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NCT01160458

Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy

Completed Phase 2 Results posted Last updated 10 April 2018
What this trial tests

Phase 2 trial testing IMC-A12 in Pleural Mesothelioma in 20 participants. Completed in 24 February 2017.

Timeline
2 June 2010
Primary endpoint
13 August 2016
24 February 2017

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date2 June 2010
Primary completion13 August 2016
Estimated completion24 February 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Pleural Mesothelioma or Peritoneal Mesothelioma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Response Rate (PR+CR) Primary · 36 months

Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Complete Response
GroupValue95% CI
IMC-A12 Monotherapy in Patients0
Partial Response
GroupValue95% CI
IMC-A12 Monotherapy in Patients0
Safety of IMC-A12 in Patients With Mesothelioma Secondary · Date treatment consent signed to date off study, approximately 36 months

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

GroupValue95% CI
IMC-A12 Monotherapy in Patients20
Progression Free Survival (PFS) Secondary · To study completion, an average of 3 years

Progression Free Survival is defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study longest diameter (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).

GroupValue95% CI
IMC-A12 Monotherapy in Patients1.81.4 – 5.5
Overall Survival (OS) Secondary · To study completion, an average of 3 years

Overall survival is the time interval from the start of treatment to the date of death.

GroupValue95% CI
IMC-A12 Monotherapy in Patients5.52.1 – 12.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Date treatment consent signed to date off study, approximately 36 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IMC-A12 Monotherapy in Patients
Serious: 19/20 (95%)
Deaths: 16/20

Serious adverse events (39 terms)

ReactionSystemIMC-A12 Monotherapy in Pat…
Death NOSGeneral disorders
FatigueGeneral disorders
Neoplasms benign, mailgnant and unspecified (incl cysts and polyps)-Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps)
AnorexiaMetabolism and nutrition disorders
DehydrationMetabolism and nutrition disorders
HypoalbuminemiaMetabolism and nutrition disorders
Abdominal painGastrointestinal disorders
AnemiaBlood and lymphatic system disorders
HyperkalemiaMetabolism and nutrition disorders
Weight lossInvestigations
Back painMusculoskeletal and connective tissue disorders
HypotensionVascular disorders
Alkaline phosphatase increasedInvestigations
Creatinine increasedInvestigations
DyspepsiaGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
HyperglycemiaMetabolism and nutrition disorders
HypocalcemiaMetabolism and nutrition disorders
HypophosphatemiaMetabolism and nutrition disorders
Lymphocyte count decreasedInvestigations
NauseaGastrointestinal disorders
SinusitisInfections and infestations
Abdominal distentionGastrointestinal disorders
Allergic rhinitisImmune system disorders
Atrial flutterCardiac disorders
Other adverse events (52 terms — click to expand)

ReactionSystemIMC-A12 Monotherapy in Pat…
HyperglycemiaMetabolism and nutrition disorders
Weight lossInvestigations
FatigueGeneral disorders
HyponatremiaMetabolism and nutrition disorders
HyperkalemiaMetabolism and nutrition disorders
Platelet count decreasedInvestigations
Creatinine increasedInvestigations
HypomagnesemiaMetabolism and nutrition disorders
VomitingGastrointestinal disorders
DizzinessNervous system disorders
Alkaline phosphatase increasedInvestigations
AnorexiaMetabolism and nutrition disorders
FloatersEye disorders
NauseaGastrointestinal disorders
AnemiaBlood and lymphatic system disorders
DiarrheaGastrointestinal disorders
DyspepsiaGastrointestinal disorders
InsomniaPsychiatric disorders
Lymphocyte count decreasedInvestigations
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
ConstipationGastrointestinal disorders
Dry mouthGastrointestinal disorders
DysgeusiaNervous system disorders
DyspneaRespiratory, thoracic and mediastinal disorders
FallInjury, poisoning and procedural complications
FeverGeneral disorders
HeadacheNervous system disorders
Nasal congestionRespiratory, thoracic and mediastinal disorders
Abdominal painGastrointestinal disorders
AlopeciaSkin and subcutaneous tissue disorders
BloatingGastrointestinal disorders
Blurred visionEye disorders
BruisingInjury, poisoning and procedural complications
ChillsGeneral disorders
Dry skinSkin and subcutaneous tissue disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
HypermagnesemiaMetabolism and nutrition disorders
HyperuricemiaMetabolism and nutrition disorders
HypoalbuminemiaMetabolism and nutrition disorders

Most-reported serious reactions: Death NOS, Fatigue, Neoplasms benign, mailgnant and unspecified (incl cysts and polyps)-Other, specify, Anorexia, Dehydration, Hypoalbuminemia, Abdominal pain, Anemia.

Data from ClinicalTrials.gov NCT01160458 adverse events section.

Sponsor's own description

Background: Background: \- IMC-A12, a new cancer treatment that has not yet been approved by the U.S. Food and Drug Administration, is an antibody that is designed to block the effects of a protein called Type I Insulin-Like Growth Factor (IGF-1R). IMC-A12 blocks the receptors in cells that respond to IGF-1R, which are thought to play an important role in helping cancer cells to grow and divide. Researchers are interested in determining whether IMC-A12 is an effective treatment for individuals who have mesothelioma that has not responded to standard chemotherapy. Objectives: \- To evaluate the safety and effectiveness of IMC-A12 treatment in individuals with mesothelioma who have previously had chemotherapy. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with mesothelioma that has not responded to chemotherapy. Design: * Eligible participants will be screened with a full physical examination and medical history, blood and urine samples, and imaging studies. * Participants will receive IMC-A12 once every 3 weeks (21-day cycle), and will be evaluated before the start of each new cycle with blood tests and imaging studies if needed. * Treatment cycles will continue for as long as needed, unless severe side effects develop or the disease progresses.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Malignant pleural mesothelioma: an update on diagnosis and treatment options.
    Kondola S, Manners D, Nowak AK. · · 2016 · cited 39× · PMID 26873306 · DOI 10.1177/1753465816628800
  2. Modulation of insulin-like growth factor-1 receptor and its signaling network for the treatment of cancer: current status and future perspectives.
    Jin M, Buck E, Mulvihill MJ. · · 2013 · cited 15× · PMID 25992224 · DOI 10.4081/oncol.2013.e3
  3. Phage displayed peptides/antibodies recognizing growth factors and their tyrosine kinase receptors as tools for anti-cancer therapeutics.
    Ronca R, Benzoni P, De Luca A, Crescini E, et al · · 2012 · cited 6× · PMID 22606042 · DOI 10.3390/ijms13045254
  4. Novel immunotherapy clinical trials in malignant pleural mesothelioma.
    Tano ZE, Chintala NK, Li X, Adusumilli PS. · · 2017 · cited 4× · PMID 28706913 · DOI 10.21037/atm.2017.03.81

Verify or expand the search:

Other trials of IMC-A12

Trials testing the same drug.

Other recruiting trials for Pleural Mesothelioma

Currently open trials in the same condition.

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01160458.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing