TumorsPhase 2FALCONNCT00653939
A Safety and Efficacy Study of Carboplatin, Paclitaxel, Bevacizumab and CA4P in Non-Small Cell Lung Cancer
A Phase 2 study testing Fosbretabulin, Carboplatin and Paclitaxel in people with Tumors, run by Mateon Therapeutics at 15 sites in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability and efficacy of combretastatin A4 phosphate (CA4P), also known as fosbretabulin, in combination with bevacizumab (Avastin), carboplatin and paclitaxel in patients with chemotherapy naïve non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- Fosbretabulin, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2008to Oct 2011
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed Stage IIIB NSCLC with malignant pleural effusion, or Stage IV disease
- Measurable disease on CT scan (by the Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 (which means able to independently care for self and to perform light work) .
- Adequate blood counts
- Adequate liver and kidney function
- Subjects or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial.
Who cannot join
- Predominant Squamous Cell NSCLC histology.
- History of treatment for NSCLC with chemotherapy, biological therapy, immunotherapy (surgery or radiation therapy are accepted)
- Brain (CNS) metastasis by head CT scan or MRI
- Subjects with history of prior malignancy except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasia; or localized prostate cancer with a current prostate specific antigen (PSA) of < 4.0 mg/dL. Subjects with other curatively treated malignancies who have no evidence of metastatic disease and >2 year disease free interval may be entered after discussion with the Medical Monitor.
- History of bleeding disorders, particularly coughing up ≥ ½ teaspoon bright red blood during the last 3 months
- Certain cardiac disorders such as recent myocardial infarction (MI), severe congestive heart failure, certain types of abnormal cardiac rhythm
Show all 11Show fewer
- Uncontrolled high blood pressure despite medications
- Uncontrolled, clinically significant active infection.
- Known HIV
- Known hypersensitivity to any of the components of CA4P, paclitaxel, carboplatin, bevacizumab, or radiologic contrast dyes.
- Details of the above and additional inclusion and exclusion criteria can be discussed with an investigator.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, 21020
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
Southbay Oncology Hematology
Campbell, California, 95008
Gabrail Cancer Center
Canton, Ohio, 44718
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003
The Mark H. Zangmeister Center
Columbus, Ohio, 43219
San Juan Oncology Associates
Farmington, New Mexico, 87401
Pacific Coast Hematology and Oncology Medical Group
Fountain Valley, California, 92708
UCLA Division of Hematology and Oncology
Los Angeles, California, 90095
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202
Signal Point Clinical Research
Middletown, Ohio, 45042
Mary Babb Randolph Cancer Center-Clinical Trials Unit
Morgantown, West Virginia, 26506
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, 94523
Blueridge Cancer Care
Salem, Virginia, 24153
Northwest Medical Specialties
Tacoma, Washington, 98405
About this study
Official title: A Phase II Study to Assess the Safety and Efficacy of the Combination of Carboplatin, Paclitaxel, and Bevacizumab ± Combretastatin A4 Phosphate (CA4P) Followed by Bevacizumab ± CA4P in Subjects With Chemotherapy Naïve Stage IIIB/IV Non-Squamous Cell Histology Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to determine the safety, tolerability and efficacy of combretastatin A4 phosphate (CA4P), also known as fosbretabulin, in combination with bevacizumab (Avastin), carboplatin and paclitaxel in patients with chemotherapy naïve non-small cell lung cancer (NSCLC). This is a randomized parallel arm study. All participants will receive carboplatin, paclitaxel and bevacizumab, and half will additionally receive CA4P. Patients who complete the first 6 cycles of therapy and have not experienced disease progression will receive maintenance therapy with bevacizumab alone or with bevacizumab plus CA4P.
The rationale for this study is the potential additive or synergistic actions of vascular disrupting agents like CA4P with anti-angiogenic agents like bevacizumab.
