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Phase 2 Completed N=34 Other

A Study in Advanced Solid Tumors

Solid Tumors
Source: ClinicalTrials.gov NCT01063075 ↗
Enrolled (actual)
34
Serious AEs
50.0%
Results posted
Jun 2016
Primary outcomePrimary: Total Carboplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) — 129 micrograms*hour/milliliters (μg•h/mL)

Summary

The primary purpose of this study is to help answer the following research question(s): * To see how the body absorbs, processes, and gets rid of cetuximab when the drug is taken in combination with carboplatin [pharmacokinetic (PK) analysis] * To see if any drug interactions occur between cetuximab and carboplatin.

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Carboplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])		 129 —
PRIMARY
Cetuximab PK: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)		 17200; 16700 —
PRIMARY
Total Carboplatin PK: Maximum Observed Plasma Concentration (Cmax)		 11.5 —
PRIMARY
Cetuximab PK: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)		 199; 199 —
PRIMARY
Total Carboplatin PK: Time of Maximum Observed Plasma Concentration (Tmax)		 1.12 —
PRIMARY
Cetuximab PK: Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss)		 1.15; 3.17 —
PRIMARY
Cetuximab PK: Confirmatory Serum Concentration		 195 —

Eligibility Criteria

Inclusion Criteria

  • The participant has histologically or cytologically confirmed advanced solid tumor that is resistant to standard therapy or for which there is no standard therapy.
  • The participant has measurable or non-measurable disease according to RECIST 1.0 guidelines.
  • The participant has a life expectancy of greater than 3 months.
  • The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • The participant has adequate hematologic function as defined by absolute neutrophil count greater than or equal to 1500/microliter (μL), hemoglobin greater than or equal to 9 grams/deciliter (g/dL), and platelet count greater than or equal to 100,000/μL.
  • The participant has adequate hepatic function as defined by a total bilirubin less than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less than or equal to 5 x the ULN in the presence of known liver metastases).
  • The participant has adequate renal function as defined by serum creatinine less than or equal to 1.5 x the institutional ULN or creatinine clearance greater than or equal to 60 mL/min for participants with creatinine levels above the ULN.
  • The participant has the ability to understand, and the willingness to sign, a written informed consent document.
  • If the participant has received prior therapy with platinum, the time to the first treatment of study drug from the last platinum exposure is >28 days.

Exclusion Criteria

  • The participant has symptomatic brain or leptomeningeal metastasis.
  • The participant has not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0.
  • The participant is receiving any other investigational agent(s).
  • The participant is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy,radiation therapy ( RT), chemoembolization, or targeted therapy. Participants receiving palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible.
  • The participant is receiving therapy with immunosuppressive agents.
  • The participant has known drug or alcohol abuse.
  • The participant has uncontrolled hypertension defined as systolic blood pressure greater than or equal to 180 millimeters of mercury (mm Hg) or diastolic blood pressure greater than or equal to 130 mm Hg.
  • The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or carboplatin.
  • The participant has a medical or psychological condition that would not permit the participant to complete the study or sign informed consent.
  • The participant has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
  • The participant, if female, is pregnant (confirmed by serum or urine beta-human chorionic gonadotropin [β-HCG] pregnancy test) or breastfeeding
  • The participant has had a known positive test result for the human immunodeficiency virus.
  • The participant has an active infection (requiring I.V antibiotics), including tuberculosis.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01063075). 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.

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