A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.
Sponsor
Bayer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00678288
Collaborator
(none)
16
35
2
14
0.5
0
Study Details
Study Description
Brief Summary
This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Randomized, Open-label, Multicenter, Study Evaluating the Efficacy of Sorafenib Alone and Sorafenib in Combination With Low Dose Interferon Alpha-2a as Second-line Treatment of Sunitinib Failure in Patients With Metastatic Renal Cell Carcinoma
Study Start Date
:
Apr 1, 2008
Actual Primary Completion Date
:
Jun 1, 2009
Actual Study Completion Date
:
Jun 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sorafenib (Nexavar, BAY43-9006) Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. |
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously
|
| Experimental: Sorafenib (Nexavar, BAY43-9006) + Interferon Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. |
Drug: Sorafenib (Nexavar, BAY43-9006) + Interferon
Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously. IFN alpha-2a 3MIU FIW s.c., from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival [From start of treatment of the first subject until 14 months later, assessed every 8 weeks]
Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.
Secondary Outcome Measures
- Response Rate [From start of treatment of the first subject until 14 months later, assessed every 8 Weeks]
Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Time to Progression [From start of treatment of the first subject until 14 months later, assessed every 8 Weeks]
Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
- Duration of Response [From start of treatment of the first subject until 14 months later, assessed every 8 Weeks]
Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.
- Overall Survival [From start of treatment of the first subject until 14 months later, assessed every 8 Weeks]
Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment)
-
And/or patients who have discontinued sunitinib treatment at any point due to toxicity
-
Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks
-
Memorial Sloane Kettering Cancer Centre (MSKCC) prognostic score low or intermediate
-
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
-
Patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%).
Exclusion Criteria:
-
Patient should be excluded if they have unresolved chronic toxicity grade
-
1 and related to prior therapy with sunitinib.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Salzburg | Austria | 5020 | ||
| 2 | Wien | Austria | 1090 | ||
| 3 | Avignon | France | 84000 | ||
| 4 | Bayonne | France | 64100 | ||
| 5 | Bordeaux | France | 33000 | ||
| 6 | Marseille | France | 13015 | ||
| 7 | Marseille | France | 13385 | ||
| 8 | Nantes | France | 44020 | ||
| 9 | Paris | France | 75014 | ||
| 10 | Paris | France | 75651 | ||
| 11 | Reims | France | 51100 | ||
| 12 | Strasbourg | France | 67000 | ||
| 13 | Toulouse | France | 31052 | ||
| 14 | Vandoeuvre Les Nancy | France | 54000 | ||
| 15 | Cork | Ireland | |||
| 16 | Dublin | Ireland | 24 | ||
| 17 | Aviano | Pordenone | Italy | 33081 | |
| 18 | Legnago | Verona | Italy | 37045 | |
| 19 | Napoli | Italy | 80131 | ||
| 20 | Pavia | Italy | 27100 | ||
| 21 | Perugia | Italy | 06156 | ||
| 22 | Reggio Emilia | Italy | 42100 | ||
| 23 | Gdansk | Poland | 80-219 | ||
| 24 | Lublin | Poland | 20-090 | ||
| 25 | Warszawa | Poland | 04-141 | ||
| 26 | Wroclaw | Poland | 50 - 556 | ||
| 27 | Barcelona | Spain | 08035 | ||
| 28 | Madrid | Spain | 28041 | ||
| 29 | Madrid | Spain | 28046 | ||
| 30 | Oviedo | Spain | 33006 | ||
| 31 | Pamplona | Spain | 31008 | ||
| 32 | Valencia | Spain | 46009 | ||
| 33 | Northwood | Middlesex | United Kingdom | HA6 2RN | |
| 34 | Newcastle Upon Tyne | Tyne and Wear | United Kingdom | NE4 6BE | |
| 35 | London | United Kingdom | SW3 6JJ |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00678288
Other Study ID Numbers:
- 12782
- 2007-005083-28
- CONCERT
First Posted:
May 15, 2008
Last Update Posted:
Dec 11, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Bayer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This study was conducted from 16 Apr 2008 to 26 Jun 2009 at 31 centers in 7 countries: France (11), Italy (6), Spain (5), Poland (4), Ireland (2), United Kingdom (2), and Austria (1). The planned enrollment was 120 subjects in the 2 treatment groups (60 subjects per group). The study was stopped early because of slow accrual. |
