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Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants
Phase 2 trial testing VS-6063 in Malignant Pleural Mesothelioma in 35 participants. Terminated before completion.
| Lead sponsor | Verastem, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 12 December 2013 |
| Primary completion | 19 June 2019 |
| Estimated completion | 19 June 2019 |
| Sites | 1 location across United States |
Verastem, Inc. — full company profile →
18 and older, any sex, with Malignant Pleural Mesothelioma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
percentage VS-6063 (defactinib)
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | NA | NA – NA |
| Cohort 2 | NA | NA – NA |
| Cohort 3 | 85.6 | -12.57 – 100 |
| Cohort 4 | NA | NA – NA |
Maximum observed plasma concentration
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 1052 | ± 126 |
| Cohort 2 | 1052 | ± 126 |
| Cohort 3 (Fed) | 513 | ± 180 |
| Cohort 4 (Fasted) | 517 | ± 76 |
Area under plasma Concentration (AUC) 0 to t
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 5280 | ± 136 |
| Cohort 2 (Fasted) | 5280 | ± 136 |
| Cohort 3 (Fed) | 2753 | ± 198 |
| Cohort 4 (Fasted) | 1891 | ± 69 |
Time to Maximum concentration (Tmax)
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 1 | 1 – 4 |
| Cohort 2 | 1 | 1 – 4 |
| Cohort 3 (Fed) | 4 | 2 – 8 |
| Cohort 4 (Fasted) | 1 | 1 – 2 |
Adverse events will be graded by the CTCAE (Common Terminology Criteria for Adverse Events) 4.0 and summarized according to the worst grade observed since the first treatment dose.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 10 | |
| Cohort 2 | 10 | |
| Cohort 3 | 10 | |
| Cohort 4 | 5 |
Modified RECIST criteria for assessment of response in malignant pleural mesothelioma Ann Oncol 2004. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the in the volume of target lesions; Progressive Disease (PD) at least a 20% increase in the volume of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter.
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 0 | |
| Cohort 2 | 0 | |
| Cohort 3 | 0 | |
| Cohort 4 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 1 | |
| Cohort 2 | 2 | |
| Cohort 3 | 1 | |
| Cohort 4 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 9 | |
| Cohort 2 | 4 | |
| Cohort 3 | 7 | |
| Cohort 4 | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 0 | |
| Cohort 2 | 3 | |
| Cohort 3 | 2 | |
| Cohort 4 | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort 1 | 0 | |
| Cohort 2 | 1 | |
| Cohort 3 | 0 | |
| Cohort 4 | 0 |
Time frame: Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|---|
| International Normalised Ratio increased | Investigations | — | — | — | — |
| Disease progression | General disorders | — | — | — | — |
| Wound Infection | Infections and infestations | — | — | — | — |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | — | — | — | — |
| Abdominal hernia | Gastrointestinal disorders | — | — | — | — |
| Reaction | System | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Hyperbilirubinaemia | Hepatobiliary disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Night Sweats | Skin and subcutaneous tissue disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Upper Respiratory Infection | Infections and infestations | — | — | — | — |
| International normalised ratio increased | Investigations | — | — | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Tumor Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Injury, poisoning, procedureal complications | Injury, poisoning and procedural complications | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Weight decreased | Investigations | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Tremor | Nervous system disorders | — | — | — | — |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
Most-reported serious reactions: International Normalised Ratio increased, Disease progression, Wound Infection, Metastases to central nervous system, Disseminated intravascular coagulation, Abdominal hernia.
Data from ClinicalTrials.gov NCT02004028 adverse events section.
This is an open label neoadjuvant (treatment with VS-6063 prior to mesothelioma surgery) study in subjects with malignant pleural mesothelioma who are eligible for surgery. Subjects will receive VS-6063 (defactinib) 400 mg twice daily for 12, 21, or 35 days or 100 mg formulation twice daily for 21 days. Pre- and post-treatment biopsies and blood samples will be collected. The purpose of this study is to assess biomarker responses from tumor tissue. The safety, pharmacokinetics, and tumor response rate to VS-6063 (defactinib) will be also be assessed.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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