Phase 1 Completed N=21 Treatment

A Study of IMC-A12 in Advanced Solid Tumors

Source: ClinicalTrials.gov NCT01007032 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Feb 2019

Primary outcomePrimary: Summary Listing of Percentage of Participants Reporting Treatment-Emergent Adverse Events — 100; 85.7; 100; 85.7 percentage of participants

Summary

In this study, participants will initially receive intravenous (IV) cixutumumab (IMC-A12) every 2 weeks or every 3 weeks for 6 weeks (one cycle). After the first cycle, participants experiencing a best overall response of complete response, partial response, or stable disease will continue to receive cixutumumab at their cohort dose and schedule until there is evidence of progressive disease (PD), or until other withdrawal criteria are met. Participants will be enrolled at one study center, located in the National Cancer Center Hospital - East, Kashiwa, Japan. Approximately 20-30 participants are anticipated.

Outcome Measures

Outcome	Result	p-value
PRIMARY Summary Listing of Percentage of Participants Reporting Treatment-Emergent Adverse Events	100; 85.7; 100; 85.7	—
PRIMARY Number of Participants With a Dose Limiting Toxicity (DLT)	0; 0; 0; 0	—
PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax)	184; 643; 1020; 1390; NA; 734	—
PRIMARY PK: Area Under the Curve From Zero to Infinity AUC(0-∞)	26500; 42000; 120000; 157000	—
PRIMARY PK: Area Under Concentration Versus Time Curve During One Dosing Interval (AUCtau)	36400; 63600	—
PRIMARY Half-life (t1/2)	6.08; 4.06; 9.88; 8.83; NA; NA	—
PRIMARY Drug Clearance (CL)	0.0137; 0.0135; NA; 0.00709; NA; 0.00994	—
SECONDARY Number of Participants With Serum Anti-Cixutumumab Antibody Assessment Immunogenicity	—	—
SECONDARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])	0.0; 0.0; 0.0; 0.0	—

Eligibility Criteria

Inclusion Criteria

Solid tumor participant who has been histopathologically or cytologically documented
Advanced primary or recurrent solid tumor participant who has not responded to standard therapy or for whom no standard therapy is available
The participant has measurable or nonmeasurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) guidelines
The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS)score of 0-1 at study entry
The participant is able to provide informed consent
The participant is age 20 years or older
The participant has a life expectancy of > 3 months
The participant has adequate hematologic function, as defined by:
An absolute neutrophil count (ANC) ≥ 1500/m3 or /μL
A hemoglobin ≥ 10 g/dL; and
A platelet count ≥ 100, 000/mm3 or /μL
The participant has adequate hepatic function, as defined by:
Total bilirubin ≤ 1.8 mg/dL
Aspartate transaminase (AST) ≤ 2.5 times the upper limit of site-specific normal ranges (five times in case of liver metastasis)
Alanine transaminase (ALT) ≤ 2.5 times the upper limit of site-specific normal ranges (five times in case of liver metastasis)
The participant has adequate renal function, as defined by:
Serum creatinine ≤ 1.5 mg/dL
Calculated serum creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min
The participant has fasting blood sugar 150 mm Hg, diastolic blood pressure > 95 mm Hg)
Cardiac arrhythmia requiring treatment (NCICTCAE Version 3.0 Grade 3), or asymptomatic sustained ventricular tachycardia
Peripheral neuropathy of any etiology ≥ Grade 2 (NCI-CTCAE Version 3.0); or
Any other serious uncontrolled medical disorder(s) in the opinion of the investigator
The participant has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to study entry
The participant has experienced any Grade 3/4 gastrointestinal bleeding within 3 months prior to study entry
The participant has participated in clinical studies of unapproved experimental agents or procedures within 4 weeks prior to study entry for small molecules, or 8 weeks prior to study entry for unapproved monoclonal antibodies
The participant has received any previous treatment with agents targeting the insulin-like growth factor hormone (IGF-IR), approved or unapproved
The participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded
The participant, if female, is pregnant (confirmed by urine or serum pregnancy test) or lactating
The participant has a known alcohol or drug dependency
The participant is Hepatitis B Virus (HBV) antigen-, Hepatitis C Virus (HCV) antibody-, or HIV antibody-positive (asymptomatic healthy carriers with detectable HBV-DNA, HCV-RNA may be enrolled into the trial)
The participant is assessed as inadequate for the study by the investigator

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Data sourced from ClinicalTrials.gov (NCT01007032). 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.