|---|---|
| Pre-assignment Detail | A total of 24 subjects were screened; 16 were enrolled and randomized; 10 (63%) to sorafenib alone and 6 (37%) to sorafenib + interferon. All 16 randomized subjects received at least 1 dose of study drug and were included in the safety analysis population. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) + Interferon |
|---|---|---|
| Arm/Group Description | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. |
| Period Title: Overall Study | ||
| STARTED | 10 | 6 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 10 | 6 |
Baseline Characteristics
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) + Interferon | Total |
|---|---|---|---|
| Arm/Group Description | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. | Total of all reporting groups |
| Overall Participants | 10 | 6 | 16 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
57
|
60.5
|
58.5
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
30%
|
4
66.7%
|
7
43.8%
|
| Male |
7
70%
|
2
33.3%
|
9
56.3%
|
| Memorial Sloane Kettering Cancer Center (MSKCC) score (participants) [Number] | |||
| low MSKCC score |
3
30%
|
1
16.7%
|
4
25%
|
| intermediate MSKCC score |
7
70%
|
5
83.3%
|
12
75%
|
Outcome Measures
| Title | Progression-Free Survival |
|---|---|
| Description | Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation. |
| Time Frame | From start of treatment of the first subject until 14 months later, assessed every 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) + Interferon |
|---|---|---|
| Arm/Group Description | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. |
| Measure Participants | 0 | 0 |
| Title | Response Rate |
|---|---|
| Description | Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. |
| Time Frame | From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) + Interferon |
|---|---|---|
| Arm/Group Description | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. |
| Measure Participants | 0 | 0 |
| Title | Time to Progression |
|---|---|
| Description | Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. |
| Time Frame | From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) + Interferon |
|---|---|---|
| Arm/Group Description | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. |
| Measure Participants | 0 | 0 |
| Title | Duration of Response |
|---|---|
| Description | Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact. |
| Time Frame | From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) + Interferon |
|---|---|---|
| Arm/Group Description | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. |
| Measure Participants | 0 | 0 |
| Title | Overall Survival |
|---|---|
| Description | Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact. |
| Time Frame | From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) + Interferon |
|---|---|---|
| Arm/Group Description | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST) | |||
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) + Interferon | ||
| Arm/Group Description | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. | ||
All Cause Mortality |
||||
| Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) + Interferon | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) + Interferon | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/10 (50%) | 3/6 (50%) | ||
| General disorders | ||||
| Fatigue | 1/10 (10%) | 2/6 (33.3%) | ||
| Pain, bone | 1/10 (10%) | 0/6 (0%) | ||
| Pain, back | 0/10 (0%) | 1/6 (16.7%) | ||
| Infections and infestations | ||||
| Infection (documented clinically), bronchus | 1/10 (10%) | 0/6 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Fracture | 1/10 (10%) | 1/6 (16.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnea (shortness of breath) | 1/10 (10%) | 0/6 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Sorafenib (Nexavar, BAY43-9006) | Sorafenib (Nexavar, BAY43-9006) + Interferon | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/10 (90%) | 5/6 (83.3%) | ||
| Blood and lymphatic system disorders | ||||
