Clinical trial · Interventional
Study of Cabozantinib (XL184) in Adults With Advanced Malignancies
A Randomized Discontinuation Study of XL184 in Subjects With Advanced Solid Tumors
NCT00940225CI-TRIAL-00076465completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 2 study to evaluate the efficacy and safety of cabozantinib (XL184) in subjects with selected advanced tumor types.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabozantinib | Drug | Cabozantinib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Lead-in Stage - cabozantinib (XL184)
- description
- Open Label, cabozantinib, 100 mg, po QD for 12 weeks.
- interventionNames
- Drug: Cabozantinib
- type
- EXPERIMENTAL
- label
- Randomized Stage - cabozantinib (XL184)
- description
- Blinded, cabozantinib, 100 mg, po QD until disease progression.
- interventionNames
- Drug: Cabozantinib
- type
- PLACEBO_COMPARATOR
- label
- Randomized Stage - placebo
- description
- Blinded, placebo, 100 mg, po QD until disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject has a cytologically or histologically and radiologically confirmed, advanced, recurrent, or metastatic solid tumor of the nine types listed below: * Pancreatic Cancer * Castration-Resistant Prostate Cancer (CRPC) * Hepatocellular Carcinoma (HCC) * Gastric or Gastroesophageal Junction Cancer * Melanoma * Small Cell Lung Cancer (SCLC) * Ovarian cancer, primary peritoneal or fallopian tube carcinoma * Breast cancer that is one of the following subtypes: estrogen receptor positive breast cancer, estrogen receptor/progesterone receptor/HER2-negative (triple-negative), or inflammatory (regardless of receptor status) disease histology * Non-Small Cell Lung Cancer (NSCLC) * Certain requirements for prior therapies may apply * The subject has documented progressive disease at screening * Subjects having any tumor type of other than CRPC must have at least one lesion that is not within a previously irradiated field and is measurable on CT or MRI scan * The subject has recovered to baseline or CTCAE ≤ Grade 1 from toxicities related to prior treatment (some exceptions apply) * The subject is ≥ 18 years old on the day of consent * Tissue samples from archival or fresh tissue, or a tissue block of the subject's tumor * The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * The subject has adequate organ function * The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document * Sexually active fertile subjects (male and female), and their partners, must agree to use medically accepted methods of contraception during the course of the study and for 3 months after the last dose of the study drug(s) * Female subjects of childbearing potential must have a negative pregnancy test at screening Exclusion Criteria: * The subject has experienced clinically-significant hematemesis or hemoptysis of \>0.5 teaspoon of red blood, or other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment * The subject has a cavitating pulmonary lesion(s) or a pulmonary lesion abutting or encasing a major blood vessel * Certain restrictions on prior treatments apply * The subject has known symptomatic or uncontrolled brain metastases or epidural disease * The subject has prothrombin time/International Normalized Ratio (PT/INR) or partial thromboplastin time (PTT) test results that are above (1.3x)the laboratory upper limit of normal * The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or Coumadin-related agents, heparin, thrombin or FXa inhibitors, and antiplatelet agents (low-dose aspirin (≤81 mg/day), low-dose warfarin (≤1mg/day, and prophylactic low molecular weight heparin (LMWH) are permitted) * The subject has a corrected QT interval(QTcF)\>500 ms at screening * The subject has uncontrolled, significant intercurrent illness * The subject is unable to swallow capsules * The subject is pregnant or breastfeeding * The subject has a previously-identified allergy or hypersensitivity to components of the study treatment formulation * The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee * The subject has had another diagnosis of malignancy requiring systemic treatment within the last two years, unless non-melanoma skin cancer, in-situ carcinoma of the cervix, or superficial bladder cancer
References
Publications (9)
- DERIVEDGaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. PMID 37185961
- DERIVEDSchoffski P, Gordon M, Smith DC, Kurzrock R, Daud A, Vogelzang NJ, Lee Y, Scheffold C, Shapiro GI. Phase II randomised discontinuation trial of cabozantinib in patients with advanced solid tumours. Eur J Cancer. 2017 Nov;86:296-304. doi: 10.1016/j.ejca.2017.09.011. Epub 2017 Oct 20. PMID 29059635
- DERIVEDVergote IB, Smith DC, Berger R, Kurzrock R, Vogelzang NJ, Sella A, Wheler J, Lee Y, Foster PG, Weitzman R, Buckanovich RJ. A phase 2 randomised discontinuation trial of cabozantinib in patients with ovarian carcinoma. Eur J Cancer. 2017 Sep;83:229-236. doi: 10.1016/j.ejca.2017.06.018. Epub 2017 Jul 26. PMID 28755607
- DERIVEDKelley RK, Verslype C, Cohn AL, Yang TS, Su WC, Burris H, Braiteh F, Vogelzang N, Spira A, Foster P, Lee Y, Van Cutsem E. Cabozantinib in hepatocellular carcinoma: results of a phase 2 placebo-controlled randomized discontinuation study. Ann Oncol. 2017 Mar 1;28(3):528-534. doi: 10.1093/annonc/mdw651. PMID 28426123
- DERIVEDTolaney SM, Nechushtan H, Ron IG, Schoffski P, Awada A, Yasenchak CA, Laird AD, O'Keeffe B, Shapiro GI, Winer EP. Cabozantinib for metastatic breast carcinoma: results of a phase II placebo-controlled randomized discontinuation study. Breast Cancer Res Treat. 2016 Nov;160(2):305-312. doi: 10.1007/s10549-016-4001-y. Epub 2016 Oct 6. PMID 27714541
- DERIVEDLeibowitz-Amit R, Pintilie M, Khoja L, Azad AA, Berger R, Laird AD, Aftab DT, Chi KN, Joshua AM. Changes in plasma biomarkers following treatment with cabozantinib in metastatic castration-resistant prostate cancer: a post hoc analysis of an extension cohort of a phase II trial. J Transl Med. 2016 Jan 13;14:12. doi: 10.1186/s12967-015-0747-y.