[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

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Adult Solid Tumor,Breast Cancer,Ovarian Cancer,Pancreatic Cancer,Papillary Thyroid Cancer,Primary Brain Tumors,Renal Cell Carcinoma,Salivary Gland Cancers,Sarcomas,Solid Tumors,Cholangiocarcinoma,Colorectal Cancer,Gastrointestinal Cancers,Head and Neck Neoplasms,Lymphoma, Large-Cell, Anaplastic,Melanoma,Neuroendocrine Tumors,Non-Small Cell Lung Cancer

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Investigational product



Phase 2


Hoffmann-La Roche

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Understanding clinical trials

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About the study

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Histologically
  2. or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
  3. Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a gene rearrangement of interest may be eligible provided they meet all other inclusion/
Exclusion criteria
  1. Current participation in another therapeutic clinical trial
  2. Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements
  3. Note: prior treatment with crizotinib is permitted only in ALK
  4. or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
  5. History of other previous cancer that would interfere with the determination of safety or efficacy
  6. Incomplete recovery from any surgery
  7. History of non-pharmacologically induced prolonged QTc interval
  8. History of additional risk factors for torsade de pointes
  9. Peripheral neuropathy Grade ≥ 2
  10. Known active infections
  11. Active gastrointestinal disease or other malabsorption syndromes
  12. Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
  13. Other protocol specified criteria

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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