Solid TumorsPhase 1NCT00878449

A Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer

A Phase 1 study testing ABT-263 and etoposide/cisplatin in people with Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 1 Study Evaluating the Safety of ABT-263 in Combination with Etoposide/Cisplatin in Subjects with Small Cell Lung Cancer (SCLC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors
What is being tested?: ABT-263 and etoposide/cisplatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 7 sitesUnited States
Study dates: Oct 2009to Jul 2011
Phase: Phase 1
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

Must be greater then or equal to18 years of age;
For dose escalation subject must have histologically and/or cytologically documented cancer for which etoposide/cisplatin has been determined to be an appropriate therapy. For expanded safety cohort subject must have histologically and/or cytologically documented SCLC for which etoposide/cisplatin has been determined an appropriate therapy;
Subject has an ECOG performance score of less then or equal to 1; Evaluable and/or measurable disease by CT or MRI per RECIST criteria;
Subjects with brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the 1st dose of study drug;
Must have adequate renal and hepatic function, per local laboratory reference range at Screening as follows:
ANC greater then or equal to 1500/mcL,

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Platelets greater then or equal to 150,000/mm^3,
Hemoglobin greater then or equal to 10.0 g/dL,
Serum creatinine less then or equal to 1.5 mg/dL or calculated creatinine clearance greater then or equal to 50 mL/min; Na greater then 130 mmol/L,
Alkaline Phosphatase, AST and ALTless then or equal to 2.5 x ULN ;Bilirubin less then or equal to 1.5 x ULN.Subjects with liver mets may have ALP, AST and ALT less then or equal to 5.0 x ULN, Subjects with bone mets may have Alkaline Phosphatase less then or equal to 5.0 x ULN,
Subjects with Gilbert's Syndrome may have a Bilirubin greater then 1.5 x ULN,
Coagulation: aPTT, PT, less then or equal to 1.2 x ULN;
Life expectancy of at least 30 days;
Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or have negative results for a pregnancy test;
Female subjects not surgically sterile or postmenopausal (for at least one year) and non-vasectomized male subjects must practice at least one method of birth control.

Who cannot join

Subject exhibits evidence of other uncontrolled condition(s) including, but not limited to: active systemic infection, diagnosis of fever or neutropenia within 1 week of 1st dose;
Subject has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding;
Subject is currently receiving or requires anticoagulation therapy;
Subject has active immune thrombocytopenic purpura, autoimmune hemolytic anemia or a history of being refractory to platelet transfusions (within 1 year prior to 1st dose of study drug);
Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis;
Subject has a significant history of CV disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease;

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Female subject is pregnant or breast-feeding;
Subject has tested positive for HIV;
Subject has a history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent;
Subject has received any anti-cancer therapy within 14 days prior to 1st dose of study drug;
Subject has received steroid therapy for anti-neoplastic intent within 7 days prior to 1st dose of study drug;
Subject has received aspirin within 7 days prior to 1st dose of study drug;
Subject has received radio-immunotherapy within 6 months prior to 1st dose of study drug; Subject has received an antibody therapy or other biologics (with the exception of colony stimulating factors [G-CSF,GM-CSF] or erythropoietin) within 28 days prior to 1st dose of study drug;
Subject has a hypersensitivity to platinum-containing compounds or etoposide;
Subject has consumed grapefruit within 3 days prior to 1st dose of study drug.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Site Reference ID/Investigator# 12303
Baltimore, Maryland, 21231
Site Reference ID/Investigator# 12305
Boston, Massachusetts, 02215
Site Reference ID/Investigator# 20381
Boston, Massachusetts, 02215
Site Reference ID/Investigator# 13323
Chicago, Illinois, 60637
Site Reference ID/Investigator# 43505
Detroit, Michigan, 48202
Site Reference ID/Investigator# 12841
Maywood, Illinois, 60153
Site Reference ID/Investigator# 13322
New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Official title: A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer

This is a Phase 1 Study Evaluating the Safety of ABT-263 in Combination with Etoposide/Cisplatin in Subjects with Small Cell Lung Cancer (SCLC).

Conditions: Solid Tumors
Being tested: ABT-263, etoposide/cisplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-263Drug
150mg of ABT-263 is taken daily for 3 out of 21 days. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
etoposide/cisplatinDrug
etoposide = 100 mg/m2 Days 1-3 of each Cycle; Max duration 6 cycles. cisplatin = 75 mg/m2 Day 1 of each Cycle; Max duration 6 cycles

Study groups in NCT00878449
Study group	Role	What they receive
ABT-263 + etoposide/cisplatin	Experimental	Not described Receives: Drug: ABT-263; Drug: etoposide/cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Assess the safety profile of ABT-263 when administered in combination with etoposide/cisplatin in subjects with Cancer.
Measured: Weekly
Characterize the pharmacokinetics of ABT-263 when administered in combination with etoposide/cisplatin .
Measured: Weekly
Determine the maximum tolerable dose (MTD) of ABT-263 when administered in combination with etoposide/cisplatin.
Measured: Weekly
Determine the recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with etoposide/cisplatin.
Measured: Weekly

Secondary outcomes (7)

