Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
This study is ongoing, but not recruiting participants.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01103323
First received: April 8, 2010
Last updated: April 12, 2013
Last verified: April 2013
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Results First Received: October 19, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Metastatic Colorectal Cancer |
| Interventions: |
Drug: Regorafenib (Stivarga, BAY73-4506) Drug: Placebo |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle |
| Placebo | Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle |
Participant Flow: Overall Study
| Regorafenib (Stivarga, BAY73-4506) | Placebo | |
|---|---|---|
| STARTED | 505 | 255 |
| Participants Received Treatment | 500 | 253 |
| COMPLETED | 386 | 232 |
| NOT COMPLETED | 119 | 23 |
| Adverse Event | 42 | 7 |
| Withdrawal by Subject | 16 | 5 |
| Protocol Violation | 2 | 0 |
| Physician Decision | 2 | 0 |
| ongoing with treatment | 52 | 9 |
| did not receive study treatment | 5 | 2 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle |
| Placebo | Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle |
| Total | Total of all reporting groups |
Baseline Measures
| Regorafenib (Stivarga, BAY73-4506) | Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
505 | 255 | 760 |
|
Age
[1] [units: Years] Mean ( Full Range ) |
60.7
( 22 to 82 ) |
60.1
( 25 to 85 ) |
60.5
( 22 to 85 ) |
|
Gender
[units: Participants] |
|||
| Female | 194 | 102 | 296 |
| Male | 311 | 153 | 464 |
|
Eastern Cooperative Oncology Group (ECOG) performance status (PS) before treatment
[2] [units: Participants] |
|||
| 0 | 265 | 146 | 411 |
| 1 | 240 | 109 | 349 |
|
KRAS mutation
[3] [units: Participants] |
|||
| No | 205 | 94 | 299 |
| Yes | 273 | 157 | 430 |
| Unknown | 27 | 4 | 31 |
| [1] | The age of the patient in years at enrollment in the study. |
|---|---|
| [2] | ECOG PS is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst). 0=Fully active without restriction; 1= Restricted in physically strenuous activity; 2= Ambulatory, capable of all selfcare; 3= Capable of limited selfcare; 4= Completely disabled; 5= Dead |
| [3] | KRAS - Kirsten rat sarcoma viral oncogene homolog (protein), member of the RAS family of GTPases (guanosine triphosphate hydrolases) |
Outcome Measures
| 1. Primary: | Overall Survival [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA). ] |
| 2. Secondary: | Progression-free Survival (Based on Investigator’s Assessment) [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ] |
| 3. Secondary: | Objective Tumor Response [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ] |
| 4. Secondary: | Disease Control [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ] |
| 5. Secondary: | Tumor Response [ Time Frame: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals. ] |
Serious Adverse Events Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
|---|
Reporting Groups
| Description | |
|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle |
| Placebo | Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle |
Other Adverse Events
| Regorafenib (Stivarga, BAY73-4506) | Placebo | |
|---|---|---|
| Total, other (not including serious) adverse events | ||
| # participants affected / at risk | 489/500 | 228/253 |
| Blood and lymphatic system disorders | ||
| Edema: Limb * 1 | ||
| # participants affected / at risk | 46/500 (9.20%) | 16/253 (6.32%) |
| # events | 53 | 19 |
| Hemoglobin * 1 | ||
| # participants affected / at risk | 70/500 (14.00%) | 28/253 (11.07%) |
| # events | 127 | 45 |
| Platelets * 1 | ||
| # participants affected / at risk | 77/500 (15.40%) | 6/253 (2.37%) |
| # events | 125 | 9 |
| Cardiac disorders | ||
| Hypertension * 1 | ||
| # participants affected / at risk | 152/500 (30.40%) | 20/253 (7.91%) |
| # events | 207 | 22 |
| Gastrointestinal disorders | ||
| Anorexia * 1 | ||
| # participants affected / at risk | 234/500 (46.80%) | 72/253 (28.46%) |
| # events | 352 | 95 |
| Constipation * 1 | ||
| # participants affected / at risk | 119/500 (23.80%) | 48/253 (18.97%) |
| # events | 146 | 58 |
| Diarrhea * 1 | ||
| # participants affected / at risk | 214/500 (42.80%) | 44/253 (17.39%) |
| # events | 436 | 57 |
| Mucositis (Functional/Symptomatic), Oral Cavity * 1 | ||
| # participants affected / at risk | 144/500 (28.80%) | 12/253 (4.74%) |
| # events | 257 | 12 |
| Nausea * 1 | ||
| # participants affected / at risk | 112/500 (22.40%) | 55/253 (21.74%) |
| # events | 149 | 67 |
| Taste Alteration * 1 | ||
| # participants affected / at risk | 37/500 (7.40%) | 6/253 (2.37%) |
| # events | 40 | 6 |
| Vomiting * 1 | ||
