Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–100
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For All Cohorts:
Adult ≥ 18 years old.
Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy.
Presence of at least 1 measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Adequate bone marrow and organ function per defined criteria in the protocol.
Recovered from acute laboratory and clinical toxicities of prior anti cancer treatment to NCI CTCAE v5.0 grade ≤1 at time of screening, except alopecia and amenorrhea.
For Cohort A:
First line metastatic colorectal adenocarcinoma.
For Cohort B:
Second line metastatic colorectal adenocarcinoma that has progressed on prior line of chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin.
For Cohort C:
Second line metastatic gastroesophageal adenocarcinoma that has progressed on prior line of chemotherapy administered for metastatic disease, and which must include a platinum agent and fluoropyrimidine doublet.
For Cohort D:
Second or third line metastatic renal cell carcinoma with a clear cell component and has received one or two lines of treatment for metastatic disease that included an anti angiogenic agent for at least 4 weeks with radiologic progression on that treatment.
For subjects starting from Part 1a in Cohorts A and B:
Serum hs CRP at screening ≥ 10 mg/L (per central laboratory assessment).
Not requiring immediate initiation of anti cancer therapy per investigator's best judgement.
For subjects starting from Part 2 in Cohort C:
Serum hs CRP at screening ≥ 10 mg/L (per central laboratory assessment).
You may not be if
For All Cohorts:
Currently receiving any of the prohibited medications or has contraindications as outlined in the 'Contraindications' to SOC regimen components.
Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery).
Suspected or proven immunocompromised state, or infections (as defined in the protocol).
Conditions that have a high risk of clinically significant bleeding after administration of anti VEGF agents.
Clinically significant, uncontrolled or recent (within last 6 months) cardiovascular disease.
For Cohort D:
Concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5, and medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
Impairment of GI function or GI disease that may significantly alter the absorption of cabozantinib.
