Clinical trial · Interventional
A Study of the Safety and Pharmacology of MEGF0444A in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MEGF0444A, a Human IgG1 Antibody, in Combination With Bevacizumab and Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
NCT01075464CI-TRIAL-00024589completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combination with bevacizumab, and in combination with bevacizumab and paclitaxel as therapy for locally advanced or metastatic solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Cancers | Malignant Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| MEGF0444A | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: MEGF0444A
- Drug: bevacizumab
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: MEGF0444A
- Drug: bevacizumab
- Drug: paclitaxel
Primary outcomes (2)
- measure
- Incidence and nature of dose-limiting toxicities (DLTs)
- timeFrame
- Days 1 to 28 of Cycle 1
- measure
- Incidence, nature, and severity of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on or failed to respond to regimens or therapies known to provide clinical benefit Specific to Arm A: * For patients undergoing optional or mandatory exploratory MRI, at least one tumor lesion that represents a liver, fixed peritoneal, neck, extremity, or pelvic lesion measuring \>/= 3 to 10 cm (for liver lesions) or \>= 2 to 10 cm (for all other lesion locations) to be used for MRI Specific to Arm B: * Maximum of two prior chemotherapy regimens for metastatic disease Exclusion Criteria: * Anti-cancer therapy within 3 weeks prior to initiation of study treatment * Patients who had to discontinue prior bevacizumab therapy due to intolerable toxicity * Leptomeningeal disease * Active infection or autoimmune disease * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis * Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases * Inadequately controlled hypertension; history of hypertensive crisis or encephalopathy; congestive heart failure (New York Heart Association Class II or greater); history of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment * History of hemoptysis; evidence of bleeding diathesis or significant coagulopathy * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment * Serious, non-healing wound, active gastrointestinal ulcer, or untreated bone fracture Specific to Arm B: * Known significant hypersensitivity to paclitaxel or other drugs using the vehicle cremophor * Previous intolerance to paclitaxel * Grade \>= 2 sensory neuropathy
References
Publications (0)
Data not yet available
No reference posted for this study.