Non-Small Cell Lung CancerPhase 3NCT00437749
A Study of CBT-1 and Paclitaxel With Carboplatin in Patients With Advanced Inoperable Non-small Cell Lung Cancer
A Phase 3 study testing CBT-1 in people with Non-Small Cell Lung Cancer, run by CBA Research at 1 site in United States.
Trial summary
Multiple Drug Resistance is the phenomena whereby cells become resistant to a variety of drugs with different mechanisms of action. Drug resistance remains a significant impediment to successful cancer chemotherapy inhibitors have been developed and are currently in clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- CBT-1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Nov 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- histological confirmed diagnosis of NSCLC
- advanced inoperable NSCLC
- have adequate renal function, serum creatinine <2.0 mg/dL or 24 hour creatinine clearance > 50mL/minute
- have adequate liver function defined as SGOT <4 times the upper limit of normal (ULN) and bilirubin <2.0 mg/dL
- have calcium <11.0 mg/dL and albumin >2.0g/dL
- have adequate bone marrow reserve defined as granulocyte count >1,500/mm3, hemoglobin >10.0 g/dL and platelets >100,000/mm3
- if female and of child-bearing potential, agree to use one of the following methods of birth control: oral contraceptives, barrier with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse
Who cannot join
- have previously received taxanes, platinums, vinca alkaloids, anthracyclines, epipodophyllotoxins or CBT-1
- have known or suspected hypersensitivity to platinum containing compounds, taxanes, polyoxyethylated castor oil, or mannitol
- have significant central nervous system disease, including history of seizures within last 3 months or psychiatric history which would impair the ability to give informed consent or prevent compliance with protocol requirements
- be eligible for curative surgery or radiotherapy.
- must not have a diagnosis and/or treatment in the past 5 years of any malignancy other than NSCLC or basal cell carcinoma of the skin
- be pregnant or nursing
Show all 14Show fewer
- have a history of significant coronary artery disease, cardiac arrhythmias requiring treatment, history of other cardiac disease or other cardiac anomalies determined by ECG which in the judgment of the investigator would compromise the patient's ability to tolerate the therapy
- have ongoing serious infections that require parenteral antibiotics
- have clinically significant bleeding disorders
- have solid organ allograft
- have significant intercurrent disease
- have bleeding peptic ulcer disease
- have participated in any experimental study within 2 months preceding enrollment
- be using a medication that could interact adversely with CBT-1, paclitaxel, or carboplatin. Medications include:aminoglycoside antibiotics, Prilosec, Losec, Zantac
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Clinical Research Center
Tuscon, Arizona, 85715
About this study
Official title: Phase 3, Randomized, Double-Blind, Placebo-controlled Study of CBT-1 and Paclitaxel/Carboplatin in Patients With Inoperable Non-Small Cell Lung Cancer
Multiple Drug Resistance is the phenomena whereby cells become resistant to a variety of drugs with different mechanisms of action. Drug resistance remains a significant impediment to successful cancer chemotherapy inhibitors have been developed and are currently in clinical trials. CBT-1 is a natural product currently in clinical trials as an inhibitor
Read the detailed description
Lung cancer has the highest incidence and prevalence among cancers in the world and remains the leading cause of cancer-related deaths in Western countries. One-year survival of patients with best supportive care remains low. Non-small-cell lung cancer accounts for almost 85% of all lung cancer cases. Approximately 70% of patients have locally advanced or metastatic disease at presentation and are not candidates for surgery.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- CBT-1, Placebo
- Keywords
- Non small cell lung cancer, Advanced, Inoperable, taxanes, carboplatin, multi-drug resistance
- 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.
CBT-1Drug
(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6
PlaceboOther
(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6
| Study group | Role | What they receive |
|---|---|---|
| CBT-1 | Active comparator | Not described Receives: Drug: CBT-1 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: every month for first 6 months off study, then every 2-3 months for the next year, then every 6 months thereafter
Secondary outcomes (3)
Time to Progression
Measured: each month for the first 6 months off study, then every 2-3 months for the next year, then every 6 months thereafter.
