Carcinoma, Non-Small-Cell LungPhase 1NCT00979576
BIBF 1120 in Combination With Pemetrexed in Advanced Non Small Cell Lung Cancer (NSCLC)
A Phase 1 study testing BIBF 1120 M + Pemetrexed, BIBF 1120 H + Pemetrexed and BIBF 1120 RD + Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 3 sites in Japan.
Trial summary
The objectives of this trial are to estimate the following in Japanese patients with advanced NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy. Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD) of BIBF 1120 at a dose level up to twice daily… Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- BIBF 1120 M + Pemetrexed, BIBF 1120 H + Pemetrexed and BIBF 1120 RD + Pemetrexed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 3 sitesJapan
- Study dates
- 16 Oct 2009to 16 Feb 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients of age >=20 and <=74 years at informed consent
- Histologically or cytologically confirmed, Non Small Cell Lung Cancer (NSCLC) of stage IIIB or IV or recurrent NSCLC
- Relapse or failure of 1 first-line prior chemotherapy
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Patients who have sufficient baseline organ function over 4 weeks and whose laboratory data meet the following criteria at the enrolment
Show all 16Show fewer
- Haemoglobin >=9.0 g/dL
- Absolute neutrophil count (ANC) >=1500/mm^3
- Platelet count >=100 000/mm^3
- Total bilirubin under the upper limit of normal
- AST/SGOT and/or ALT/GPT <=1.5 x upper limit of normal (if related to liver metastases <=2.5 x upper limit of normal also)
- Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less
- Calculated creatinine clearance by Cockcroft Gault >=45 mL/min
- Prothrombin time-international normalized ratio (PT-INR) and/or partial thromboplastin time (PTT) greater than 50% deviation from normal limits
- arterial oxgen pressure (PaO2) >=60 torr or oxygen saturation by pulse-oximeter SpO2 >=92%
- Patient has given written informed consent which must be consistent with ICH-GCP and local legislation.
Who cannot join
- Patients who have received treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial or who have not recovered from side effects of such therapy (except for alopecia)
- Patients who have received chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug or who have not recovered from side effects of such therapy (except for alopecia) .
- Patients who have received radiotherapy within the following period Phase I part: the past 4 weeks prior to treatment with the trial drug (in case of palliative radiotherapy such as for extremities, within the past 2 weeks prior to treatment with the trial drug)
- Previous therapy with other vascular endothelial growth factor receptor (VEGFR) inhibitors or vascular endothelial growth factor (VEGF) ligand inhibitors for treatment of NSCLC
- Previous therapy with BIBF 1120 and/or pemetrexed for treatment of NSCLC and any contraindications for therapy with pemetrexed
- Patients who have active brain metastases
Show all 32Show fewer
- Leptomeningeal disease
- Patients with distinct or suspected pulmonary fibrosis or interstitial lung disease by the CT findings, or patients with a previous history of pulmonary fibrosis or interstitial lung disease (except irradiation-pneumonitis appearing radiation field with past radiotherapy).
- Radiographic evidence of cavitary or necrotic tumors
- Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
- History of clinically significant haemoptysis within the past 3 months
- History of major thrombotic or clinically relevant major bleeding event in the past 6 months
- Known inherited predisposition to bleeding or thrombosis
- Significant cardiovascular diseases
- Significant weight loss (>10%) within the past 6 weeks prior to treatment in the present trial
- Current peripheral neuropathy CTCAE grade 2 or greater except due to trauma
- Pre-existing ascites and/or clinically significant pleural effusion
- Major injuries and/or surgery within the past 4 weeks prior to randomisation with incomplete wound healing
- Clinically serious infections
- Decompensated diabetes mellitus
- Contraindication to high dose steroid therapy
- Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
- Patients who have active or chronic hepatitis C and/or B infection and diagnosis of human immunodeficiency virus (HIV) infection
- Other malignancy other than basal cell skin cancer, carcinoma in situ or intra-mucosal cancer that were judged to be cured by adequate treatment and disease-free interval is more than 5 years
- History of serious drug hypersensitivity
- Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation
- Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or breast feeding
- Active alcohol or drug abuse
- Patients unable to comply with the protocol
- Other patients judged ineligible for enrolment in the study by the investigator or subinvestigator.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
1199.28.003 Boehringer Ingelheim Investigational Site
Chiba,Kashiwa
1199.28.002 Boehringer Ingelheim Investigational Site
Miyakojima-ku, Osaka
1199.28.001 Boehringer Ingelheim Investigational Site
Osaka-Sayama, Osaka
About this study
Official title: A Phase I/II Study of Continuous, Concomitant Oral Treatment With BIBF 1120 and Pemetrexed - a Phase I, Open-label, Dose-escalation Study & a Phase II, 2 Arm, Randomized, Double-blind, Placebo-controlled Study in Japanese Patients With Stage IIIB/IV or Recurrent Non-small-cell Lung Cancer After Failure of Chemotherapy
The objectives of this trial are to estimate the following in Japanese patients with advanced NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy.
Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD) of BIBF 1120 at a dose level up to twice daily 200 mg with standard dose of pemetrexed (500 mg/m^2) and to determine the Recommended Dose (RD) for the phase II part.
Phase II, to investigate the efficacy and safety of BIBF 1120 in combination with pemetrexed (500 mg/m^2) as compared to pemetrexed (500 mg/m^2) + placebo
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- BIBF 1120 M + Pemetrexed, BIBF 1120 H + Pemetrexed, BIBF 1120 RD + Pemetrexed, BIBF 1120 L + Pemetrexed, BIBF 1120 Placebo + Pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120 M + PemetrexedDrug
BIBF 1120 medium dose bid+ Pemetrexed 500 mg/m^2
BIBF 1120 H + PemetrexedDrug
BIBF 1120 high dose bid+ Pemetrexed 500 mg/m^2
BIBF 1120 RD + PemetrexedDrug
confirmed dose of BIBF 1120 bid + Pemetrexed 500 mg/m^2
BIBF 1120 L + PemetrexedDrug
BIBF 1120 low dose bid+ Pemetrexed 500 mg/m^2
BIBF 1120 Placebo + PemetrexedDrug
placebo BIBF 1120 bid + Pemetrexed 500 mg/m^2
| Study group | Role | What they receive |
|---|---|---|
| BIBF 1120 BID + Pemetrexed | Experimental | Phase I part: Find MTD by using low, medium or high BIBF 1120 twice daily and 500mg/m^2 pemetrexed once every 3 weeks Receives: Drug: BIBF 1120 M + Pemetrexed; Drug: BIBF 1120 H + Pemetrexed; Drug: BIBF 1120 L + Pemetrexed |
| BIBF 1120 BID (RD) + Pemetrexed | Experimental | PHase II part: Study arm Receives: Drug: BIBF 1120 RD + Pemetrexed |
| BIBF 1120 BID(Placebo) + Pemetrexed | Experimental | Phase II part: Comparator arm Receives: Drug: BIBF 1120 Placebo + Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities
Number of participants with dose limiting toxicity (DLT) in combination therapy of BIBF 1120 and pemetrexed during the first course
Measured: During the first course, 21 days
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses
Number of patients with adverse events according to worst Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.
CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE) or 5 (death related to AE).
Measured: Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days
Secondary outcomes (8)
Overall Response Rate
Number of participants with complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0
Measured: Every 6 weeks after start of study treatment until end of treatment, up to 992 days
Disease Control Rate
Number of participants with complete response (CR), partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0
Measured: Every 6 weeks after start of study treatment until end of treatment, up to 992 days
Duration of Disease Control
Duration of disease control was defined as the time period from the first study drug administration to the progressive disease (PD) or death of patients, whichever occurred earlier.
Measured: From first study drug administration until PD or death, up to 1003 days
Number of Participants With Clinically Relevant Abnormalities in Laboratory Parameters
Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events which occurred in >= 20% of patients
Measured: Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days
AUC0-inf of Nintedanib
Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Measured: 5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1
Cmax of Nintedanib
Maximum measured concentration of nintedanib in plasma (Cmax)
Measured: 5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1
AUC0-inf of Pemetrexed
Area under the concentration-time curve of pemetrexed in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Measured: 5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2
Cmax of Pemetrexed
Maximum measured concentration of pemetrexed in plasma (Cmax)
Measured: 5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study start16 Oct 2009
- Primary completion16 Feb 2015
- Study completion16 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979576
- Sponsor's protocol ID
- 1199.28
- Status last verified
- Mar 2025
- First submitted
- 17 Sep 2009
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Publications
Daga H, Takeda K, Okada H, Miyazaki M, Ueda S, Kaneda H, Okamoto I, Yoh K, Goto K, Konishi K, Sarashina A, Tanaka T, Kaiser R, Nakagawa K. Phase I study of nintedanib in combination with pemetrexed as second-line treatment of Japanese patients with advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2015 Dec;76(6):1225-33. doi: 10.1007/s00280-015-2896-3. Epub 2015 Nov 11.
PubMed 26560486
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Continuous, Concomitant Oral Treatment With BIBF 1120 and Pemetrexed - a Phase I, Open-label, Dose-escalation Study & a Phase II, 2 Arm, Randomized, Double-blind, Placebo-controlled Study in Japanese Patients With Stage IIIB/IV or Recurrent Non-small-cell Lung Cancer After Failure of Chemotherapy
- ClinicalTrials.gov ID
- NCT00979576
- Acronym / sponsor ID
- 1199.28
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2009 (actual)
- Primary completion
- 16 Feb 2015 (actual)
- Study completion
- 16 Feb 2015 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Posted 20 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this trial are to estimate the following in Japanese patients with advanced NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy.
Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD) of BIBF 1120 at a dose level up to twice daily 200 mg with standard dose of pemetrexed (500 mg/m^2) and to determine the Recommended Dose (RD) for the phase II part.
Phase II, to investigate the efficacy and safety of BIBF 1120 in combination with pemetrexed (500 mg/m^2) as compared to pemetrexed (500 mg/m^2) + placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIBF 1120 BID + Pemetrexed | Experimental | Drug: BIBF 1120 M + Pemetrexed, Drug: BIBF 1120 H + Pemetrexed, Drug: BIBF 1120 L + PemetrexedPhase I part: Find MTD by using low, medium or high BIBF 1120 twice daily and 500mg/m^2 pemetrexed once every 3 weeks |
| BIBF 1120 BID (RD) + Pemetrexed | Experimental | Drug: BIBF 1120 RD + PemetrexedPHase II part: Study arm |
| BIBF 1120 BID(Placebo) + Pemetrexed | Experimental | Drug: BIBF 1120 Placebo + PemetrexedPhase II part: Comparator arm |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female patients of age >=20 and <=74 years at informed consent
- Histologically or cytologically confirmed, Non Small Cell Lung Cancer (NSCLC) of stage IIIB or IV or recurrent NSCLC
- Relapse or failure of 1 first-line prior chemotherapy
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Key exclusion criteria (32 listed)
- Patients who have received treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial or who have not recovered from side effects of such therapy (except for alopecia)
- Patients who have received chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug or who have not recovered from side effects of such therapy (except for alopecia) .
- Patients who have received radiotherapy within the following period Phase I part: the past 4 weeks prior to treatment with the trial drug (in case of palliative radiotherapy such as for extremities, within the past 2 weeks prior to treatment with the trial drug)
- Previous therapy with other vascular endothelial growth factor receptor (VEGFR) inhibitors or vascular endothelial growth factor (VEGF) ligand inhibitors for treatment of NSCLC
- Previous therapy with BIBF 1120 and/or pemetrexed for treatment of NSCLC and any contraindications for therapy with pemetrexed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBF 1120 M + PemetrexedBIBF 1120 medium dose bid+ Pemetrexed 500 mg/m^2 | Drug | BIBF 1120 BID + Pemetrexed |
| BIBF 1120 H + PemetrexedBIBF 1120 high dose bid+ Pemetrexed 500 mg/m^2 | Drug | BIBF 1120 BID + Pemetrexed |
| BIBF 1120 RD + Pemetrexedconfirmed dose of BIBF 1120 bid + Pemetrexed 500 mg/m^2 | Drug | BIBF 1120 BID (RD) + Pemetrexed |
| BIBF 1120 L + PemetrexedBIBF 1120 low dose bid+ Pemetrexed 500 mg/m^2 | Drug | BIBF 1120 BID + Pemetrexed |
| BIBF 1120 Placebo + Pemetrexedplacebo BIBF 1120 bid + Pemetrexed 500 mg/m^2 | Drug | BIBF 1120 BID(Placebo) + Pemetrexed |
Primary outcome
Dose Limiting Toxicities
Time frame: During the first course, 21 days
Number of participants with dose limiting toxicity (DLT) in combination therapy of BIBF 1120 and pemetrexed during the first course
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses
Time frame: Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days
Number of patients with adverse events according to worst Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses. CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE) or 5 (death related to AE).
8 secondary outcomes
Overall Response Rate
Time frame: Every 6 weeks after start of study treatment until end of treatment, up to 992 days
Disease Control Rate
Time frame: Every 6 weeks after start of study treatment until end of treatment, up to 992 days
Duration of Disease Control
Time frame: From first study drug administration until PD or death, up to 1003 days
Number of Participants With Clinically Relevant Abnormalities in Laboratory Parameters
Time frame: Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days
AUC0-inf of Nintedanib
Time frame: 5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1
Cmax of Nintedanib
Time frame: 5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1
AUC0-inf of Pemetrexed
Time frame: 5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2
Cmax of Pemetrexed
Time frame: 5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26560486Daga H, Takeda K, Okada H, Miyazaki M, Ueda S, Kaneda H, Okamoto I, Yoh K, Goto K, Konishi K, Sarashina A, Tanaka T, Kaiser R, Nakagawa K. Phase I study of nintedanib in combination with pemetrexed as second-line treatment of Japanese patients with advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2015 Dec;76(6):1225-33. doi: 10.1007/s00280-015-2896-3. Epub 2015 Nov 11.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIBF 1120 M + Pemetrexed, BIBF 1120 H + Pemetrexed and BIBF 1120 RD + Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (time frame: During the first course, 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00979576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.