Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cixutumumab · 3 trials · 4 indications
PFS was defined as the time from date of randomization until the date of disease progression, or death from any cause, whichever was first. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation for disease progression or death were censored at the date of last tumor assessment. The PFS was estimated following the Kaplan-Meier method.
Percentage of participants who are alive and progression-free at 6 month from start of the study treatment over all participants. PFS is defined as the time from the start of study treatment until the date of objectively determined progressive disease (PD) or death due to any cause. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS was estimated by the binomial distribution and Kaplan-Meier method.
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
DLTs were defined as any cixutumumab-related Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) Grade 3 or 4 adverse events (reported in the subsequent Primary Outcome Measure).
| Arm | Type | Description |
|---|---|---|
| Pemetrexed + Cisplatin + Cixutumumab | EXPERIMENTAL | Induction Treatment: Pemetrexed 500 mg/m\^2 plus cisplatin 75 mg/m\^2 plus cixutumumab 20 mg/kg given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval. Maintenance Therapy: Pemetrexed 500 mg/m\^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. |
| Pemetrexed + Cisplatin | ACTIVE_COMPARATOR | Induction Treatment: Pemetrexed 500 mg/m\^2 plus cisplatin 75 mg/m\^2 given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval. Maintenance Therapy: Pemetrexed 500 mg/m\^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. |
| Carcinoid tumor | EXPERIMENTAL | Participants with carcinoid tumor will receive cixutumumab 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen. |
| Islet cell carcinoma | EXPERIMENTAL | Participants with islet cell carcinoma will receive cixutumumab 10 mg/kg over 1 hour every 2 weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen. |
| Cixutumumab | EXPERIMENTAL | Participants receive IV cixutumumab every 2 or 3 weeks. A cycle equals 6 weeks, with radiological evaluation of tumor response after each cycle. After 1st cycle, pts with a complete response (CR), PR, or SD continue to receive cixutumumab cohort dose and schedule disease progression. 3 pts enroll in each cohort. Starting dose in Cohort 1 is 6 mg/kg every 2 weeks. Dose escalation from Cohort 1 to Cohort 2 (10 mg/kg every 2 weeks) occurs at least 3 pts in Cohort 1 completes 1 cycle of therapy. Enrollment into Cohort 3 (starting dose: 15 mg/kg administered every 3 weeks) will not proceed until at least 3 pts have completed one cycle of therapy in Cohort 2. Pts enroll in Cohort 4 once at least 3 pts have completed once cycle of therapy in Cohort 3; pts in Cohort 4 receive 20 mg/kg every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| Pemetrexed | DRUG | Administered intravenously (IV) |
| Cisplatin | DRUG | Administered IV |
| Cixutumumab | DRUG | Administered IV |
| depot octreotide | DRUG | Participants must be receiving depot octreotide at the time of enrolling into the study. Participants on stable doses of depot octreotide will continue to receive the same dose and schedule of their last regimen. |
Inclusion Criteria: * The participant has histologically or cytologically confirmed, nonsquamous (adenocarcinoma/large cell or other) NSCLC. * The participant has Stage IV disease at the time of study entry. * Participants with treated brain metastases are eligible if they are clinically stable wit...
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Cixutumumab is an investigational monoclonal antibody being studied for the treatment of oncology conditions, including tumors, non-small-cell lung carcinoma, and carcinoma. It has been evaluated in clinical trials for islet cell cancer and neuroendocrine tumors, as well as advanced solid tumors. The drug is not approved and remains in clinical development.
Cixutumumab is a monoclonal antibody. Its specific molecular target is not disclosed in the available information. The drug is being investigated for its potential role in treating various cancers, including non-small-cell lung carcinoma and neuroendocrine tumors, but its mechanism of action has not been detailed.
Cixutumumab is developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company has sponsored clinical trials to evaluate the drug's safety and efficacy in patients with various types of cancer.
Cixutumumab is in Phase 2 clinical development. It has completed multiple trials, including Phase 1 and Phase 2 studies. The drug is investigational and has not received FDA approval. Its development status is based on completed trials, with no active trials currently listed.
Cixutumumab has been studied in several clinical trials, including NCT00781911, a Phase 2 study in islet cell cancer with 43 participants, and NCT01007032, a Phase 1 study in advanced solid tumors with 21 participants. The largest trial, NCT01232452, was a Phase 2 study in non-small-cell lung carcinoma with 172 participants.
Yes, Cixutumumab is also known as IMC-A12. Clinical trial records refer to the drug by both names, with studies titled 'A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer' and 'A Study of IMC-A12 in Advanced Solid Tumors.' Both names refer to the same investigational monoclonal antibody.