Metastatic Renal Cell Carcinoma MedDRA version: 9.1 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma
Conditions
Interventions
Product Code: AV-951
Pharmaceutical Form: Capsule, hard
CAS Number: 682745-41-1
Current Sponsor code: AV-951
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-
Pr
Sponsors
AISAR ASSOCIAZIONE ITALIANA PER LO STUDIO DEGLI ANTIMICROBICI E DELLE RESISTENZE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.≥ 18-year-old males or females 2.Histologically confirmed renal cell carcinoma. 3.Documented metastatic disease 4.Clinical and laboratory data that at discretion of the investigator allow to perform contrast enhancement CT scan 5.Measurable disease by RECIST criteria (see Appendix A) 6.No more than 1 prior VEGF receptor targeted therapy; no prior treatment with everolimus (RAD-001; Certican) or other drugs targeting the mTOR pathway 7.ECOG performance =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Primary CNS malignancies; active CNS metastases 2.Hematologic malignancies (including leukemia in any form, lymphoma, and multiple myeloma) 3.Any of the following hematologic abnormalities:Hemoglobin 1.5 × ULN,AST or ALT > 2.5 × ULN (or > 5 x ULN for subjects with liver metastasis),GGT > 2.5 x ULN (or > 5 x ULN for subjects with liver metastasis),Alkaline Phosphatase > 2.5 x ULN (or > 5 x ULN for subjects with liver or bone metastasis),Serum albumin 1.5 × ULN,Proteinuria > 2.5 g/24 hours or 3+ with urine dipstick,Any other &#8805; Grade 3 laboratory abnormality at baseline (other than those listed above) 5.Significant cardiovascular disease, including:Active clinically symptomatic left ventricular failure,Active hypertension (diastolic blood pressure > 100 mmHg).Subjects with a history of hypertension must have been on stable doses of anti-hypertensive drugs for &#8805; 4 weeks,Uncontrolled hypertension:Blood pressure >140/90 mmHg on 2 or more antihypertensive medications,Myocardial infarction within 3 months prior to administration of first dose of study drug 6.Subjects with delayed healing of wounds, ulcers, and/or bone fractures 7.Known pulmonary hypertension or pneumonitis 8.Serious/active infection or infection requiring parenteral antibiotics 9.Inadequate recovery from any prior surgical procedure or major surgical procedure within 6 weeks prior to administration of first dose of study drug 10.Inability to comply with protocol requirements 11.Ongoing hemoptysis or history of clinically significant bleeding 12.Cerebrovascular accident within 12 months prior to administration of first dose of study drug , peripheral vascular disease with claudication on walking less than 1 block, life-threatening lingual angioedema or history of clinically significant angioedema 13.Deep venous thrombosis or pulmonary embolus within 6 months prior to administration of first dose of study drug and/or ongoing need for full-dose oral or parenteral anticoagulation 14.Subjects with a ?currently active? second primary malignancy other than non-melanoma skin cancers. Subjects are not considered to have a ?currently active? malignancy if they have completed anti-cancer therapy and are considered by their physician to be < 30% risk of relapse. 15.Pregnant or lactating women (a pregnancy test is required at screening); all male and female fertile subjects must use adequate contraception (barrier method) while on study and for 3 months thereafter. (Note: Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are not considered effective for this study.) 16.Known concomitant genetic or acquired immune suppression disease such as HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To determine the safety, tolerability, and maximum tolerated dose of AV-951 when administered in combination with everolimus;Main Objective: To determine the safety, tolerability, and maximum tolerated dose of AV-951 when administered in combination with everolimus;Secondary Objective: To characterize the serum concentration of AV-951 and everolimus when administered alone (AV-951) and in combination. To evaluate the antineoplastic activity of AV-951 and everolimus when administered in combination | — |
Countries
Italy
Outcome results
None listed