araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

Summary: This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.


Eligibility: Inclusion Criteria:
  -  Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
  -  At least one measurable site of disease on CT/MRI scan
  -  PS≤2
  -  Normal organ, electrolyte, and bone marrow function
  Exclusion Criteria:
  -  Previous treatment with nilotinib or any other drug in this class or other targeted therapy
  -  Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry
  -  Impaired cardiac function
  -  Use of coumarin derivatives (i.e. warfarin)
  -  Women who are pregnant or lactating
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
  PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

Detailed description: OBJECTIVES:
  -  To evaluate the safety and efficacy of imatinib mesylate in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.
  OUTLINE: This is a multicenter study.
  Patients receive oral imatinib mesylate daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of gastrointestinal stromal tumor (GIST)
  -  Hepatic metastasis meeting the following criteria:
  -  No more than 3 hepatic metastases
  -  Clinically diagnosed as surgically resectable with no macroscopic residual tumor
  -  Synchronous hepatic metastasis allowed provided primary tumor is also resectable
  -  No metastatic tumor that requires radiofrequency ablation and/or microwave coagulation therapy to control the disease
  -  No extrahepatic metastasis
  -  No history of GIST recurrence
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-1
  -  Leukocyte count ≥ 3,000/μL
  -  Neutrophil count ≥ 1,500/μL
  -  Hemoglobin ≥ 8.0 g/dL
  -  Platelet count ≥ 75,000/μL
  -  Total bilirubin ≤ 2.0 mg/dL
  -  ALT and AST < 120 IU/L
  -  GTP < 210 IU/L
  -  Not pregnant
  -  No poorly controlled diabetes mellitus
  -  No NYHA class III-IV cardiac function
  -  No hepatitis B or hepatitis B carriers
  -  No other malignancy requiring treatment
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior imatinib mesylate
  -  No prior interventional radiology for metastatic disease
  -  No other concurrent treatment, including surgery or radiotherapy, for metastatic lesions

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Treatment of Patients With RAD001 With Progressive Sarcoma

Summary: The purpose of this multicenter, three-arm, exact binomial single-stage, phase II trial is to determine the preliminary efficacy and safety of RAD001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcoma.


Eligibility: Inclusion Criteria:
  Histological evidence of progressive or metastatic bone or soft tissue sarcoma.
  The following tumor types are included:
  -  malignant fibrous histiocytoma
  -  liposarcoma
  -  synovial sarcoma
  -  malignant paraganglioma
  -  fibrosarcoma
  -  leiomyosarcoma
  -  angiosarcoma including haemangiopericytoma
  -  malignant peripheral nerve sheath tumor
  -  STS, not otherwise specified
  -  miscellaneous sarcoma including mixed mesodermal tumors of the uterus
  -  osteosarcoma
  -  Ewing's sarcoma
  -  rhabdomyosarcoma
  -  gastrointestinal stromal tumor (only after failure or intolerance of imatinib or sunitinib in 1st and 2nd line)
  -  alveolar soft part sarcoma (ASPS)
  -  Objective progression of disease may be documented by RECIST criteria. Any of the following would be sufficient according to RECIST:
  -  a 20% increase in the sum of unidimensionally measured target lesions
  -  a new lesion
  -  unequivocal increase in non-measurable disease.
  -  Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent.
  -  ECOG performance status 0 - 2.
  Exclusion Criteria:
  Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy.
  -  The following tumor types will not be included:
  -  gastrointestinal stromal tumor (except for patients after treatment with imatinib or sunitinib in 1st and 2nd line)
  -  chondrosarcoma
  -  malignant mesothelioma
  -  neuroblastoma.
  -  Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
  -  Neurotoxicity > grade 2 CTC.
  -  Radiation of the lung.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

Summary: RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor.
  PURPOSE: This phase II trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

Detailed description: OBJECTIVES:
  -  To evaluate the safety and efficacy of surgery in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.
  OUTLINE: This is a multicenter study.
  Patients undergo surgical resection of hepatic metastasis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of gastrointestinal stromal tumor (GIST)
  -  Hepatic metastasis meeting the following criteria:
  -  Clinically diagnosed as surgically resectable with no macroscopic residual tumor
  -  No more than 3 hepatic metastases
  -  Synchronous hepatic metastasis allowed provided primary tumor is also resectable
  -  Does not require radiofrequency ablation and/or microwave coagulation therapy to control the disease
  -  No extrahepatic metastasis
  -  No history of GIST recurrence
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-1
  -  Leukocyte count ≥ 3,000/μL
  -  Neutrophil count ≥ 1,500/μL
  -  Hemoglobin ≥ 8.0 g/dL
  -  Platelet count ≥ 75,000/μL
  -  Total bilirubin ≤ 2.0 mg/dL
  -  ALT and AST < 120 IU/L
  -  GTP < 210 IU/L
  -  Not pregnant
  -  No poorly controlled diabetes mellitus
  -  No NYHA class III-IV cardiac function
  -  No hepatitis B or hepatitis B carriers
  -  No other malignancy requiring treatment
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior interventional radiology for metastatic disease
  -  No prior or concurrent imatinib mesylate
  -  No other concurrent treatment

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors

Summary: The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Erlotinib is an orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a single agent for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine for first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.


Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of:
  -  Advanced solid tumor that is no longer responding to therapies OR
  -  Advanced or metastatic NSCLC that has previously been treated with erlotinib or gefitinib
  -  ECOG Performance Status 0-1
  -  Adequate organ and bone arrow function as defined by hematological and serum chemistry limits
  -  At least 18 years old
  -  Both men and women must practice adequate contraception
  -  Informed consent
  Exclusion Criteria:
  -  Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with PI3K, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
  -  Erlotinib intolerant
  -  Taking oral corticosteroids chronically or > 1 mg/day warfarin
  -  Not recovered from the toxic effects of prior therapy
  -  History of diabetes mellitus and an HgbA1c > 7%
  -  Uncontrolled intercurrent illness
  -  Pregnant or breastfeeding
  -  Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
  -  HIV positive
  -  Diagnosis of another malignancy may exclude subject from study

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors

Summary: Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding its best clinical use in terms of tumor response, survival, tolerability and safety profile will be prospectively collected.


Eligibility: Inclusion Criteria:
  1. Patients ≥ 18 years of age.
  2. Histologically documented diagnosis of GIST, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach.
  3. Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry.
  4. At least one measurable site of disease (RECIST Criteria), or other response assessment criteria, as appropriate.
  5. Performance status 0,1, 2 or 3 (ECOG).
  6. Adequate end organ function.
  7. Adequate bone marrow function.
  8. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
  Exclusion Criteria:
  1. Previous treatment with any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
  2. Other primary malignancy with < 5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged after consultation with the Steering committee to entail a low risk of relapse.
  3. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
  4. Pregnancy, breast-feeding.
  5. Severe and/or uncontrolled medical disease.
  6. Known brain metastasis.
  7. Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
  8. Known diagnosis of human immunodeficiency virus (HIV) infection.
  9. Previous treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin-C).
  10. Previous radiotherapy to ≥ 25 % of the bone marrow.
  11. Major surgery within 2 weeks prior to study entry.

Relevance to patient case: definitely relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Study of Tumor Samples in Patients Undergoing Treatment for Gastrointestinal Stromal Tumors on Clinical Trial ACOSOG-Z9001

Summary: RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.
  PURPOSE: This research study is looking at tumor samples in patients undergoing treatment for gastrointestinal stromal tumors on clinical trial ACOSOG-Z9001.

Detailed description: OBJECTIVES:
  Primary
  -  To examine polymorphisms in selected genes involved in the detoxifying/metabolizing and DNA repair pathways in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from patients with gastrointestinal tumors (GIST) undergoing treatment on clinical trial ACOSOG-Z9001.
  Secondary
  -  To examine approximately 758 polymorphisms among candidate genes involved in detoxification/metabolism, cell cycle control, and DNA damage/repair in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from GIST patients for hypothesis generation. (exploratory)
  -  To conduct an exploratory analysis of the polymorphism distribution in these patients. (exploratory)
  -  To examine the association between the above polymorphisms and major toxicity (Grade 3/4) of adjuvant imatinib mesylate. (exploratory)
  OUTLINE: Tumor samples are used for polymorphism and mutation analysis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Tumor samples from patients with gastrointestinal stromal tumors enrolled on clinical trial ACOSOG-Z9001

Relevance to patient case: definitely relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

Summary: The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.

Detailed description: This trial began as a multi-center, randomized, Phase III, controlled trial for nilotinib vs (DTIC) dacarbazine to assess the efficacy and safety of nilotinib (400 mg bid) in patients with c-Kit mutated metastatic and/or inoperable melanoma. The study was open to patients with mucosal or acral melanoma.
  Due to substantial difficulties identifying and recruiting eligible patients, the trial design was altered from a randomized, two-arm, Phase III study to a single-arm, Simon two-stage Phase II study with protocol Amendment 2 (27-Jul-2011). While the original protocol required the recruitment of 120 patients, this amendment required the study to recruit only 41 patients (patients randomized to nilotinib prior to Amendment 2 were to be counted in this total, but those randomized to dacarbazine ( DTIC ) DTIC were not). Patients randomized to DTIC were allowed to cross-over to nilotinib, either immediately or at the time of progression.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed mucosal or acral 2. Presence of a c-Kit mutation of exon 9, 11 or 13, or mutations Y822D and mutations D820Y, Y823D of exon 17, as confirmed by the central laboratory 3. Stage III unresectable or stage IV disease 4. The presence of one or more measurable lesions as detected by radiological or photographic methods and assessed according to RECIST 1.0. Lesions must have a size of at least 10mm at longest diameter (using a slice thickness of 5 mm)or double the slice thickness to be considered a target lesion. Target lesions should not be selected in previously irradiated fields unless there is clear evidence of progression 5. WHO performance status 0 - 2
  Exclusion Criteria:
  1. C-Kit mutation of exons 17(except mutations D820Y, Y822D or Y823D) or any other exon not allowed by the inclusion criteria
  2. Patients with c-Kit amplifications only and no mutation
  3. Patients with any history of brain metastases
  4. Patients who have had any prior treatment with TKIs
  5. Patients receiving medications or herbal extracts which interfere with nilotinib metabolism which are not discontinued by the time of the baseline visit
  6. Acute or chronic liver or renal disease considered unrelated to melanoma
  Other protocol-defined inclusion/exclusion criteria may have applied.

