
  • next generation sequencing
  • Neoplasms