| # participants affected / at risk | 80/500 (16.00%) | 41/253 (16.21%) |
| # events | 112 | 50 |
| General disorders | ||
| Constitutional Symptoms - Other * 1 | ||
| # participants affected / at risk | 29/500 (5.80%) | 17/253 (6.72%) |
| # events | 36 | 19 |
| Fatigue * 1 | ||
| # participants affected / at risk | 316/500 (63.20%) | 116/253 (45.85%) |
| # events | 584 | 168 |
| Fever * 1 | ||
| # participants affected / at risk | 133/500 (26.60%) | 39/253 (15.42%) |
| # events | 183 | 47 |
| Flu-Like Syndrome * 1 | ||
| # participants affected / at risk | 25/500 (5.00%) | 6/253 (2.37%) |
| # events | 28 | 8 |
| Insomnia * 1 | ||
| # participants affected / at risk | 39/500 (7.80%) | 14/253 (5.53%) |
| # events | 43 | 15 |
| Pain, Abdomen NOS * 1 | ||
| # participants affected / at risk | 118/500 (23.60%) | 47/253 (18.58%) |
| # events | 194 | 53 |
| Pain, Back * 1 | ||
| # participants affected / at risk | 74/500 (14.80%) | 24/253 (9.49%) |
| # events | 107 | 26 |
| Pain, Extremity - Limb * 1 | ||
| # participants affected / at risk | 47/500 (9.40%) | 14/253 (5.53%) |
| # events | 77 | 19 |
| Pain, Head/Headache * 1 | ||
| # participants affected / at risk | 50/500 (10.00%) | 18/253 (7.11%) |
| # events | 63 | 23 |
| Pain, Joint * 1 | ||
| # participants affected / at risk | 31/500 (6.20%) | 13/253 (5.14%) |
| # events | 32 | 14 |
| Pain, Muscle * 1 | ||
| # participants affected / at risk | 49/500 (9.80%) | 14/253 (5.53%) |
| # events | 63 | 16 |
| Weight Loss * 1 | ||
| # participants affected / at risk | 162/500 (32.40%) | 28/253 (11.07%) |
| # events | 220 | 32 |
| Metabolism and nutrition disorders | ||
| ALT * 1 | ||
| # participants affected / at risk | 27/500 (5.40%) | 5/253 (1.98%) |
| # events | 49 | 5 |
| AST * 1 | ||
| # participants affected / at risk | 35/500 (7.00%) | 9/253 (3.56%) |
| # events | 67 | 9 |
| Alkaline Phosphatase * 1 | ||
| # participants affected / at risk | 32/500 (6.40%) | 8/253 (3.16%) |
| # events | 44 | 12 |
| Bilirubin (Hyperbilirubinemia) * 1 | ||
| # participants affected / at risk | 95/500 (19.00%) | 22/253 (8.70%) |
| # events | 156 | 37 |
| Hypocalcemia * 1 | ||
| # participants affected / at risk | 33/500 (6.60%) | 1/253 (0.40%) |
| # events | 51 | 1 |
| Hypokalemia * 1 | ||
| # participants affected / at risk | 46/500 (9.20%) | 5/253 (1.98%) |
| # events | 58 | 6 |
| Hyponatremia * 1 | ||
| # participants affected / at risk | 29/500 (5.80%) | 6/253 (2.37%) |
| # events | 40 | 10 |
| Hypophosphatemia * 1 | ||
| # participants affected / at risk | 32/500 (6.40%) | 2/253 (0.79%) |
| # events | 55 | 3 |
| Lipase * 1 | ||
| # participants affected / at risk | 31/500 (6.20%) | 3/253 (1.19%) |
| # events | 70 | 4 |
| Metabolic/Lab - Other * 1 | ||
| # participants affected / at risk | 37/500 (7.40%) | 8/253 (3.16%) |
| # events | 60 | 14 |
| Proteinuria * 1 | ||
| # participants affected / at risk | 40/500 (8.00%) | 6/253 (2.37%) |
| # events | 89 | 11 |
| Nervous system disorders | ||
| Dizziness * 1 | ||
| # participants affected / at risk | 26/500 (5.20%) | 13/253 (5.14%) |
| # events | 29 | 13 |
| Neuropathy: Sensory * 1 | ||
| # participants affected / at risk | 50/500 (10.00%) | 25/253 (9.88%) |
| # events | 66 | 27 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough * 1 | ||
| # participants affected / at risk | 55/500 (11.00%) | 28/253 (11.07%) |
| # events | 76 | 32 |
| Dyspnea (Shortness Of Breath) * 1 | ||
| # participants affected / at risk | 85/500 (17.00%) | 33/253 (13.04%) |
| # events | 103 | 45 |
| Voice Changes * 1 | ||
| # participants affected / at risk | 160/500 (32.00%) | 16/253 (6.32%) |
| # events | 205 | 17 |
| Skin and subcutaneous tissue disorders | ||
| Alopecia * 1 | ||
| # participants affected / at risk | 39/500 (7.80%) | 4/253 (1.58%) |
| # events | 43 | 4 |
| Dermatology - Other * 1 | ||
| # participants affected / at risk | 29/500 (5.80%) | 6/253 (2.37%) |
| # events | 43 | 8 |
| Dry Skin * 1 | ||
| # participants affected / at risk | 50/500 (10.00%) | 10/253 (3.95%) |
| # events | 59 | 11 |
| Hand-Foot Skin Reaction * 1 | ||
| # participants affected / at risk | 234/500 (46.80%) | 19/253 (7.51%) |
| # events | 685 | 21 |
| Pruritus * 1 | ||
| # participants affected / at risk | 27/500 (5.40%) | 11/253 (4.35%) |
| # events | 36 | 11 |
| Rash/Desquamation * 1 | ||
| # participants affected / at risk | 142/500 (28.40%) | 13/253 (5.14%) |
| # events | 207 | 17 |
| Vascular disorders | ||
| Hemorrhage Pulmonary, Nose * 1 | ||
| # participants affected / at risk | 45/500 (9.00%) | 6/253 (2.37%) |
| # events | 54 | 6 |
| * | Events were collected by non-systematic assessment |
|---|---|
| 1 | Term from vocabulary, NCI-CTCAE v.3.0 |