NL-OMON40040
Recruiting
N/A
A two parts, biomarker study to identify genetic aberrations predictive for response on Everolimus in solid tumors without regular treatment options (CPCT*03) - CPCT-03
Antoni van Leeuwenhoek Ziekenhuis0 sites80 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- regular therapy refractory cancer
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 CPCT\-02 study
- •\- 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
- •\- A female is eligible to enter and participate in this study if she is of: Non\*childbearing potential (i.e., physiologically incapable of becoming pregnant) or by using adequate contraception
- •\- Adequate organ system function.
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 methods
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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