| Neutrophils | 1/10 (10%) | 0/6 (0%) | ||
| Hemoglobin | 1/10 (10%) | 1/6 (16.7%) | ||
| Platelets | 1/10 (10%) | 2/6 (33.3%) | ||
| Leukocytes | 1/10 (10%) | 0/6 (0%) | ||
| Cardiac disorders | ||||
| Hypertension | 2/10 (20%) | 0/6 (0%) | ||
| Ear and labyrinth disorders | ||||
| Tinnitus | 1/10 (10%) | 0/6 (0%) | ||
| Auditory/ear - ohter | 0/10 (0%) | 1/6 (16.7%) | ||
| Endocrine disorders | ||||
| Hypothyroidism | 0/10 (0%) | 1/6 (16.7%) | ||
| Gastrointestinal disorders | ||||
| Anorexia | 2/10 (20%) | 2/6 (33.3%) | ||
| Diarrhea | 5/10 (50%) | 3/6 (50%) | ||
| Mucositis (functional/symptomatic), esophagus | 1/10 (10%) | 0/6 (0%) | ||
| Mucositis (functional/symptomatic), oral cavity | 2/10 (20%) | 1/6 (16.7%) | ||
| Mucositis (functional/symptomatic), pharynx | 1/10 (10%) | 0/6 (0%) | ||
| Nausea | 1/10 (10%) | 3/6 (50%) | ||
| Taste alteration | 1/10 (10%) | 0/6 (0%) | ||
| Vomiting | 2/10 (20%) | 2/6 (33.3%) | ||
| Constipation | 0/10 (0%) | 1/6 (16.7%) | ||
| Dehydration | 0/10 (0%) | 1/6 (16.7%) | ||
| General disorders | ||||
| Fatigue | 7/10 (70%) | 3/6 (50%) | ||
| Weight loss | 1/10 (10%) | 0/6 (0%) | ||
| Pain, back | 1/10 (10%) | 1/6 (16.7%) | ||
| Pain, chest/thorax NOS | 2/10 (20%) | 0/6 (0%) | ||
| Pain, chest wall | 1/10 (10%) | 0/6 (0%) | ||
| Pain, abdomen NOS | 4/10 (40%) | 0/6 (0%) | ||
| Pain, head/headache | 1/10 (10%) | 1/6 (16.7%) | ||
| Pain, joint | 1/10 (10%) | 0/6 (0%) | ||
| Pain, bone | 1/10 (10%) | 1/6 (16.7%) | ||
| Fever | 0/10 (0%) | 2/6 (33.3%) | ||
| Insomnia | 0/10 (0%) | 1/6 (16.7%) | ||
| Constitutional symptoms - other | 0/10 (0%) | 1/6 (16.7%) | ||
| Pain, muscle | 0/10 (0%) | 1/6 (16.7%) | ||
| Immune system disorders | ||||
| Rhinitis | 1/10 (10%) | 0/6 (0%) | ||
| Infections and infestations | ||||
| Infection (documented clinically), bronchus | 1/10 (10%) | 0/6 (0%) | ||
| Infection (documented clinically), dental-tooth | 1/10 (10%) | 0/6 (0%) | ||
| Infection (documented clinically), bladder (urinary) | 0/10 (0%) | 1/6 (16.7%) | ||
| Infection (documented clinically), mucosa | 0/10 (0%) | 1/6 (16.7%) | ||
| Metabolism and nutrition disorders | ||||
| Metabolic/lab - other | 1/10 (10%) | 1/6 (16.7%) | ||
| ALT | 0/10 (0%) | 1/6 (16.7%) | ||
| AST | 0/10 (0%) | 1/6 (16.7%) | ||
| Hyperkalemia | 0/10 (0%) | 2/6 (33.3%) | ||
| Hyperglycemia | 0/10 (0%) | 1/6 (16.7%) | ||
| Hyperuricemia | 0/10 (0%) | 3/6 (50%) | ||
| Hypocalcemia | 0/10 (0%) | 1/6 (16.7%) | ||
| Hyponatremia | 0/10 (0%) | 1/6 (16.7%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Extremity-upper (function) | 1/10 (10%) | 0/6 (0%) | ||
| Nervous system disorders | ||||
| Mood alteration, depression | 1/10 (10%) | 0/6 (0%) | ||
| Neuropathy: sensory | 1/10 (10%) | 1/6 (16.7%) | ||
| Cognitive disturbance | 0/10 (0%) | 1/6 (16.7%) | ||
| Reproductive system and breast disorders | ||||
| Libido | 1/10 (10%) | 0/6 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 2/10 (20%) | 0/6 (0%) | ||
| Dyspnea (shortness of breath) | 2/10 (20%) | 2/6 (33.3%) | ||
| Voice changes | 1/10 (10%) | 0/6 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Dermal change | 1/10 (10%) | 0/6 (0%) | ||
| Alopecia | 2/10 (20%) | 0/6 (0%) | ||
| Hand-foot skin reaction | 5/10 (50%) | 0/6 (0%) | ||
| Dermatology - other | 2/10 (20%) | 0/6 (0%) | ||
| Photosensitivity | 1/10 (10%) | 0/6 (0%) | ||
| Pruritus | 1/10 (10%) | 1/6 (16.7%) | ||
| Rash/desquamation | 5/10 (50%) | 3/6 (50%) | ||
| Flushing | 2/10 (20%) | 0/6 (0%) | ||
| Dry skin | 0/10 (0%) | 1/6 (16.7%) | ||
| Erythema multiforme | 0/10 (0%) | 2/6 (33.3%) | ||
| Vascular disorders | ||||
| Thrombosis/thrombus/embolism | 1/10 (10%) | 0/6 (0%) | ||
| Hematoma | 0/10 (0%) | 1/6 (16.7%) | ||
| Hemorrhage pulmonary, nose | 0/10 (0%) | 1/6 (16.7%) | ||
Limitations/Caveats
The study was terminated early by the Sponsor due to low accrual. No efficacy analyses were performed.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Protocol and PI clinical trial agreements.
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | BAYER |
| Phone | |
| clinical-trials-contact@bayerhealthcare.com |
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00678288
Other Study ID Numbers:
- 12782
- 2007-005083-28
- CONCERT
First Posted:
May 15, 2008
Last Update Posted:
Dec 11, 2014
Last Verified:
Nov 1, 2014