Read the detailed description
Lung cancer has become the leading cause of cancer death in both men and women in the US and Europe, accounting for 29% of all cancer deaths. Non-Small Cell Lung cancer (NSCLC) accounts for approximately 80% of all lung cancer cases. Currently, no curative treatment is available for advanced stages of the disease (stages III and IV), which comprise the majority of cases. Treatment with the combination of carboplatin and paclitaxel has been shown to be effective and well tolerated in advanced stage NSCLC. Targeted therapies, such as bevacizumab, often act synergistically with chemotherapy. Bevacizumab inhibits vascular endothelial growth factor (VEGF), necessary for endothelial cell proliferation and new blood vessel formation. CA4P targets existing abnormal vasculature of tumors, impeding tumor blood flow and leading to extensive tumor cell death as a consequence of oxygen and nutrient deprivation.
This study will compare the effect of CA4P when combined with chemotherapy and bevacizumab on progression free survival (PFS) to PFS after chemotherapy and bevacizumab alone.
- Conditions
- Tumors
- Being tested
- Fosbretabulin, Carboplatin, Paclitaxel, Bevacizumab
- Keywords
- non-small cell lung cancer, non-small cell lung carcinoma, neoplasms, lung, lung cancer, tumors, NSCLC
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosbretabulinDrug
Also called Combretastatin A4 Phosphate, Zybrestat, CA4P
Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.
CarboplatinDrug
Also called Paraplatin
Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.
PaclitaxelDrug
Also called Taxol
Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.
BevacizumabDrug
Also called Avastin
Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Chemotherapy+Bevacizumab | Active comparator | Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization. Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab |
| Arm 2: Active Comparator+Fosbretabulin | Experimental | Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization. Receives: Drug: Fosbretabulin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) in the Intent-to-Treat Population
Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started.
Measured: Six 21-day cycles
Secondary outcomes (5)
Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population
Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 for target lesions (assessed by MRI or CT scan): Complete Response (CR) is defined as the disappearance of all target lesions, Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, Progressive Disease is defined as at least 20% increase in the sum of the longest diameter of target lesions, Stable Disease (SD) is defined as neither shrinkage to qualify for a PR or increase to qualify for a PD.
Measured: Six 21-day cycles
Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population
Measured: Until death or lost to follow-up, up to 12 months since randomization
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Measured: Days 1 (pretreatment) per 21-day Cycle (6 Cycles)
Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)
Measured: Days 1 (pretreatment), 7, 14, and 21 per 21-day Cycle (6 Cycles)
Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)
Measured: Day 1 (pretreatment) per 21-day Cycle (6 Cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2011
- Study completionOct 2011
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 (7)Papers the sponsor has linked to this study.
- Other trials for TumorsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mateon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jai Balkissoon, MD, FACS, Study director, Mateon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653939
- Sponsor's protocol ID
- OXC401-216
- Acronym
- FALCON
- Status last verified
- Jan 2015
- First submitted
- 18 Mar 2008
- Last updated
- 9 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lin CM, Singh SB, Chu PS, Dempcy RO, Schmidt JM, Pettit GR, Hamel E. Interactions of tubulin with potent natural and synthetic analogs of the antimitotic agent combretastatin: a structure-activity study. Mol Pharmacol. 1988 Aug;34(2):200-8.
PubMed 3412321Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.
PubMed 17167137Monestiroli S, Mancuso P, Burlini A, Pruneri G, Dell'Agnola C, Gobbi A, Martinelli G, Bertolini F. Kinetics and viability of circulating endothelial cells as surrogate angiogenesis marker in an animal model of human lymphoma. Cancer Res. 2001 Jun 1;61(11):4341-4.
PubMed 11389057Ferrara N, Davis-Smyth T. The biology of vascular endothelial growth factor. Endocr Rev. 1997 Feb;18(1):4-25. doi: 10.1210/edrv.18.1.0287. No abstract available.
PubMed 9034784Chaplin DJ, Pettit GR, Hill SA. Anti-vascular approaches to solid tumour therapy: evaluation of combretastatin A4 phosphate. Anticancer Res. 1999 Jan-Feb;19(1A):189-95.
