Non Small Cell Lung CancerPhase 1/2NCT00735878
Pharmacokinetic & Pharmacodynamic Study of ABT-751 With Carboplatin in Patients With Advanced Lung Cancer
A Phase 1/2 study testing ABT-751 and Carboplatin in people with Non Small Cell Lung Cancer and Lung Cancer, run by Konstantin Dragnev at 1 site in United States.
Trial summary
Primary Objectives: The primary objectives of this study are as follows: To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of escalating ABT-751 in combination with fixed dose carboplatin in patients with advanced 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
- Non Small Cell Lung Cancer, Lung Cancer
- What is being tested?
- ABT-751 and Carboplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jan 2009
- Phase
- Phase 1/2
- 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
- At least 18 years of age.
- Pathologically or cytologically confirmed diagnosis of NSCLC .
- At least one measurable lesion (not amenable to resection) for Response Evaluation Criteria in Solid Tumors (RECIST) tumor assessments. Target lesions must not have been in the previous radiation port.
- Advanced stage of disease (IIIB with malignant pleural effusion or Stage IV) with no known curative treatment that has progressed despite therapy for recurrent/metastatic disease or prior therapy was discontinued due to intolerable toxicities. During the phase II portion of the study, previously untreated patients with IIIB with malignant pleural effusion or Stage IV NSCLC may be enrolled.
- For patients participating in the phase I part of the study, no alternative therapy is available that is expected to prolong overall or progression-free survival. Unacceptable toxicities during first- or second-line therapy or evidence for disease progression.
- Adequate hematologic, renal and hepatic function as follows:
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- Hematologic: ANC (absolute neutrophil count) ≥ 1200/mm3; Platelets; ≥ 100,000/mm3; hemoglobin: ≥ 8.5 g/dL;
- Renal function: serum creatinine ≤ 2.0 mg/dL; renal (CrCl > 50 ml/min by Jelliffe or Cockcroft Gault Formula),
- Hepatic function: Bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with liver metastases); AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 2.5 X the upper limits of normal (ULN) (≤ 5 X ULN for patients with liver metastases).
- Adequate performance status, Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
- Prior platinum (cisplatin, carboplatin or oxaliplatin) therapy is allowed.
- Patient or patient's legally acceptable representative has voluntarily signed and dated an informed consent form approved by an Institutional Review Board (IRB), prior to any study-specific procedures.
Who cannot join
- Any other malignancy within 3 years except in situ carcinoma.
- Untreated central nervous system (CNS) metastasis.
- A greater than Grade 1 National Cancer Institute Common Toxicity Criteria (NCI CTC) neurology category findings at baseline.
- Concurrent anti-cancer therapy or radiotherapy.
- Concurrent therapy with colchicines.
- Prior therapy with ABT-751.
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- Cytotoxic chemotherapy within 3 weeks of initiating investigational treatment.
- Any investigational therapy within 4 weeks.
- Female patients that are pregnant or breastfeeding.
- Patients of childbearing potential (male and female) that do not agree to use a contraceptive method deemed acceptable by the investigator while in the study and for up to three months following completion of therapy.
- Documented allergy or hypersensitivity to carboplatin or sulfa.
- Patient has received more than 2 prior chemotherapy regimens for advanced disease. Adjuvant chemotherapy administered more than 6 months prior to enrollment does not count towards this limit.
- Patient is classified as 3 or 4 by New York Heart Association (NYHA) Functional Classification, defined as:
- Class 3: Patients with marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes symptoms.
- Class 4: Patients are unable to carry on any physical activity without symptoms and symptoms are present even at rest.
- Evidence of clinically significant medical condition(s) that compromises safety, compliance, or study conduct, and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Phase I/II Pharmacokinetic and Pharmacodynamic Study of ABT-751 in Combination With Carboplatin in Patients With Advanced Lung Cancer
Primary Objectives:
The primary objectives of this study are as follows:
Read more
- To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of escalating ABT-751 in combination with fixed dose carboplatin in patients with advanced non small cell lung cancer (NSCLC).
- To evaluate the efficacy of the combination with ABT-751 and carboplatin in patients with advanced NSCLC
- To determine the median survival in the study population
Secondary Objectives
The secondary objectives are:
- To characterize the pharmacokinetic profile of ABT-751 given in combination with carboplatin in a subset of patients, treated at the MTD or recommended doses for Phase 2.
- To determine the pharmacodynamics of ABT-751 as a single agent and the combination of ABT-751 and carboplatin as evaluated by cell cycle analysis of buccal mucosa cells.
Read the detailed description
This primary objective of this Phase 1/2 study is to evaluate the DLT and MTD of escalating oral doses of ABT-751 given BID (twice daily) on Day 1 of each cycle for 7 days in combination with carboplatin given on a 21-day schedule. The carboplatin dose is fixed at AUC 6 and will be administered on Day 4 during the first cycle to facilitate the pharmacokinetic analysis. During the subsequent cycles both agents will be administered on Day 1. ABT-751 is administered at the following dose levels using the Simon rapid dose escalation model: 100, mg, 125 mg, 150 mg, 175 mg and 200 mg BID.
Initially, 1 patient will be enrolled in dose level 1. If the patient experiences a Grade 2 toxicity, an additional 2 patients will be enrolled at the same dose level. If 1 of the 3 patients experiences a Grade 3 (or higher toxicity), the cohort will be expanded to 6 patients. However, if 1 patient completes one cycle at the assigned dose regimen without experiencing a Grade 2 toxicity, enrollment in the next cohort (dose level 2) can begin. This rapid dose escalation scheme will apply to cohorts 1 through 3.
Initially, in the 4th cohort (dose level 4), a minimum of three patients will be enrolled. If 1 of the 3 patients experiences a Grade 3 (or higher toxicity), the cohort will be expanded to 6 patients. However, if 3 patients complete one cycle at the assigned dose regimen without experiencing a Grade 3 (or higher toxicity), enrollment in the next cohort (dose level 5) can begin. This scheme will apply to cohorts 4, 5, and 6 MTD is defined as the highest dose of ABT-751 given in combination with carboplatin at which fewer than 33% of patients experience DLT. MTD will be evaluated at the end of the first cycle (21 days). Toxicities will be determined also at the end of cycle 2 to evaluate the safety of combining both agents on day 1. If the MTD has not been determined after completion of the 6th cohort (dose level 6), based on an overall review of toxicity at each cohort, the Investigator may select a dose thought to be the recommended dose for Phase 2 studies. Six patients treated at MTD will undergo PK (pharmacokinetic) and PD (pharmacodynamic) evaluation. An additional cohort of 14-20 patients will be enrolled at either the MTD or at the recommended Phase 2 dose level administering both drugs on day 1. During this portion of the study patients will be withdrawn from the study if any of the following occur:
- Patient or patient's legally acceptable representative decides to withdraw consent.
- Patient's response to therapy is unsatisfactory, as evidenced by progression of disease as defined by RECIST Criteria for Tumor Response (within 2 cycles)
- The patient experiences toxicities deemed possibly or probably related to drug that have not resolved to at least Grade 2 or lower within three weeks.
- The patient requires more than one dose reduction because of toxicities attributable to ABT-751.
- The patient requires during the study period alternate antineoplastin agent, concurrent radiotherapy or surgery of the only measurable site(s) of disease.
- The patient becomes pregnant or begins to breast-feed.
- The investigator believes it is in the best interest of the patient to discontinue study drug administration.
If grade 3 or higher toxicities develop in 2 or more out of the first 6 patients who receive both drugs on day 1 on a dose level at which no such toxicities were noted on the ABT-751 day 1/carboplatin day 4 schedule, the additional patients for the second portion of the study will receive the latter schedule.
If toxicities characteristic of carboplatin (myelosuppression and others) are observed at the AUC 6 dose, carboplatin dose will be lowered to AUC 4.5 and the following dose escalation schema will be employed, beginning at the same ABT-751 dose as the one at which the toxicity developed:
All patients should receive antiemetics prior to carboplatin. A regimen of dexamethasone 10 mg and dolasetron 100 mg IV prior to carboplatin infusion may be used.
The study enrollment will be limited to patients with advanced NSCLC. Treatment will continue until progression of disease, unacceptable toxicities or withdrawal of informed consent. Male and female cancer patients will be selected to participate in the study according to the selection criteria.
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer
- Being tested
- ABT-751 and Carboplatin
- Keywords
- Lung Cancer, Advanced Lung Cancer, NSCLC
- Medical subject headings
- 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.
ABT-751 and CarboplatinDrug
Also called Paraplatin
This primary objective of this Phase 1/2 study is to evaluate the DLT and MTD of escalating oral doses of ABT-751 given BID on Day 1 of each cycle for 7 days in combination with carboplatin given on a 21-day schedule. The carboplatin dose is fixed at AUC 6 and will be administered on Day 4 during the first cycle to facilitate the pharmacokinetic analysis. During the subsequent cycles both agents will be administered on Day 1. ABT-751 is administered at the following dose levels using the Simon rapid dose escalation model: 100, mg, 125 mg, 150 mg, 175 mg and 200 mg BID.
| Study group | Role | What they receive |
|---|---|---|
| ABT-751 100 mg and Carboplatin | Experimental | 100 mg BID ABT-751 orally for 7 days. Carboplatin AUC 4.5 once every 21 days. Receives: Drug: ABT-751 and Carboplatin |
| ABT-751 125 mg and Carboplatin | Experimental | 125 mg BID ABT-751orally for 7 days. Carboplatin AUC 4.5 or 6 once every 21 days. Receives: Drug: ABT-751 and Carboplatin |
| ABT-751 150 mg and Carboplatin | Experimental | 150 mg BID ABT-751orally for 7 days. Carboplatin AUC 6 once every 21 days. Receives: Drug: ABT-751 and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of ABT-751 in Combination With Carboplatin
The maximum tolerated dose (MTD) of escalating ABT-751 in combination with fixed dose Carboplatin AUC 6 in patients with advanced non small cell lung cancer (NSCLC). Initially, 1 patient will be enrolled in dose level 1. If the patient experiences a Gr 2 toxicity, additional 2 patients will be enrolled at the dose level. If 1 of the 3 patients experience a Gr 3 toxicity or higher the cohort will be expanded to 6 patients. However, if 1 patient completes one cycle at the assigned dose regimen without a Gr 2 toxicity, enrollment in the next cohort (dose level 2) can begin. The rapid dose escalation scheme will apply to cohorts 1 through 3.
Measured: 21 Days (end of cycle 1)
Objective Response Rate of Participants Using A Combination of ABT-751 and Carboplatin
The effectiveness of the combination with ABT-751 and carboplatin in patients with advanced NSCLC as measured by objective response rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT or MRI: Complete Response (CR), The disappearance of all known disease determined by two observations not less than four weeks apart.; Partial Response (PR), At least a 30% or more decrease in total tumor load of the lesions that have been measured to determine the effect of therapy by two observations not less than four weeks apart.; Overall Response (OR) = CR + PR
Measured: 42 days (end of cycle 2)
The Median Survival in the Study Population
Median overall survival using the Kaplan Meier method
Measured: from the start of the study until the last subject dies (up to 100 weeks)
Secondary outcomes (2)
Pharmacokinetic Profile of ABT-751 for Phase 2
The pharmacokinetic profile of ABT-751 given in combination with carboplatin in a subset of patients, treated at the MTD or recommended doses for Phase 2.
Measured: Randomization to maximum tolerated dose confirmed
Number of Patients With Buccal Cells Demonstrating a Decline in Cyclin D1
Cyclin D1 levels were evaluated by immunoblot analyses of pretreatment (day 0) and paired posttreatment (day 4, 8 and 22) buccal swabs.
Measured: pretreatment (Day 0) and patient paired post- treatment (Days 4,8, 22) buccal swabs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startSep 2004
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: data from a similar did not show efficacy.
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konstantin Dragnev
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor-investigator, Konstantin Dragnev, Dartmouth-Hitchcock Medical Center
- Investigators
- Konstantin H Dragnev, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735878
- Sponsor's protocol ID
- D0412
- Status last verified
- Oct 2018
- First submitted
- 13 Aug 2008
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ma T, Fuld AD, Rigas JR, Hagey AE, Gordon GB, Dmitrovsky E, Dragnev KH. A phase I trial and in vitro studies combining ABT-751 with carboplatin in previously treated non-small cell lung cancer patients. Chemotherapy. 2012;58(4):321-9. doi: 10.1159/000343165. Epub 2012 Nov 12.
PubMed 23147218
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Pharmacokinetic and Pharmacodynamic Study of ABT-751 in Combination With Carboplatin in Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT00735878
- Acronym / sponsor ID
- D0412
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer
- Keywords
- Lung Cancer, Advanced Lung Cancer, NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: data from a similar did not show efficacy.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Konstantin DragnevUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Sep 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Posted 12 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
The primary objectives of this study are as follows:
- To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of escalating ABT-751 in combination with fixed dose carboplatin in patients with advanced non small cell lung cancer (NSCLC).
- To evaluate the efficacy of the combination with ABT-751 and carboplatin in patients with advanced NSCLC
- To determine the median survival in the study population
Secondary Objectives
The secondary objectives are:
- To characterize the pharmacokinetic profile of ABT-751 given in combination with carboplatin in a subset of patients, treated at the MTD or recommended doses for Phase 2.
- To determine the pharmacodynamics of ABT-751 as a single agent and the combination of ABT-751 and carboplatin as evaluated by cell cycle analysis of buccal mucosa cells.
Detailed description
This primary objective of this Phase 1/2 study is to evaluate the DLT and MTD of escalating oral doses of ABT-751 given BID (twice daily) on Day 1 of each cycle for 7 days in combination with carboplatin given on a 21-day schedule. The carboplatin dose is fixed at AUC 6 and will be administered on Day 4 during the first cycle to facilitate the pharmacokinetic analysis. During the subsequent cycles both agents will be administered on Day 1. ABT-751 is administered at the following dose levels using the Simon rapid dose escalation model: 100, mg, 125 mg, 150 mg, 175 mg and 200 mg BID.
Initially, 1 patient will be enrolled in dose level 1. If the patient experiences a Grade 2 toxicity, an additional 2 patients will be enrolled at the same dose level. If 1 of the 3 patients experiences a Grade 3 (or higher toxicity), the cohort will be expanded to 6 patients. However, if 1 patient completes one cycle at the assigned dose regimen without experiencing a Grade 2 toxicity, enrollment in the next cohort (dose level 2) can begin. This rapid dose escalation scheme will apply to cohorts 1 through 3.
Initially, in the 4th cohort (dose level 4), a minimum of three patients will be enrolled. If 1 of the 3 patients experiences a Grade 3 (or higher toxicity), the cohort will be expanded to 6 patients. However, if 3 patients complete one cycle at the assigned dose regimen without experiencing a Grade 3 (or higher toxicity), enrollment in the next cohort (dose level 5) can begin. This scheme will apply to cohorts 4, 5, and 6 MTD is defined as the highest dose of ABT-751 given in combination with carboplatin at which fewer than 33% of patients experience DLT. MTD will be evaluated at the end of the first cycle (21 days). Toxicities will be determined also at the end of cycle 2 to evaluate the safety of combining both agents on day 1. If the MTD has not been determined after completion of the 6th cohort (dose level 6), based on an overall review of toxicity at each cohort, the Investigator may select a dose thought to be the recommended dose for Phase 2 studies. Six patients treated at MTD will undergo PK (pharmacokinetic) and PD (pharmacodynamic) evaluation. An additional cohort of 14-20 patients will be enrolled at either the MTD or at the recommended Phase 2 dose level administering both drugs on day 1. During this portion of the study patients will be withdrawn from the study if any of the following occur:
- Patient or patient's legally acceptable representative decides to withdraw consent.
- Patient's response to therapy is unsatisfactory, as evidenced by progression of disease as defined by RECIST Criteria for Tumor Response (within 2 cycles)
- The patient experiences toxicities deemed possibly or probably related to drug that have not resolved to at least Grade 2 or lower within three weeks.
- The patient requires more than one dose reduction because of toxicities attributable to ABT-751.
- The patient requires during the study period alternate antineoplastin agent, concurrent radiotherapy or surgery of the only measurable site(s) of disease.
- The patient becomes pregnant or begins to breast-feed.
- The investigator believes it is in the best interest of the patient to discontinue study drug administration.
If grade 3 or higher toxicities develop in 2 or more out of the first 6 patients who receive both drugs on day 1 on a dose level at which no such toxicities were noted on the ABT-751 day 1/carboplatin day 4 schedule, the additional patients for the second portion of the study will receive the latter schedule.
If toxicities characteristic of carboplatin (myelosuppression and others) are observed at the AUC 6 dose, carboplatin dose will be lowered to AUC 4.5 and the following dose escalation schema will be employed, beginning at the same ABT-751 dose as the one at which the toxicity developed:
All patients should receive antiemetics prior to carboplatin. A regimen of dexamethasone 10 mg and dolasetron 100 mg IV prior to carboplatin infusion may be used.
The study enrollment will be limited to patients with advanced NSCLC. Treatment will continue until progression of disease, unacceptable toxicities or withdrawal of informed consent. Male and female cancer patients will be selected to participate in the study according to the selection criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABT-751 100 mg and Carboplatin | Experimental | Drug: ABT-751 and Carboplatin100 mg BID ABT-751 orally for 7 days. Carboplatin AUC 4.5 once every 21 days. |
| ABT-751 125 mg and Carboplatin | Experimental | Drug: ABT-751 and Carboplatin125 mg BID ABT-751orally for 7 days. Carboplatin AUC 4.5 or 6 once every 21 days. |
| ABT-751 150 mg and Carboplatin | Experimental | Drug: ABT-751 and Carboplatin150 mg BID ABT-751orally for 7 days. Carboplatin AUC 6 once every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- At least 18 years of age.
- Pathologically or cytologically confirmed diagnosis of NSCLC .
- At least one measurable lesion (not amenable to resection) for Response Evaluation Criteria in Solid Tumors (RECIST) tumor assessments. Target lesions must not have been in the previous radiation port.
- Advanced stage of disease (IIIB with malignant pleural effusion or Stage IV) with no known curative treatment that has progressed despite therapy for recurrent/metastatic disease or prior therapy was discontinued due to intolerable toxicities. During the phase II portion of the study, previously untreated patients with IIIB with malignant pleural effusion or Stage IV NSCLC may be enrolled.
- For patients participating in the phase I part of the study, no alternative therapy is available that is expected to prolong overall or progression-free survival. Unacceptable toxicities during first- or second-line therapy or evidence for disease progression.
Key exclusion criteria (16 listed)
- Any other malignancy within 3 years except in situ carcinoma.
- Untreated central nervous system (CNS) metastasis.
- A greater than Grade 1 National Cancer Institute Common Toxicity Criteria (NCI CTC) neurology category findings at baseline.
- Concurrent anti-cancer therapy or radiotherapy.
- Concurrent therapy with colchicines.
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 |
|---|---|---|
| ABT-751 and CarboplatinAlso: ParaplatinThis primary objective of this Phase 1/2 study is to evaluate the DLT and MTD of escalating oral doses of ABT-751 given BID on Day 1 of each cycle for 7 days in combination with carboplatin given on a 21-day schedule. The carboplatin dose is fixed at AUC 6 and will be administered on Day 4 during the first cycle to facilitate the pharmacokinetic analysis. During the subsequent cycles both agents will be administered on Day 1. ABT-751 is administered at the following dose levels using the Simon rapid dose escalation model: 100, mg, 125 mg, 150 mg, 175 mg and 200 mg BID. | Drug | ABT-751 100 mg and Carboplatin, ABT-751 125 mg and Carboplatin, ABT-751 150 mg and Carboplatin |
Primary outcome
Maximum Tolerated Dose (MTD) of ABT-751 in Combination With Carboplatin
Time frame: 21 Days (end of cycle 1)
The maximum tolerated dose (MTD) of escalating ABT-751 in combination with fixed dose Carboplatin AUC 6 in patients with advanced non small cell lung cancer (NSCLC). Initially, 1 patient will be enrolled in dose level 1. If the patient experiences a Gr 2 toxicity, additional 2 patients will be enrolled at the dose level. If 1 of the 3 patients experience a Gr 3 toxicity or higher the cohort will be expanded to 6 patients. However, if 1 patient completes one cycle at the assigned dose regimen without a Gr 2 toxicity, enrollment in the next cohort (dose level 2) can begin. The rapid dose escalation scheme will apply to cohorts 1 through 3.
Objective Response Rate of Participants Using A Combination of ABT-751 and Carboplatin
Time frame: 42 days (end of cycle 2)
The effectiveness of the combination with ABT-751 and carboplatin in patients with advanced NSCLC as measured by objective response rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT or MRI: Complete Response (CR), The disappearance of all known disease determined by two observations not less than four weeks apart.; Partial Response (PR), At least a 30% or more decrease in total tumor load of the lesions that have been measured to determine the effect of therapy by two observations not less than four weeks apart.; Overall Response (OR) = CR + PR
The Median Survival in the Study Population
Time frame: from the start of the study until the last subject dies (up to 100 weeks)
Median overall survival using the Kaplan Meier method
2 secondary outcomes
Pharmacokinetic Profile of ABT-751 for Phase 2
Time frame: Randomization to maximum tolerated dose confirmed
Number of Patients With Buccal Cells Demonstrating a Decline in Cyclin D1
Time frame: pretreatment (Day 0) and patient paired post- treatment (Days 4,8, 22) buccal swabs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23147218Ma T, Fuld AD, Rigas JR, Hagey AE, Gordon GB, Dmitrovsky E, Dragnev KH. A phase I trial and in vitro studies combining ABT-751 with carboplatin in previously treated non-small cell lung cancer patients. Chemotherapy. 2012;58(4):321-9. doi: 10.1159/000343165. Epub 2012 Nov 12.
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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.
Konstantin H Dragnev, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABT-751 and Carboplatin in people with Non Small Cell Lung Cancer and Lung Cancer, run by Konstantin Dragnev 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 12 inclusion and 16 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 12 Oct 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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 12 Oct 2018). 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?
Maximum Tolerated Dose (MTD) of ABT-751 in Combination With Carboplatin (time frame: 21 Days (end of cycle 1)). The study lists 3 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 NCT00735878, 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 12 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.