Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those W… (NCT01639508) | Clinical Trial Compass
RecruitingPhase 2
Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity
United States86 participantsStarted 2012-07
Plain-language summary
The purpose of this phase II study is to find out what effects cabozantinib (XL184) has, good and/or bad, in patients whose tumors one of the following gene changes RET, ROS1, or NTRK fusion, or increased MET or AXL activity.
A phase II study looks at how effective a medication is at treating a specific type of cancer and collects information on the side effects of the study treatment.
RET, ROS1, or NTRK fusion or increased MET or AXL activity gene leads to lung cancer cell growth. Cabozantinib is an oral medicine that inhibits of RET, ROS1, NTRK, MET, and AXL. In addition, this drug interferes with other cell pathways that also cause cancer cells to grow, form new blood vessels, and spread to other organs of the body. The goal of using cabozantinib is to shrink the cancer and to prevent it from growing
Cabozantinib has been studied and shown to cause cancer shrinkage in other cancers such as medullary thyroid cancer and prostate cancer. We thus have a good idea of what side-effects it causes and can anticipate them.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The subject has a pathologic diagnosis of non-small cell lung carcinoma that is metastatic or unresectable.
✓. Documented presence:
✓. Group A: KIF5B/RET or related variant RET fusions.
✓. Group B: any of the following aberrations
✓. Group C: ROS1 fusion
✓. GROUP D: RET-fusion post-progression on selective RET inhibitor
✓. The subject is ≥ 18 years old on the day of consent.
✓. Measurable Disease by RECIST1.1
Exclusion criteria
✕. Any type of systemic anticancer agent (including investigational) within 3 weeks of first dose of study treatment, or within 5 half-lives of the agent whichever is shorter. Subjects on LHRH or GnRH agonists may be maintained on these agents.
✕. Radiation therapy for bone or brain metastasis within 2 weeks, any other external radiation therapy within 4 weeks of first dose of study drug. Systemic treatment with radionuclides within 4weeks. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
✕. The subject has not recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs.
✕. Known uncontrolled symptomatic brain metastases or cranial epidural disease; subjects previously treated and on stable dose of corticosteroids and/or anticonvulsants for \>10 days, or not requiring such medications, are eligible. Baseline brain scans are not required to confirm eligibility.
✕. The subject requires concomitant treatment, in therapeutic doses, unless deemed clinically unsafe to discontinue, with anticoagulants such as warfarin or warfarin-related agents, unfractionated heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (eg, clopidogrel). Low dose aspirin (≤ 100 mg/day), low-dose warfarin (≤ 1 mg/day) are permitted. Both prophylactic and/or treatment dose low molecular weight (fractionated) heparin (LMWH) are permitted and are the preferred agents to administer.
✕. The subject has experienced any of the following within 3 months before the first dose of study treatment:
✕. The subject has radiographic evidence of cavitating pulmonary lesion(s)