A Multicenter, Open-Label Safety and Pharmacokinetics Study of Chimeric Anti-Phosphatidylserine Monoclonal Antibody in Patients with Refractory Advanced Solid Tumor Malignancies

Summary of the Eligibility Criteria:

Key Inclusion Criteria:

1. Evaluable, histologically or cytologically confirmed, refractory advanced solid tumor malignancy for which standard curative measures do not exist or are no longer effective
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
3. Adequate Laboratory parameters: ANC > 1,500 ; Hgb > 9; Plts > 100,000 and 500,000; Creatinine < 1.5; Total Bilirubin < 1,5 X ULN; AST/ALT < 3 X ULN
4. Normal coagulation profile (PT/INR and aPTT within institutional normal limits)

Key Exclusion Criteria:

1. Prior exposure to any chimeric antibody (Prior exposure to humanized antibodies e.g. Avastin, Herceptin allowed)
2. Any evidence of clinically significant bleeding
3. Known history of bleeding diathesis or coagulopathy
4. Any history of thromboembolic events within the past 12 months
5. Any history of hypercoagulable state (e.g. shortened aPTT)
6. Concurrent therapy with oral or parenteral anticoagulants with the exception of low dose anticoagulants to maintain the patency of indwelling catheters or ports
7. Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen
8. Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
9. Requirement of chronic daily treatment with NSAIDS, anti-platelet drugs, or steroids

A Phase II, Single Arm, Single Agent, Multicentre, Adaptive 2-Stage Study to Evaluate the Efficacy, Safety and Pharmacokinetics of AZD4877Administered Weekly in Patients with Recurrent Advanced UrothelialCancer

Summary of the Eligibility Criteria:

Key Inclusion Criteria:

1. Histologically confirmed (stage IV) transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra). Mixed histology is allowed as long as the predominant histology is TCC
2. Performance Status (ECOG) 0-2
3. First recurrence after treatment with a maximum of two chemotherapeutic regimens, one of which must have been for unresectable and/or locally advanced disease, and the other of which must have been in either the adjuvant or neoadjuvant setting.

Key Exclusion Criteria:

1. Prior treatment with investigational or standard anti-cancer agents, including radiotherapy, within 4 weeks prior to first dose of study treatment; 6 weeks if priorsystemic mitomycin, nitrosourea, or suramin. One exception to this is palliativeradiotherapy given (up to one week prior to study entry) for pain to non-targetlesion bony metastases. Another exception to this is hormonal therapy for prostate cancer.
2. Inadequate bone marrow reserve as demonstrated by absolute neutrophil count (ANC) <1.5 x 109/L, platelet count (PLT) <100 x 109/L, or haemoglobin (Hgb) ?9 g/L
3. Inadequate liver (ALT) or function as demonstrated by alanine amino transferase aspartate transaminase (AST) >2.5 x upper limit of normal (ULN); >5 x ULN in thepresence of liver metastases
4. Impaired renal function, defined by creatinine >1.5 x ULN or creatinine clearance<40 mL/min, estimated by Cockcroft-Gault equation or measured via 24 h urine creatinine
5. Presence of currently active CNS involvement or clinical evidence of active CNS disease
6. Patients with massive pleural effusion or ascites unless drained
7. Pregnant or breast-feeding female

A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram.

Summary of Eligibility Criteria

Key Inclusion Criteria:

1. Patients with locally advanced or metastatic solid tumors who have relapsed or have progressive disease following standard of care treatment with chemotherapy prior to enrollment, or intolerant to prior standard of care treatment with chemotherapy
2. A 12-lead ECG consistent with normal cardiac conduction and function and QTc < 500 ms, QRS< 110ms, PR< 200ms, Pulse between 45 and 90
3. Performance Status (ECOG) 0-1
4. Adequate Laboratory parameters: ANC > 1,500 ; Plts > 100,000; Hgb > 9g/dl ; Creatinine < 1.5 mg/dl ; Total Bilirubin < 1,5 X ULN; direct Bilirubin < ULN; AST/ALT < 2.5 X ULN; Creatine phosphokinase (CPK) < ULN

Key Exclusion Criteria:

1. Patients treated with more than three prior chemotherapy regimens (including adjuvant therapy)
2. Patients with total prior anthracycline over 260 mg/m2 with abnormal LVEF
3. Patients with CNS metastasis
4. Patients with heart rythm disturbances, Unusual T and U wave morphology, blood pressure outside of normal range, a history of cardiac failure, myocardial infraction, or cardiomyopathy, or a history of additional risk factors for torsades de pointed (e.g. heart failure, electrolyte abnormalities, family history of Long QT Syndrome)
5. Patients who at screening are on medication that is known to prolong the QT interval
6. Pregnant or breast-feeding female or woman planning to become pregnant during the study

A Phase 1/2 Study to Investigate the Safety, Tolerability and Potential Activity of IPI-504 in Relapsed and/or Refractory Stage IIIb (with Malignant Pleural or Pericardial Effusion), or Stage IV NSCLC Patients

Summary of Eligibility Criteria

Key Inclusion Criteria:

1. Patients must have pathologically confirmed diagnosis of a Stage IIIb (with malignant pleural or pericardial effusion) or Stage IV NSCLC and be relapsing or refractory to prior treatment.
2. Patients must have failed prior therapy with erlotinib, gefitinib or any other EGFR tyrosine kinase inhibitor.
3. Patients must have an archived or fresh tissue biopsy and evaluation for EGFR mutations. Any known prior EGFR mutation status whether commercially or non commercially obtained is acceptable. Any test performed in a non-CLIA certified lab must be approved by the Sponsor.
4. Performance Status (ECOG) 0-2.

Key Exclusion Criteria:

1. Treatment for NSCLC within 2 weeks of the start of treatment for any small molecule therapy; within 4 weeks of the start of treatment for any biologic therapy or conventional chemotherapy.
2. Concurrent radiation therapy is not permitted. (prior radiation therapy is allowable as long as it has not occurred within 2 weeks of initiating treatment).
3. Initiation or discontinuation of concurrent medication that alters CYP3A activity within 2 weeks of initiating treatment. Patients who are on a stable dose of drugs known to alter CYP3A for > 2 weeks are eligible to enroll.
4. Laboratory parameters: ANC < 1,500 ; Plts < 100,000; Hgb < 9.0 Creatinine > 1.5 X ULN ; Total Bilirubin > 1,5 X ULN; Albumin < 3.0; AST/ALT/Alk Phos > 2.5 X ULN or 3.0 X ULN if patient has liver metastases.
5. Prothrombin Time (PT) and partial thromboplastin time (PTT0 > 1.5 x ULN unless the patient is receiving warfarin. If the patient is receiving warfarin, the international normalized ration (INR) must be within therapeutic range.
6. Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
7. Patients with untreated brain metastases. Note: Patients with a history of brain metastases are eligible as long as definitive treatment has been given and patients are clinically stable.
8. Baseline QTc > 450 msec in males; QTc > 470 msec in females, or previous history of QT prolongation while taking other medications.
9. Sinus bradycardia (resting heart rate < 50) secondary to intrinsic conduction system disease. Patients with sinus bradycardia secondary to pharmacologic treatment may enroll if withdrawal of the treatment results in normalization of the resting heart rate to within normal limits.
10. Presence of left bundle branch block.
11. Women who are pregnant or lactating.
12. Active keratisis or keratoconjunctivitis.