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Study to Evaluate Mechanisms of Acquired Resistance to Panitumumab
Phase 2 trial testing Panitumumab in Metastatic Colorectal Cancer in 74 participants. Completed in 22 July 2013.
| Lead sponsor | NantBioScience, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 74 |
| Start date | 5 May 2009 |
| Primary completion | 22 July 2013 |
| Estimated completion | 22 July 2013 |
NantBioScience, Inc. — full company profile →
18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
KRAS mutation status changed from wild-type at baseline to mutant at time of second biopsy in part 1, as measured by the PFS hazard ratio. Hazard ratio is presented as wild-type: mutant
| Group | Value | 95% CI |
|---|---|---|
| Part 1 | 0.365 | 0.164 – 0.808 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Part 2 | 0.00 | 0.00 – 9.74 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Part 1 | 21.62 | 12.89 – 32.72 |
Time from the first dose of investigational product to the first date of disease progression per the modified RECIST v1.0 or death by any cause, initiating a new line of antitumor therapy, or receiving study treatment in Part 2, whichever is earlier in Part 1. Disease progression is a \>= 20% increase in the sum of the longest diameter of the target lesions as compared to the smallest sum while on study per RECIST v1.0
| Group | Value | 95% CI |
|---|---|---|
| Panitumumab | 4.6 | 3.7 – 6.9 |
Time from the start of Part 2 to the first date of disease progression per the modified RECIST v1.0 or death by any cause, initiating a new line of antitumor therapy, or receiving study treatment in Part 2, whichever is earlier. Disease progression is a \>= 20% increase in the sum of the longest diameter of the target lesions as compared to the smallest sum while on study per RECIST v1.0.
| Group | Value | 95% CI |
|---|---|---|
| Panitumumab | 1.7 | 1.6 – 1.8 |
Time from the first dose of investigational product to death from any cause in Part 1.
| Group | Value | 95% CI |
|---|---|---|
| Panitumumab | 11.6 | 7.8 – 12.9 |
Time from the start of Part 2 to death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Panitumumab | 7.6 | 5.6 – 12.3 |
Time from the first dose of investigational product to the date of first confirmed objective response in Part 1. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Panitumumab | 2.0 | ± 0.4 |
Time from first confirmed objective response to disease progression per modified RECIST v1.0 in Part 1. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR; Disease progression is a \>= 20% increase in the sum of the longes
| Group | Value | 95% CI |
|---|---|---|
| Panitumumab | 7.7 | 6.7 – 9.1 |
Time frame: Part 1: All-Cause Mortality was assessed up to 152 weeks and all other adverse events were collected up to 79 weeks; Part 2: All-Cause Mortality was assessed from start of part 2 up to 119 weeks from time of randomization and all other adverse events were collected up to 41 weeks from time of randomization.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Part 1 Panitumumab + Irino… | Part 2 Panitumumab + AMG479 |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| General physical health deterioration | General disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Cholangitis | Hepatobiliary disorders | — | — |
| Device related infection | Infections and infestations | — | — |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Confusional state | Psychiatric disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Cardiac failure | Cardiac disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Ileus | Gastrointestinal disorders | — | — |
| Oesophagitis | Gastrointestinal disorders | — | — |
| Rectal haemorrhage | Gastrointestinal disorders | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Performance status decreased | General disorders | — | — |
| Cholestasis | Hepatobiliary disorders | — | — |
| Hypersensitivity | Immune system disorders | — | — |
| Anal abscess | Infections and infestations | — | — |
| Bronchitis | Infections and infestations | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Reaction | System | Part 1 Panitumumab + Irino… | Part 2 Panitumumab + AMG479 |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Decreased Appetite | Metabolism and nutrition disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Mucosal Inflammation | General disorders | — | — |
| Dry Skin | Skin and subcutaneous tissue disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Skin Fissures | Skin and subcutaneous tissue disorders | — | — |
| Abdominal Pain | General disorders | — | — |
| Paronychia | Psychiatric disorders | — | — |
| Skin Toxicity | Skin and subcutaneous tissue disorders | — | — |
| Fatigue | General disorders | — | — |
| Pruritus | General disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Pyrexia | General disorders | — | — |
| Acne | Skin and subcutaneous tissue disorders | — | — |
| General Physical Health Deterioration | General disorders | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — |
| Conjunctivitis | Eye disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Weight Decreased | Investigations | — | — |
| Abdominal Pain Upper | General disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Xerosis | General disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Folliculitis | Skin and subcutaneous tissue disorders | — | — |
| Headache | General disorders | — | — |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | — | — |
| Urinary Tract Infection | Renal and urinary disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Dysgeusia | Renal and urinary disorders | — | — |
| Erythema | General disorders | — | — |
Most-reported serious reactions: Diarrhoea, General physical health deterioration, Vomiting, Asthenia, Anaemia, Neutropenia, Intestinal obstruction, Fatigue.
Data from ClinicalTrials.gov NCT00891930 adverse events section.
This study is designed to evaluate the mechanism(s) of resistance to the anti-epidermal growth factor receptor (EGFR) antibody panitumumab given in combination with irinotecan in metastatic colorectal carcinoma (mCRC) patients with wild-type Kirsten rat sarcoma-2 virus oncogene (KRAS) tumor status at the time of initial diagnosis.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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