PubMed 10226542Siemann DW, Mercer E, Lepler S, Rojiani AM. Vascular targeting agents enhance chemotherapeutic agent activities in solid tumor therapy. Int J Cancer. 2002 May 1;99(1):1-6. doi: 10.1002/ijc.10316.
PubMed 11948484Shaked Y, Ciarrocchi A, Franco M, Lee CR, Man S, Cheung AM, Hicklin DJ, Chaplin D, Foster FS, Benezra R, Kerbel RS. Therapy-induced acute recruitment of circulating endothelial progenitor cells to tumors. Science. 2006 Sep 22;313(5794):1785-7. doi: 10.1126/science.1127592.
PubMed 16990548
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Assess the Safety and Efficacy of the Combination of Carboplatin, Paclitaxel, and Bevacizumab ± Combretastatin A4 Phosphate (CA4P) Followed by Bevacizumab ± CA4P in Subjects With Chemotherapy Naïve Stage IIIB/IV Non-Squamous Cell Histology Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00653939
- Acronym / sponsor ID
- FALCON / OXC401-216
- Conditions
- Tumors
- Keywords
- non-small cell lung cancer, non-small cell lung carcinoma, neoplasms, lung, lung cancer, tumors, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Mateon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Posted 9 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, tolerability and efficacy of combretastatin A4 phosphate (CA4P), also known as fosbretabulin, in combination with bevacizumab (Avastin), carboplatin and paclitaxel in patients with chemotherapy naïve non-small cell lung cancer (NSCLC). This is a randomized parallel arm study. All participants will receive carboplatin, paclitaxel and bevacizumab, and half will additionally receive CA4P. Patients who complete the first 6 cycles of therapy and have not experienced disease progression will receive maintenance therapy with bevacizumab alone or with bevacizumab plus CA4P.
The rationale for this study is the potential additive or synergistic actions of vascular disrupting agents like CA4P with anti-angiogenic agents like bevacizumab.
Detailed description
Lung cancer has become the leading cause of cancer death in both men and women in the US and Europe, accounting for 29% of all cancer deaths. Non-Small Cell Lung cancer (NSCLC) accounts for approximately 80% of all lung cancer cases. Currently, no curative treatment is available for advanced stages of the disease (stages III and IV), which comprise the majority of cases. Treatment with the combination of carboplatin and paclitaxel has been shown to be effective and well tolerated in advanced stage NSCLC. Targeted therapies, such as bevacizumab, often act synergistically with chemotherapy. Bevacizumab inhibits vascular endothelial growth factor (VEGF), necessary for endothelial cell proliferation and new blood vessel formation. CA4P targets existing abnormal vasculature of tumors, impeding tumor blood flow and leading to extensive tumor cell death as a consequence of oxygen and nutrient deprivation.
This study will compare the effect of CA4P when combined with chemotherapy and bevacizumab on progression free survival (PFS) to PFS after chemotherapy and bevacizumab alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Chemotherapy+Bevacizumab | Active comparator | Drug: Carboplatin, Drug: Paclitaxel, Drug: BevacizumabCarboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization. |
| Arm 2: Active Comparator+Fosbretabulin | Experimental | Drug: Fosbretabulin, Drug: Carboplatin, Drug: Paclitaxel, Drug: BevacizumabCarboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed Stage IIIB NSCLC with malignant pleural effusion, or Stage IV disease
- Measurable disease on CT scan (by the Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 (which means able to independently care for self and to perform light work) .
- Adequate blood counts
- Adequate liver and kidney function
Key exclusion criteria (11 listed)
- Predominant Squamous Cell NSCLC histology.
- History of treatment for NSCLC with chemotherapy, biological therapy, immunotherapy (surgery or radiation therapy are accepted)
- Brain (CNS) metastasis by head CT scan or MRI
- Subjects with history of prior malignancy except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasia; or localized prostate cancer with a current prostate specific antigen (PSA) of < 4.0 mg/dL. Subjects with other curatively treated malignancies who have no evidence of metastatic disease and >2 year disease free interval may be entered after discussion with the Medical Monitor.
