Phase 1
Completed N=21
Safety Study of rhuMAb 2C4 to Treat Advanced Solid Tumors
Neoplasms
Source: ClinicalTrials.gov NCT00027027 ↗
Enrolled (actual)
21
Serious AEs
52.4%
Results posted
Jul 2015
Primary outcomePrimary: Number of Participants With an Adverse Event (AE), Serious Adverse Event (SAE), or Death — 3; 3; 4; 3 participants
Summary
The purpose of this Phase I study is to test the safety of rhuMAb 2C4 to see what effects (good and bad) it has on patients with certain types of cancer, and also to find the highest dose of rhuMAb that can be given without causing severe side effects. All study participants will be assigned to specific group to evaluate different dosages of rhuMAb 2C4. The study is scheduled to run for up to one year depending on how patients respond to the study treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Adverse Event (AE), Serious Adverse Event (SAE), or Death |
3; 3; 4; 3; 8; 3 | — |
| PRIMARY Number of Participants With Dose-Limiting Toxicities (DLTs) |
3; 1; 2; 0; 6 | — |
| SECONDARY Pharmacokinetic Measurement of Area Under the Curve (AUC) |
43.057; 569.433; 1478.000; 3959.333; 4502.625 | — |
| SECONDARY Pharmacokinetic Measurement of Systemic Clearance (CL) |
13.1; 3.74; 3.52; 2.69; 3.68 | — |
| SECONDARY Pharmacokinetic Measurement of Volume of Central Compartment (Vc) |
43.6; 35.5; 39.7; 38.4; 42.8 | — |
| SECONDARY Pharmacokinetic Measurement of Steady-State Volume of Distribution (Vss) |
69.5; 74.1; 73.4; 85.3 | — |
| SECONDARY Pharmacokinetic Measurement of Initial Distribution Half-Life (t1/2 Initial) |
0.96; 1.09; 1.23; 1.50 | — |
| SECONDARY Pharmacokinetic Measurement of Terminal Half-Life (t1/2 Terminal) in Days |
2.6; 14.9; 17.2; 22.3; 18.6 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Age >=18 years old
- ECOG performance status of 0 or 1 (see Appendix F)
- Life expectancy of >=12 weeks
- Histologically documented, incurable, locally advanced or metastatic solid malignancies
- Disease progression on or after standard effective therapy or a malignancy for which there is no standard therapy
- At least one bi-dimensionally measurable lesion (>=2 cm [>=1 cm on spiral CT scan])
- HER2-negative status as defined by fluorescence in situ hybridization (FISH) testing (only for subjects with breast cancer)
- Use of an effective means of contraception for women of childbearing potential
- Granulocyte count of >=1500/uL, platelet count of >=100,000/uL, and hemoglobin of >=9 g/dL
- Serum bilirubin less than or equal to the upper limit of normal (ULN) and alkaline phosphatase, AST, and ALT =60 mL/min
- International normalized ratio (INR) of 360 mg/m2 or the equivalent
- History of other malignancies within 5 years of Day 1 except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
- History of significant cardiac disease, unstable angina, congestive heart failure, myocardial infarction, or ventricular arrhythmia requiring medication
- Ejection fraction of 11.5 mg/dL)
- Clinically important history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- Known human immunodeficiency virus (HIV) infection
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications
- Major surgery or significant traumatic injury within 3 weeks of Day 1
- Pregnancy or lactation
- Inability to comply with study and follow-up procedures
Data sourced from ClinicalTrials.gov (NCT00027027). 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.