Phase 1
Completed N=35
Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
Source: ClinicalTrials.gov NCT01588548 ↗Enrolled (actual)
35
Serious AEs
22.9%
Results posted
Aug 2015
Primary outcomePrimary: Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) — 0; 0; 0; 0 Participants
Summary
The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study
- Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist
- Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks.
- Patients who have at least one lesion that can be accurately assessed
Exclusion Criteria
- Patients who have recently received or are receiving prohibited medications or treatments
- Patients who have any unresolved side effects of previous treatments
- Patients who have spinal cord compression or brain metastases
- Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus [HIV] infection)
- Patients with significant abnormal ECG findings
Data sourced from ClinicalTrials.gov (NCT01588548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.