Study testing at how mTOR inhibiting drugs work in kidney cancer.

Phase 1

• Conditions: Renal cancer; MedDRA version: 14.1 Level: PT Classification code 10038389 Term: Renal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022589-29-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1.Localised or metastatic renal cell cancer, any histological subtype, suitable for repeat sampling. Prior histological proof is not required, but scan appearances of newly diagnosed patients should be consistent with localised or metastatic RCC.
2.Age >=18 years.
3.ECOG performance status 0-2
4.Life expectancy >3 months
5.Either: scheduled for biopsy and nephrectomy, or metastatic disease, suitable for 2 CT-guided biopsies, including accessible deposits >2cm in soft tissue or bone.
6.Untreated or previously treated with systemic therapy including multi-kinase inhibitor (eg sunitinib, sorafenib), immunotherapy (eg interferon) or experimental therapy. Radiotherapy is acceptable provided lesion chosen for biopsy is outside the irradiated field.
7. Able to give written informed consent and cooperate with protocol.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Clinical or CT scan features inconsistent with RCC unless pathologically confirmed.
2.Uncontrolled brain metastases.
3.Radiotherapy, major surgery, significant traumatic injury, systemic anti-cancer therapy (including immunotherapy, kinase inhibitor or experimental therapy) during the four weeks prior to starting study treatment.
4.Previous treatment with Rapamycin or Rapalogue (eg Everolimus, Temsirolimus).
5.Current or recent (within 10 days of Rapamycin) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed.
6.History or evidence of inherited bleeding diathesis or coagulopathy with risk of bleeding.
7.Uncontrolled diabetes mellitus (HbA1c >8%).
8.Clinically significant (i.e. active) cardiovascular disease for example CVA (=6 months before enrolment), myocardial infarction (MI) (=6 months before enrolment) unstable angina, CHF NYHA Class =II study, cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted).
9.Non-healing wound, active peptic ulcer or bone fracture.
10.Known hypersensitivity to Rapamycin and any of its excipients.
11.Other psychological, social or medical condition, physical examination finding or laboratory abnormality that the Investigator considers would make the patient a poor study candidate, or could interfere with protocol compliance or the interpretation of results.
12.Co-administration of Rapamycin with strong inhibitors of CYP3A4 (such as ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampin, rifabutin). Low dose corticosteroids are permitted.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified