Metastatic Non-squamous Non Small Cell Lung CancerPhase 2CBP08-02NCT00942825
Triplet Combination First Line Treatment in Non Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing CBP501 + Cisplatin + Pemetrexed and Cisplatin + Pemetrexed in people with Metastatic Non-squamous Non Small Cell Lung Cancer, run by CanBas Co. Ltd. at 3 sites in United States.
Trial summary
This is a randomized, open-label, multicenter, phase II study to compare a triplet combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial effusion) or metastatic (stage IV) non-squamous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-squamous Non Small Cell Lung Cancer
- What is being tested?
- CBP501 + Cisplatin + Pemetrexed and Cisplatin + Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2009to Jul 2013
- 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
- Signed informed consent obtained prior to initiation of any study-specific procedures
- Histologically or cytologically confirmed diagnosis of non-squamous non small cell lung cancer (NSCLC), not amenable for radical resection, stage IIIB with pleural or pericardial effusion or stage IV, who has not received previous chemotherapy or other systemic treatment
- At least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- Male or female patients aged at least 18 years
- ECOG Performance Status (PS): 0-1
- Life expectancy > 3 months
Show all 16Show fewer
- Prior local radiotherapy is allowed if it was completed ≥ 3 weeks prior to the first dose of the study medication
- Concomitant palliative radiotherapy to an existing bone lesion for pain control is allowed
- Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study medication and patient should be fully recovered
- Adequate organ function, including the following:
- Bone marrow: white blood cell (WBC) count >= 4 x 109/L, absolute neutrophil count (ANC) >= 1.5 x 109/L, platelet count >= 100 x 109/L, hemoglobin >= 9 g/dL
- Hepatic: Bilirubin ≤ 1.5 x the upper limit of normal (ULN), aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if liver metastases are present), INR ≤ 1.5 x ULN, albumin >= 3.0 g/dL
- Renal: Serum creatinine ≤ 1.5 mg/dL or creatinine clearance >= 45 mL/min (calculated according to the Cockroft and Gault formula)
- Female patients of child-bearing potential must have a negative pregnancy test and be using at least one form of contraception as approved by the Investigator for 4 weeks prior to the study and 4 months after the last dose of study drug. For the purposes of this study, child-bearing potential is defined as: "All female patients unless they are post-menopausal for at least one year or are surgically sterile"
- Male patients must use a form of barrier contraception approved by the Investigator during the study and for 4 months after the last dose of study drug
- Ability to cooperate with the treatment and follow-up
Who cannot join
- Radiation therapy to more than 30% of the bone marrow prior to entry into the study
- Histology of pure bronchioloalveolar carcinoma or neuroendocrine features in the tumor sample
- Previous treatment with chemotherapy, new biological therapies (small molecules, antibodies), immunotherapy
- Absence of measurable lesions
- An ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the Investigator
- Any previous history of another malignancy within 5 years of study entry (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix)
Show all 18Show fewer
- Presence of any significant central nervous system (CNS) or psychiatric disorder(s) that would hamper the patient's compliance
- Evidence of peripheral neuropathy > grade 1 according to NCI-CTCAE Version 3
- Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry
- Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception
- Known HIV, HBV, HCV infection
- Presence of symptomatic brain metastasis. Patients with brain metastases must:
- Have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks after completion of the definitive therapy.
- Be without neurologic dysfunction that would confound the evaluation of neurologic and other AEs
- Inability or unwillingness to take folic acid, vitamin B12 or corticosteroids
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such piroxicam)
- Significant weight loss (>= 10% body weight during preceding 6 weeks)
- Presence of clinically significant (by physical exam) third space fluid collections, e.g., ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mary Crowley Cancer Research Centers
Dallas, Texas, 75246
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
Nevada Cancer Institute
Las Vegas, Nevada, 89135
About this study
Official title: Phase II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin as First Line Treatment in Patients With Stage IV Non-squamous Non Small Cell Lung Cancer (NSCLC)
This is a randomized, open-label, multicenter, phase II study to compare a triplet combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial effusion) or metastatic (stage IV) non-squamous NSCLC as consecutive i.v. infusions according to a once-every-3-weeks schedule.
The protocol will evaluate full-dose cisplatin and pemetrexed with or without CBP501. Patients will be randomized in a 1:1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or pemetrexed and cisplatin (Arm B). Randomization will be stratified according to whether or not patients are eligible for bevacizumab therapy.
Read more
Preclinical and clinical findings that support this protocol are:
- CBP501 has exhibited interesting preclinical activity in various lung cancer cell lines.
- Synergism was documented with CBP501/cisplatin in the preclinical studies with lung cancer cell lines.
- The dose-limiting toxicity (DLT) of CBP501 was rapid onset allergic reaction, as was suggested by preclinical toxicology. Other toxicities were quite limited. No evidence of potentiation of either CBP501 or cisplatin toxicity was found in the combination phase I trial, and the toxicity of the combination, primarily related to cisplatin, is manageable. It is expected that CBP501 and pemetrexed will display non-overlapping toxicity profiles in combination, given that hematological toxicity and gastrointestinal toxicity are the principal toxicity types of the latter.
- Given the acceptable safety of the cisplatin/ pemetrexed combination, it is anticipated that the addition of CBP501 to this combination can be evaluated without excessive risk in the phase II programs.
- The phase I study of CBP501 in combination with pemetrexed/cisplatin (phase I part of the mesothelioma program) did not show DLTs or evidence of enhancement of toxicities with the triplet combination. The RD of CBP501 25 mg/m², cisplatin 75 mg/m² and pemetrexed 500 mg/m² is currently in use in the phase II study with first line mesothelioma patients.
- Hints of activity were observed during the phase I study with CBP501 and cisplatin.
- No pharmacokinetics (PK) interaction was documented between cisplatin and CBP501.
Read the detailed description
This is a randomized, open-label, multicenter, phase II study to compare a triplet combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial effusion) or metastatic (stage IV) non-squamous NSCLC as consecutive i.v. infusions according to a once-every-3-weeks schedule.
The protocol will evaluate full-dose cisplatin and pemetrexed with or without CBP501. Patients will be randomized in a 1:1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or pemetrexed and cisplatin (Arm B). Randomization will be stratified according to whether or not patients are eligible for bevacizumab therapy.
The combination of cisplatin/pemetrexed has come to be recognized as the new standard of care for patients with untreated, unresectable malignant pleural mesothelioma (MPM) and untreated NSCLC non-squamous cell histology.
Preclinical and clinical findings that support this protocol are:
- CBP501 has exhibited interesting preclinical activity in various lung cancer cell lines.
- Synergism was documented with CBP501/cisplatin in the preclinical studies with lung cancer cell lines.
- The dose-limiting toxicity (DLT) of CBP501 was rapid onset allergic reaction, as was suggested by preclinical toxicology. Other toxicities were quite limited. No evidence of potentiation of either CBP501 or cisplatin toxicity was found in the combination phase I trial, and the toxicity of the combination, primarily related to cisplatin, is manageable. It is expected that CBP501 and pemetrexed will display non-overlapping toxicity profiles in combination, given that hematological toxicity and gastrointestinal toxicity are the principal toxicity types of the latter.
- Given the acceptable safety of the cisplatin/ pemetrexed combination, it is anticipated that the addition of CBP501 to this combination can be evaluated without excessive risk in the phase II programs.
- The phase I study of CBP501 in combination with pemetrexed/cisplatin (phase I part of the mesothelioma program) did not show DLTs or evidence of enhancement of toxicities with the triplet combination. The RD of CBP501 25 mg/m², cisplatin 75 mg/m² and pemetrexed 500 mg/m² is currently in use in the phase II study with first line mesothelioma patients.
- Hints of activity were observed during the phase I study with CBP501 and cisplatin.
- No pharmacokinetics (PK) interaction was documented between cisplatin and CBP501.
- Being tested
- CBP501 + Cisplatin + Pemetrexed, Cisplatin + Pemetrexed
- Keywords
- NSCL, non-squamous non small cell lung cancer, Lung Cancer, Lung, non-squamous, metastatic, pleural effusion, Stage IIIb, Stage IV, NSCLC
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP501 + Cisplatin + PemetrexedDrug
Also called CBP501 + CDDP + Alimta
CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
- CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.
- Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.
- Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
Cisplatin + PemetrexedDrug
Also called CDDP + Alimta
Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).
- Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.
- Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion.
| Study group | Role | What they receive |
|---|---|---|
| A CBP501 +Cisplatin + Pemetrexed | Experimental | CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2 Receives: Drug: CBP501 + Cisplatin + Pemetrexed |
| B Cisplatin + Pemetrexed | Active comparator | Cisplatin + Pemetrexed Receives: Drug: Cisplatin + Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Efficacy Endpoint is Progression Free Survival, Analyzed in the Treated Population. PFS is Assessed From Randomization Until Either Tumor Progression, as Per RECIST Criteria, or Until Death Due to Any Reason.
Measured: 15 June 2009 to 30 September 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2013
- Study completionJul 2013
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 (5)Papers the sponsor has linked to this study.
- Other trials for Metastatic Non-squamous 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanBas Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takumi Kawabe, MD, PhD, Study director, CanBas Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942825
- Sponsor's protocol ID
- CBP08-02
- Acronym
- CBP08-02
- Status last verified
- Mar 2017
- First submitted
- 17 Jul 2009
- Last updated
- 24 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shapiro GI, Tibes R, Gordon MS, Wong BY, Eder JP, Borad MJ, Mendelson DS, Vogelzang NJ, Bastos BR, Weiss GJ, Fernandez C, Sutherland W, Sato H, Pierceall WE, Weaver D, Slough S, Wasserman E, Kufe DW, Von Hoff D, Kawabe T, Sharma S. Phase I studies of CBP501, a G2 checkpoint abrogator, as monotherapy and in combination with cisplatin in patients with advanced solid tumors. Clin Cancer Res. 2011 May 15;17(10):3431-42. doi: 10.1158/1078-0432.CCR-10-2345. Epub 2011 Jan 10.
PubMed 21220472Mine N, Yamamoto S, Saito N, Yamazaki S, Suda C, Ishigaki M, Kufe DW, Von Hoff DD, Kawabe T. CBP501-calmodulin binding contributes to sensitizing tumor cells to cisplatin and bleomycin. Mol Cancer Ther. 2011 Oct;10(10):1929-38. doi: 10.1158/1535-7163.MCT-10-1139. Epub 2011 Aug 10.
PubMed 21831962Sha SK, Sato T, Kobayashi H, Ishigaki M, Yamamoto S, Sato H, Takada A, Nakajyo S, Mochizuki Y, Friedman JM, Cheng FC, Okura T, Kimura R, Kufe DW, Vonhoff DD, Kawabe T. Cell cycle phenotype-based optimization of G2-abrogating peptides yields CBP501 with a unique mechanism of action at the G2 checkpoint. Mol Cancer Ther. 2007 Jan;6(1):147-53. doi: 10.1158/1535-7163.MCT-06-0371.
PubMed 17237275Suganuma M, Kawabe T, Hori H, Funabiki T, Okamoto T. Sensitization of cancer cells to DNA damage-induced cell death by specific cell cycle G2 checkpoint abrogation. Cancer Res. 1999 Dec 1;59(23):5887-91.
PubMed 10606229Matsumoto Y, Shindo Y, Takakusagi Y, Takakusagi K, Tsukuda S, Kusayanagi T, Sato H, Kawabe T, Sugawara F, Sakaguchi K. Screening of a library of T7 phage-displayed peptides identifies alphaC helix in 14-3-3 protein as a CBP501-binding site. Bioorg Med Chem. 2011 Dec 1;19(23):7049-56. doi: 10.1016/j.bmc.2011.10.004. Epub 2011 Oct 7.
PubMed 22032894
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin as First Line Treatment in Patients With Stage IV Non-squamous Non Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00942825
- Acronym / sponsor ID
- CBP08-02 / CBP08-02
- Keywords
- NSCL, non-squamous non small cell lung cancer, Lung Cancer, Lung, non-squamous, metastatic, pleural effusion, Stage IIIb
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- CanBas Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Posted 24 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, multicenter, phase II study to compare a triplet combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial effusion) or metastatic (stage IV) non-squamous NSCLC as consecutive i.v. infusions according to a once-every-3-weeks schedule.
The protocol will evaluate full-dose cisplatin and pemetrexed with or without CBP501. Patients will be randomized in a 1:1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or pemetrexed and cisplatin (Arm B). Randomization will be stratified according to whether or not patients are eligible for bevacizumab therapy.
Preclinical and clinical findings that support this protocol are:
- CBP501 has exhibited interesting preclinical activity in various lung cancer cell lines.
- Synergism was documented with CBP501/cisplatin in the preclinical studies with lung cancer cell lines.
- The dose-limiting toxicity (DLT) of CBP501 was rapid onset allergic reaction, as was suggested by preclinical toxicology. Other toxicities were quite limited. No evidence of potentiation of either CBP501 or cisplatin toxicity was found in the combination phase I trial, and the toxicity of the combination, primarily related to cisplatin, is manageable. It is expected that CBP501 and pemetrexed will display non-overlapping toxicity profiles in combination, given that hematological toxicity and gastrointestinal toxicity are the principal toxicity types of the latter.
- Given the acceptable safety of the cisplatin/ pemetrexed combination, it is anticipated that the addition of CBP501 to this combination can be evaluated without excessive risk in the phase II programs.
- The phase I study of CBP501 in combination with pemetrexed/cisplatin (phase I part of the mesothelioma program) did not show DLTs or evidence of enhancement of toxicities with the triplet combination. The RD of CBP501 25 mg/m², cisplatin 75 mg/m² and pemetrexed 500 mg/m² is currently in use in the phase II study with first line mesothelioma patients.
- Hints of activity were observed during the phase I study with CBP501 and cisplatin.
- No pharmacokinetics (PK) interaction was documented between cisplatin and CBP501.
Detailed description
This is a randomized, open-label, multicenter, phase II study to compare a triplet combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial effusion) or metastatic (stage IV) non-squamous NSCLC as consecutive i.v. infusions according to a once-every-3-weeks schedule.
The protocol will evaluate full-dose cisplatin and pemetrexed with or without CBP501. Patients will be randomized in a 1:1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or pemetrexed and cisplatin (Arm B). Randomization will be stratified according to whether or not patients are eligible for bevacizumab therapy.
The combination of cisplatin/pemetrexed has come to be recognized as the new standard of care for patients with untreated, unresectable malignant pleural mesothelioma (MPM) and untreated NSCLC non-squamous cell histology.
Preclinical and clinical findings that support this protocol are:
- CBP501 has exhibited interesting preclinical activity in various lung cancer cell lines.
- Synergism was documented with CBP501/cisplatin in the preclinical studies with lung cancer cell lines.
- The dose-limiting toxicity (DLT) of CBP501 was rapid onset allergic reaction, as was suggested by preclinical toxicology. Other toxicities were quite limited. No evidence of potentiation of either CBP501 or cisplatin toxicity was found in the combination phase I trial, and the toxicity of the combination, primarily related to cisplatin, is manageable. It is expected that CBP501 and pemetrexed will display non-overlapping toxicity profiles in combination, given that hematological toxicity and gastrointestinal toxicity are the principal toxicity types of the latter.
- Given the acceptable safety of the cisplatin/ pemetrexed combination, it is anticipated that the addition of CBP501 to this combination can be evaluated without excessive risk in the phase II programs.
- The phase I study of CBP501 in combination with pemetrexed/cisplatin (phase I part of the mesothelioma program) did not show DLTs or evidence of enhancement of toxicities with the triplet combination. The RD of CBP501 25 mg/m², cisplatin 75 mg/m² and pemetrexed 500 mg/m² is currently in use in the phase II study with first line mesothelioma patients.
- Hints of activity were observed during the phase I study with CBP501 and cisplatin.