- History of bleeding disorders, particularly coughing up ≥ ½ teaspoon bright red blood during the last 3 months
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 |
|---|---|---|
| FosbretabulinAlso: Combretastatin A4 Phosphate, Zybrestat, CA4PArm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles. | Drug | Arm 2: Active Comparator+Fosbretabulin |
| CarboplatinAlso: ParaplatinChemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles. | Drug | Arm 1: Chemotherapy+Bevacizumab, Arm 2: Active Comparator+Fosbretabulin |
| PaclitaxelAlso: TaxolChemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles. | Drug | Arm 1: Chemotherapy+Bevacizumab, Arm 2: Active Comparator+Fosbretabulin |
| BevacizumabAlso: AvastinBevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles. | Drug | Arm 1: Chemotherapy+Bevacizumab, Arm 2: Active Comparator+Fosbretabulin |
Primary outcome
Progression Free Survival (PFS) in the Intent-to-Treat Population
Time frame: Six 21-day cycles
Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started.
5 secondary outcomes
Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population
Time frame: Six 21-day cycles
Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population
Time frame: Until death or lost to follow-up, up to 12 months since randomization
Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)
Time frame: Days 1 (pretreatment) per 21-day Cycle (6 Cycles)
Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)
Time frame: Days 1 (pretreatment), 7, 14, and 21 per 21-day Cycle (6 Cycles)
Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)
Time frame: Day 1 (pretreatment) per 21-day Cycle (6 Cycles)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3412321Lin CM, Singh SB, Chu PS, Dempcy RO, Schmidt JM, Pettit GR, Hamel E. Interactions of tubulin with potent natural and synthetic analogs of the antimitotic agent combretastatin: a structure-activity study. Mol Pharmacol. 1988 Aug;34(2):200-8.
- Background: PubMed 17167137Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.
- Background: PubMed 11389057Monestiroli S, Mancuso P, Burlini A, Pruneri G, Dell'Agnola C, Gobbi A, Martinelli G, Bertolini F. Kinetics and viability of circulating endothelial cells as surrogate angiogenesis marker in an animal model of human lymphoma. Cancer Res. 2001 Jun 1;61(11):4341-4.
- Background: PubMed 9034784Ferrara N, Davis-Smyth T. The biology of vascular endothelial growth factor. Endocr Rev. 1997 Feb;18(1):4-25. doi: 10.1210/edrv.18.1.0287. No abstract available.
- Background: PubMed 10226542Chaplin DJ, Pettit GR, Hill SA. Anti-vascular approaches to solid tumour therapy: evaluation of combretastatin A4 phosphate. Anticancer Res. 1999 Jan-Feb;19(1A):189-95.
- Background: PubMed 11948484Siemann DW, Mercer E, Lepler S, Rojiani AM. Vascular targeting agents enhance chemotherapeutic agent activities in solid tumor therapy. Int J Cancer. 2002 May 1;99(1):1-6. doi: 10.1002/ijc.10316.
- Background: PubMed 16990548Shaked Y, Ciarrocchi A, Franco M, Lee CR, Man S, Cheung AM, Hicklin DJ, Chaplin D, Foster FS, Benezra R, Kerbel RS. Therapy-induced acute recruitment of circulating endothelial progenitor cells to tumors. Science. 2006 Sep 22;313(5794):1785-7. doi: 10.1126/science.1127592.
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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.
Jai Balkissoon, MD, FACS study director
Mateon Therapeutics
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fosbretabulin, Carboplatin and Paclitaxel in people with Tumors, run by Mateon Therapeutics at 15 sites in United States.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 9 Feb 2015). 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?
Progression Free Survival (PFS) in the Intent-to-Treat Population (time frame: Six 21-day cycles). 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 NCT00653939, which also lists 7 linked publications.
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 9 Feb 2015.