Evaluate preliminary data regarding progression free survival (PFS).
Measured: Bi-monthly
Evaluate preliminary data regarding objective response rate (ORR).
Measured: Bi-monthly
Evaluate preliminary data regarding time to tumor progression (TTP).
Measured: Bi-monthly
Evaluate preliminary data regarding overall survival (OS).
Measured: Bi-monthly
Evaluate preliminary data regarding duration of overall response.
Measured: Bi-monthly
Evaluate preliminary data regarding Eastern Cooperative Oncology Group (ECOG) performance status.
Measured: Bi-monthly
Evaluate biomarkers
Define the relationship between disease state (related to patient selection and monitoring), B-Cell Lymphoma 2 (Bcl-2) family protein expression, and potential response to the proposed therapy ABT-263 and etoposide/cisplatin.
Measured: Bi-monthly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Jul 2011

First posted9 Apr 2009 (estimated)
Study startOct 2009
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00878449
Sponsor's protocol ID: M10-234
Status last verified: Jan 2013
First submitted: 7 Apr 2009
Last updated: 6 Jun 2018
Results posted: No

Publications

Pietanza MC, Rudin CM. Novel therapeutic approaches for small cell lung cancer: the future has arrived. Curr Probl Cancer. 2012 May-Jun;36(3):156-73. doi: 10.1016/j.currproblcancer.2012.03.005. Epub 2012 Apr 10. No abstract available.
PubMed 22495056

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Etoposide/Cisplatin in Subjects With Cancer
ClinicalTrials.gov ID: NCT00878449
Acronym / sponsor ID: M10-234
Conditions: Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Genentech, Inc.
Study start: Oct 2009
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 9 Apr 2009 (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.

This is a Phase 1 Study Evaluating the Safety of ABT-263 in Combination with Etoposide/Cisplatin in Subjects with Small Cell Lung Cancer (SCLC).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ABT-263 + etoposide/cisplatin	Experimental	Drug: ABT-263, Drug: etoposide/cisplatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Must be greater then or equal to18 years of age;
For dose escalation subject must have histologically and/or cytologically documented cancer for which etoposide/cisplatin has been determined to be an appropriate therapy. For expanded safety cohort subject must have histologically and/or cytologically documented SCLC for which etoposide/cisplatin has been determined an appropriate therapy;
Subject has an ECOG performance score of less then or equal to 1; Evaluable and/or measurable disease by CT or MRI per RECIST criteria;
Subjects with brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the 1st dose of study drug;
Must have adequate renal and hepatic function, per local laboratory reference range at Screening as follows:

Key exclusion criteria (15 listed)

Subject exhibits evidence of other uncontrolled condition(s) including, but not limited to: active systemic infection, diagnosis of fever or neutropenia within 1 week of 1st dose;
Subject has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding;
Subject is currently receiving or requires anticoagulation therapy;
Subject has active immune thrombocytopenic purpura, autoimmune hemolytic anemia or a history of being refractory to platelet transfusions (within 1 year prior to 1st dose of study drug);
Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis;

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-263150mg of ABT-263 is taken daily for 3 out of 21 days. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.	Drug	ABT-263 + etoposide/cisplatin
etoposide/cisplatinetoposide = 100 mg/m2 Days 1-3 of each Cycle; Max duration 6 cycles. cisplatin = 75 mg/m2 Day 1 of each Cycle; Max duration 6 cycles	Drug	ABT-263 + etoposide/cisplatin

Primary outcome

Assess the safety profile of ABT-263 when administered in combination with etoposide/cisplatin in subjects with Cancer.
Time frame: Weekly
Characterize the pharmacokinetics of ABT-263 when administered in combination with etoposide/cisplatin .
Time frame: Weekly
Determine the maximum tolerable dose (MTD) of ABT-263 when administered in combination with etoposide/cisplatin.
Time frame: Weekly
Determine the recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with etoposide/cisplatin.
Time frame: Weekly

7 secondary outcomes

Evaluate preliminary data regarding progression free survival (PFS).
Time frame: Bi-monthly
Evaluate preliminary data regarding objective response rate (ORR).
Time frame: Bi-monthly
Evaluate preliminary data regarding time to tumor progression (TTP).
Time frame: Bi-monthly
Evaluate preliminary data regarding overall survival (OS).
Time frame: Bi-monthly
Evaluate preliminary data regarding duration of overall response.
Time frame: Bi-monthly
Evaluate preliminary data regarding Eastern Cooperative Oncology Group (ECOG) performance status.
Time frame: Bi-monthly
Evaluate biomarkers
Time frame: Bi-monthly

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Background: PubMed 22495056Pietanza MC, Rudin CM. Novel therapeutic approaches for small cell lung cancer: the future has arrived. Curr Probl Cancer. 2012 May-Jun;36(3):156-73. doi: 10.1016/j.currproblcancer.2012.03.005. Epub 2012 Apr 10. No abstract available.

Related trials for Solid Tumors

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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

Mack Mabry, MD study director

AbbVie

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-263 and etoposide/cisplatin in people with Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 7 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 15 inclusion and 15 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assess the safety profile of ABT-263 when administered in combination with etoposide/cisplatin in subjects with Cancer. (time frame: Weekly). The study lists 4 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 NCT00878449, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.