- No pharmacokinetics (PK) interaction was documented between cisplatin and CBP501.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A CBP501 +Cisplatin + Pemetrexed | Experimental | Drug: CBP501 + Cisplatin + PemetrexedCBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2 |
| B Cisplatin + Pemetrexed | Active comparator | Drug: Cisplatin + PemetrexedCisplatin + Pemetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent obtained prior to initiation of any study-specific procedures
- Histologically or cytologically confirmed diagnosis of non-squamous non small cell lung cancer (NSCLC), not amenable for radical resection, stage IIIB with pleural or pericardial effusion or stage IV, who has not received previous chemotherapy or other systemic treatment
- At least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- Male or female patients aged at least 18 years
- ECOG Performance Status (PS): 0-1
Key exclusion criteria (18 listed)
- Radiation therapy to more than 30% of the bone marrow prior to entry into the study
- Histology of pure bronchioloalveolar carcinoma or neuroendocrine features in the tumor sample
- Previous treatment with chemotherapy, new biological therapies (small molecules, antibodies), immunotherapy
- Absence of measurable lesions
- An ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the Investigator
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 |
|---|---|---|
| CBP501 + Cisplatin + PemetrexedAlso: CBP501 + CDDP + AlimtaCBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days). 1. CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour. 2. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion. 3. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion. | Drug | A CBP501 +Cisplatin + Pemetrexed |
| Cisplatin + PemetrexedAlso: CDDP + AlimtaPemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days). 1. Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes. 2. Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion. | Drug | B Cisplatin + Pemetrexed |
Primary outcome
The Primary Efficacy Endpoint is Progression Free Survival, Analyzed in the Treated Population. PFS is Assessed From Randomization Until Either Tumor Progression, as Per RECIST Criteria, or Until Death Due to Any Reason.
Time frame: 15 June 2009 to 30 September 2012
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21220472Shapiro GI, Tibes R, Gordon MS, Wong BY, Eder JP, Borad MJ, Mendelson DS, Vogelzang NJ, Bastos BR, Weiss GJ, Fernandez C, Sutherland W, Sato H, Pierceall WE, Weaver D, Slough S, Wasserman E, Kufe DW, Von Hoff D, Kawabe T, Sharma S. Phase I studies of CBP501, a G2 checkpoint abrogator, as monotherapy and in combination with cisplatin in patients with advanced solid tumors. Clin Cancer Res. 2011 May 15;17(10):3431-42. doi: 10.1158/1078-0432.CCR-10-2345. Epub 2011 Jan 10.
- Background: PubMed 21831962Mine N, Yamamoto S, Saito N, Yamazaki S, Suda C, Ishigaki M, Kufe DW, Von Hoff DD, Kawabe T. CBP501-calmodulin binding contributes to sensitizing tumor cells to cisplatin and bleomycin. Mol Cancer Ther. 2011 Oct;10(10):1929-38. doi: 10.1158/1535-7163.MCT-10-1139. Epub 2011 Aug 10.
- Background: PubMed 17237275Sha SK, Sato T, Kobayashi H, Ishigaki M, Yamamoto S, Sato H, Takada A, Nakajyo S, Mochizuki Y, Friedman JM, Cheng FC, Okura T, Kimura R, Kufe DW, Vonhoff DD, Kawabe T. Cell cycle phenotype-based optimization of G2-abrogating peptides yields CBP501 with a unique mechanism of action at the G2 checkpoint. Mol Cancer Ther. 2007 Jan;6(1):147-53. doi: 10.1158/1535-7163.MCT-06-0371.
- Background: PubMed 10606229Suganuma M, Kawabe T, Hori H, Funabiki T, Okamoto T. Sensitization of cancer cells to DNA damage-induced cell death by specific cell cycle G2 checkpoint abrogation. Cancer Res. 1999 Dec 1;59(23):5887-91.
- Background: PubMed 22032894Matsumoto Y, Shindo Y, Takakusagi Y, Takakusagi K, Tsukuda S, Kusayanagi T, Sato H, Kawabe T, Sugawara F, Sakaguchi K. Screening of a library of T7 phage-displayed peptides identifies alphaC helix in 14-3-3 protein as a CBP501-binding site. Bioorg Med Chem. 2011 Dec 1;19(23):7049-56. doi: 10.1016/j.bmc.2011.10.004. Epub 2011 Oct 7.
- Individual participant dataSharing planned: No
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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.
Takumi Kawabe, MD, PhD study director
CanBas Co. Ltd.
3 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 CBP501 + Cisplatin + Pemetrexed and Cisplatin + Pemetrexed in people with Metastatic Non-squamous Non Small Cell Lung Cancer, run by CanBas Co. Ltd. at 3 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 16 inclusion and 18 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 24 May 2017. 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 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 24 May 2017). 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?
The Primary Efficacy Endpoint is Progression Free Survival, Analyzed in the Treated Population. PFS is Assessed From Randomization Until Either Tumor Progression, as Per RECIST Criteria, or Until Death Due to Any Reason. (time frame: 15 June 2009 to 30 September 2012). 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 NCT00942825, which also lists 5 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 24 May 2017.