Response Rates
Measured: every 2-3 months following completion of therapy until disease progression
Progression Free Survival
Measured: every month for first 6 months off study, then every 2-3 months for next year, then every 6 months thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startAug 2001
- Primary completionJul 2010
- Study completionNov 2010
Why it stopped: slow accrual rate; interim accrual objective met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- CBA Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Oldham, MD, Principal investigator, CBA Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437749
- Sponsor's protocol ID
- CBA-TP0301
- Status last verified
- Sep 2011
- First submitted
- 19 Feb 2007
- Last updated
- 9 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Double-Blind, Placebo-controlled Study of CBT-1 and Paclitaxel/Carboplatin in Patients With Inoperable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00437749
- Acronym / sponsor ID
- CBA-TP0301
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non small cell lung cancer, Advanced, Inoperable, taxanes, carboplatin, multi-drug resistance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual rate; interim accrual objective met
- Enrolment
- 214 participants (actual)
- Lead sponsor
- CBA ResearchIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 21 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple Drug Resistance is the phenomena whereby cells become resistant to a variety of drugs with different mechanisms of action. Drug resistance remains a significant impediment to successful cancer chemotherapy inhibitors have been developed and are currently in clinical trials. CBT-1 is a natural product currently in clinical trials as an inhibitor
Detailed description
Lung cancer has the highest incidence and prevalence among cancers in the world and remains the leading cause of cancer-related deaths in Western countries. One-year survival of patients with best supportive care remains low. Non-small-cell lung cancer accounts for almost 85% of all lung cancer cases. Approximately 70% of patients have locally advanced or metastatic disease at presentation and are not candidates for surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-1 | Active comparator | Drug: CBT-1 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- histological confirmed diagnosis of NSCLC
- advanced inoperable NSCLC
- have adequate renal function, serum creatinine <2.0 mg/dL or 24 hour creatinine clearance > 50mL/minute
- have adequate liver function defined as SGOT <4 times the upper limit of normal (ULN) and bilirubin <2.0 mg/dL
- have calcium <11.0 mg/dL and albumin >2.0g/dL
Key exclusion criteria (14 listed)
- have previously received taxanes, platinums, vinca alkaloids, anthracyclines, epipodophyllotoxins or CBT-1
- have known or suspected hypersensitivity to platinum containing compounds, taxanes, polyoxyethylated castor oil, or mannitol
- have significant central nervous system disease, including history of seizures within last 3 months or psychiatric history which would impair the ability to give informed consent or prevent compliance with protocol requirements
- be eligible for curative surgery or radiotherapy.
- must not have a diagnosis and/or treatment in the past 5 years of any malignancy other than NSCLC or basal cell carcinoma of the skin
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 |
|---|---|---|
| CBT-1(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6 | Drug | CBT-1 |
| Placebo(50 mg caps) 500 mg/m2/day x 7 + paclitaxel 135 mg/m2 + carboplatin AUC 6 | Other | Placebo |
Primary outcome
Overall Survival
Time frame: every month for first 6 months off study, then every 2-3 months for the next year, then every 6 months thereafter
3 secondary outcomes
Time to Progression
Time frame: each month for the first 6 months off study, then every 2-3 months for the next year, then every 6 months thereafter.
Response Rates
Time frame: every 2-3 months following completion of therapy until disease progression
Progression Free Survival
Time frame: every month for first 6 months off study, then every 2-3 months for next year, then every 6 months thereafter.
Results and safety
The study was stopped early (reason given: slow accrual rate; interim accrual objective met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Robert Oldham, MD principal investigator
CBA Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CBT-1 in people with Non-Small Cell Lung Cancer, run by CBA Research at 1 site 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 7 inclusion and 14 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 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow accrual rate; interim accrual objective met). Results are not available in the source record.
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?
Overall Survival (time frame: every month for first 6 months off study, then every 2-3 months for the next year, then every 6 months thereafter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2011.