Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study of Apixaban for the Prevention of Thromboembolic Events in Patients Undergoing Treatment for Advanced Cancer: A Phase 2 Pilot Study
Brief Summary: The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.


Options:
A: Inclusion Criteria:

* A histologic diagnosis of malignancy;
* At planned initiation of a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen);
* A risk score for VTE ≥3 \[assign score of 2 for very high risk sites of cancer (stomach, pancreas), score of 1 for high risk site (lung, lymphoma, gynecologic, bladder, testicular) and score of 0 for all other sites\], hemoglobin \<10 g/dL or planned use of erythropoiesis stimulating agents, platelet count ≥350,000/mm3, total leukocyte count \> 11,000/mm3 or body mass index ≥ 35 kg/m2\]. Any counts meeting criteria drawn within 2 weeks prior to enrollment are considered acceptable.
* Age 18 years or older
* Provide written, informed consent.

Exclusion Criteria:

* Active bleeding or at high risk of serious bleeding complication in the opinion of the investigator
* Diagnosis of primary brain tumor multiple myeloma, leukemia, or myelodysplastic syndrome
* Planned stem cell transplant
* Life expectancy \< 6 months
* Known allergy to heparin or LMWH
* Patient or caregiver incapable of daily self-injection
* Acute or chronic renal insufficiency with creatinine clearance \< 30 mL/min
* History of heparin-induced thrombocytopenia
* Allergy to contrast agents
* Pregnancy
* Need for anticoagulant therapy
* Platelet count \< 75,000/mm3
B: Key Inclusion Criteria:

* Recipients of either first- or second-line chemotherapy for advanced or metastatic lung, breast, gastrointestinal, bladder, ovarian, or prostate cancer or myeloma, selected lymphomas, or cancer of unknown origin
* Able to begin study medication ≤6 weeks of starting either first- or second-line chemotherapy.
* Expected course of chemotherapy must have been ≥ 90 days after the start of chemotherapy
* Per Protocol Amendment 5, patients receiving bevacizumab were eligible to participate, provided that bevacizumab was used for indications approved by local country law

Key Exclusion Criteria:

* Women who are pregnant, breastfeeding
* History of deep vein thrombosis or pulmonary embolism
* Active bleeding or at high risk of bleeding
* Metastatic brain cancer
* Familial bleeding diathesis
* Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 4 weeks of study entry
* Expected survival \<6 months or an Eastern Cooperative Oncology Group performance status ≥3.
* Candidates for bone marrow transplantation within the 12-week treatment period or 30-day follow-up period
* Uncontrolled hypertension (systolic blood pressure \>200 mm Hg and/or diastolic blood pressure \>110 mm Hg
* Coagulopathy (international normalized ratio \>1.5 or platelet count \<100\*10\^9/L) if not yet receiving chemotherapy or \<50\*10\^9/L if receiving chemotherapy). Platelet count must have been \>100\*10\^9/L before starting study medication
* One or more of the following: alanine aminotransferase \>3 times the upper limit of normal (ULN), total bilirubin \>2\*ULN, or calculated creatinine clearance \<30 mL/min.
C: Inclusion Criteria:

1. Hospitalized medical patients 70 years of age or older
2. Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
3. written informed consent

Exclusion Criteria:

1. immobilization longer than 3 days prior to randomization
2. prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
3. expected major surgical or invasive procedure within the next 3 weeks after randomization
4. LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
5. immobilization due to cast or fracture
6. indication for anticoagulatory or thrombolytic therapy
7. acute symptomatic DVT / PE
8. known hypersensitivity to any of the study drugs or drugs with similar chemical structures
9. Acute or history of heparin induced thrombocytopenia type II (HIT II)

Other protocol-defined inclusion/exclusion criteria may apply
D: Inclusion Criteria:

Patients must meet all of the following criteria to be considered for enrolment:

* Women with newly diagnosed, histologically proven EOC are potentially eligible. Patients with primary peritoneal or fallopian tube tumours of equivalent histology are also considered for enrolment. If open or true cut biopsy is not available, fine needle aspiration (FNA) showing an adenocarcinoma is considered diagnostic for EOC if all 4 (a to d) of the following conditions are satisfied:

  1. Patient has a pelvic mass, AND
  2. Any evidence of disease larger than 1 cm in the upper abdomen (unless proven stage IV), AND
  3. Normal mammography within 6 weeks of randomization, AND
  4. Serum CA-125/CEA greater than or equal to 25. If the ratio is less than 25, a barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) must be negative for a primary tumour.
* Between the ages of 18 and 75.
* FIGO stage IIB to IV disease.
* A pre-study CA-125 level at least twice the upper limit of normal.
* Eligible for standard adjuvant treatment with taxane- and platinum-based chemotherapy by meeting all of the following laboratory findings within 7 days prior to randomization:

  1. Absolute granulocyte count of at least 1.5 x 10 9/L (1500 per cubic millimetre).
  2. Platelet count of at least 150 x 109/L (100,000 per cubic millimetre).
  3. Serum creatinine no greater than 177 micromol/L (2.0 mg/dL).
  4. Total bilirubin level no greater than 1.5 times the upper limit of normal at the local centre.
  5. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) levels no greater than 3 times the upper limit of normal of the local centre.

Exclusion Criteria:

* Borderline ovarian tumours.
* Received prior chemotherapy or radiation therapy for EOC.
* Received mouse antibodies anytime during the 28 days prior to the pre-study CA-125 level.
* History of another malignancy, unless disease-free for 5 years or greater; non-melanomatous skin carcinoma or curatively treated carcinoma-in-situ of the cervix are excepted.
* Eastern Cooperative Oncology Group (ECOG) performance score of 3 or 4.
* Life expectancy less than 12 weeks.
* Complete bowel obstruction at the time of study enrolment.
* Receiving long-term anticoagulant therapy for an established indication (e.g., atrial fibrillation, mechanical heart valves).
* Bleeding diathesis (e.g., evidence of DIC, hereditary or acquired bleeding disorder).
* History of allergy to any heparin (e.g., heparin-induced thrombocytopenia).
* Significant cardiac history including myocardial infarction within preceding 6 months, congestive heart failure, clinically relevant atrial or ventricular arrhythmias, history of 2nd or 3rd degree heart blocks unless pacemaker is implanted.
* Serious medical conditions that preclude the administration of chemotherapy, anticoagulant therapy, or adherence to protocol, including but not exclusive to:

  1. Allergic reactions to drugs containing cremophor or compounds chemically related to taxanes or platinum analogues.
  2. Significant neurologic or psychiatric disorder that would impair obtaining informed consent and reliable follow-up.
  3. Uncontrolled hypertension despite optimal medical therapy.
  4. Active, uncontrolled infection.
* Women who are pregnant or lactating or are of childbearing potential but are not using effective contraception.
* Total body weight of less than 40 kg.
* Concurrent treatment with experimental or investigational drugs.
* Unable or unwilling to attend scheduled follow-ups.
* Unable (e.g., language barrier, mental illness) to provide informed consent.

Answer: B