Phase 1
Completed N=172
Study of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients With Advanced Solid Tumors or Lymphoma
Source: ClinicalTrials.gov NCT00705874 ↗Enrolled (actual)
172
Serious AEs
44.8%
Results posted
Feb 2012
Primary outcomePrimary: Maximum Tolerated Dose (MTD) — NA; NA; 590; 590 mg
Summary
This study will aims to determine the maximum tolerated dose of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated until the maximum tolerated dose is established.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
NA; NA; 590; 590; 590; 590 | — |
| SECONDARY Drug Safety |
— | — |
| SECONDARY Pharmacokinetics |
— | — |
Eligibility Criteria
Inclusion Criteria
- non-hematological advanced solid tumor malignancy or lymphoma where no curative therapy exists in which monotherapy with gemcitabine or docetaxel or bevacizumab or erlotinib or cisplatin, or 5-flurouracil or sunitinib would otherwise be warranted.
- measurable disease based on radiographic evaluation or elevated tumor markers.
- ECOG - 0 or 1 (KPS >70).
- Life expectancy > 3 months.
Exclusion Criteria
- chemotherapy within 21 days or radiotherapy within 4 weeks prior to entering the study
- known active brain metastases or leptomeningeal carcinomatosis.
- history of a myocardial infarction within the prior 6 months or, hospitalizations for congestive heart failure within the prior 6 months, or active treatment for uncontrolled cardiac arrhythmias
- clinically significant gastrointestinal tract hemorrhage, requiring transfusion therapy, within the prior 3 months.
Data sourced from ClinicalTrials.gov (NCT00705874). 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.