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients

Summary: The purpose of this study is to determine if escalating the dose of imatinib to keep the drug blood level at ≥ 1100 ng/ml leads to better outcomes for patients.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  Unresectable and/or metastatic GIST
  -  Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. This must be the first time that the patient has been treated for metastatic and/or unresectable GIST
  -  For patients who received imatinib following surgery at the time of an initial diagnosis of GIST, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic GIST
  -  Good physical functioning (ECOG Performance Status of 0 or 1)
  -  Generally, good function of organ such as liver and kidneys
  Exclusion Criteria:
  -  Disease progression during adjuvant therapy with imatinib (adjuvant treatment is treatment that is given after surgery for GIST)
  -  Known intolerance of imatinib at a dose of 400 mg/day or higher
  -  Prior systemic therapy for advanced GIST with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease
  -  Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered from prior surgery
  -  Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
  -  Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks or who have not recovered from side effects of this therapy

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Sorafenib for Imatinib/Sunitinib-failed GIST

Summary: With discovery of KIT (CD117) mutations and the advent of KIT tyrosine kinase inhibitor imatinib, there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after imatinib and sunitinib. In preclinical models, sorafenib inhibits KIT activity and cell growth of imatinib-resistant tumors. The objective of this multi-center, non-randomized phase II study is to evaluate the safety and activity of sorafenib given as third-line therapy for GIST.

Detailed description: This is a non-randomized, open-label, multi-center, phase II study recruiting patients with advanced GIST who are pretreated with both imatinib and sunitinib. The current study will provide an estimate of the activity and safety of sorafenib in GIST. The primary study endpoint is the disease control rate (DCR), defined as complete or partial response or stable disease of at least 24 weeks of sorafenib therapy. Secondary endpoints include PFS, OS and safety.
  Patients with advanced (unresectable and/or metastatic) GIST who failed after previous therapy involving both imatinib and sunitinib will be eligible. Failure to imatinib and sunitinib is defined as disease progression regardless of intervening response during therapy, or intolerance. There is no limit to the number of prior therapies a patient may have received (e.g., patients may have received therapy with nilotinib, other TKIs, or chemotherapy in addition to imatinib or sunitinib).

Eligibility: Inclusion Criteria:
  -  age over 18 years
  -  advanced GIST
  -  failed (progressed and/or intolerable) after prior treatments for GIST
  -  ECOG performance status of 0~2
  -  resolution of all toxic effects of prior treatments
  -  no prior radiotherapy within 1 month before registration
  -  measurable lesion as defined by RECIST
  -  adequate marrow, hepatic, renal and cardiac functions
  -  provision of a signed written informed consent
  Exclusion Criteria:
  -  severe co-morbid illness and/or active infections
  -  pregnant or lactating women
  -  history of other malignancies
  -  active CNS disease not controllable with radiotherapy or corticosteroids
  -  active and uncontrollable bleeding from gastrointestinal tract
  -  prior history of sorafenib use
  -  gastrointestinal obstruction or malabsorption syndrome

Relevance to patient case: not relevant
Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

Summary: This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic
  -  Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose
  -  At least one measurable site of disease on CT scan at Visit-2
  -  WHO Performance Status of 0, 1 or 2 at Visit-2
  -  Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2
  Exclusion Criteria:
  -  Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib.
  -  Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks
  -  Prior or concomitant malignancies other than GIST
  -  Impaired cardiac function at Visit-1 or 2
  -  Patients with severe and/or uncontrolled concurrent medical disease
  -  Use of therapeutic coumarin derivatives
  -  Use of any medications that prolong the QT interval
  -  Use of CYP3A4 inhibitors
  -  Patients who have undergone major surgery ≤ 2 weeks prior to Visit-1 or who have not recovered from side effects of such surgery
  -  Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks prior to Visit-1 or who have not recovered from side effects of such therapy
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant