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Solid TumorsPhase 1NCT00887757

Safety Study of ABT-263 in Combination With Gemzar (Gemcitabine) in Subjects With Solid Tumors

A Phase 1 study testing ABT-263 and gemcitabine in people with Solid Tumors, run by AbbVie.

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 open-label study evaluating the safety of navitoclax (ABT-263) when combined with a standard regimen of gemcitabine in approximately 50 subjects with solid tumors and measurable disease. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Solid Tumors
What is being tested?
ABT-263 and gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
Sep 2009to Nov 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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age greater then or equal to 18 years.
  • For the 21 and 28-day dose escalation cohorts and the 21-day safety expansion cohort subjects must have histologically and/or cytologically documented cancer for which gemcitabine has been determined to be an appropriate therapy, per the Investigator.
  • For the 28-day safety expansion cohort, subjects must have histologically and/or cytologically documented ductal adenocarcinoma or undifferentiated carcinoma of the pancreas for which gemcitabine has been determined to be an appropriate first-line therapy, per the investigator.
  • Note: If the 28-day dose escalation schedule is deemed intolerable and further dose de-escalation is not explored, the expanded safety cohort will evaluate navitoclax (ABT-263) in combination with gemcitabine in an additional 12 to 15 subjects with histologically ductal adenocarcinoma or undifferentiated carcinoma of the pancreas for which gemcitabine has been determined to be an appropriate first-line therapy with the RPTD and schedule from the 21-day portion of the study.
  • Measurable disease by CT or MRI as defined RECIST.
  • 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 28 days prior to the 1st dose of study drug.
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  • ECOG less then or equal to 1.
  • Must have adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:
  • Bone marrow:Absolute Neutrophil Count greater then or equal to1500/μL; platelets greater then or equal to 150,000/mm^3; hemoglobin greater then or equal to 9.0 g/dL;
  • Renal function: Serum creatinine less then or equal to 2.0 mg/dL or calculated creatinine clearance greater then or equal to 50 mL/min;
  • Hepatic function and enzymes: AST , ALP and ALT less then or equal to 3.0 × the upper limit of normal (ULN), bilirubin less then or equal to 1.5 × ULN.
  • Subjects with liver metastasis may have AST, ALP, and ALT less then or equal to 5.0 X ULN.
  • Subjects with bone metastasis may have ALP less then or equal to 5.0 × ULN; Coagulation: aPTT and PT not to exceed 1.2 × ULN.
  • Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or have negative results for a pregnancy test performed as follows: at Screening via serum sample obtained within 14 days prior to initial study drug administration and prior to dosing via urine sample obtained on Cycle 1 Day 1, if it has been greater then 7 days since obtaining the serum pregnancy test results.
  • Female subjects not surgically sterile or postmenopausal (for at least 1 year) and non-vasectomized male subjects must practice at least 1 of the following methods of birth control:
  • total abstinence from sexual intercourse (minimum 1 complete menstrual cycle);
  • vasectomized partner;
  • hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration;
  • Double-barrier method (including condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream).

Who cannot join

  • Underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
  • Recent history of thrombocytopenia associated with bleeding w/i 1 year prior to 1st dose of study drug.
  • Currently receiving or requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, w/the exception of low-dose anticoagulation medications that are used to maintain the patency of a central iv catheter.
  • Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
  • Active immune thrombocytopenic purpura, autoimmune hemolytic anemia or a history of being refractory to platelet transfusions (w/i 1 year prior to the 1st dose of study drug).
  • Received radio-immunotherapy w/i 6 months prior to 1st dose of study drug.
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  • Received an antibody therapy or other biologics (with the exception of colony stimulating factors [G-CSF,GM-CSF] or erythropoietin) w/i 28 days prior to 1st dose of study drug.
  • Received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal therapy (with the exception of hormones for hypothyroidism, ERT, anti-estrogen analogs, LHRH, GnRH agonists required to suppress serum testosterone levels if on a stable dose for at least 21 days prior to the 1st dose of study drug), or any investigational therapy w/i 14 days prior to the 1st dose of study drug, or has not recovered to less than a grade 2 clinically significant adverse effect(s)/ toxicity(s) of the previous therapy.
  • Received steroid therapy for anti-neoplastic intent w/i 7 days prior to the 1st dose of study drug. (Inhaled steroids for asthma, topical steroids, replacement/stress corticosteroids, or corticosteroids taken as premedication for this study will not be considered exclusionary).
  • Received aspirin w/i 7 days prior to 1st dose of study drug.
  • History of hypersensitivity to gemcitabine.Positive for HIV.
  • Significant history of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease.
  • Exhibits evidence of other clinically significant uncontrolled condition; active systemic fungal infection;diagnosis of fever \& neutropenia w/i 1 week prior to study drug administration.
  • The subject has undergone prior procedures or has active gastrointestinal disease that would result in the inability to adequately absorb an oral medication (e.g., uncontrolled nausea, vomiting, inflammatory disease, bowel obstruction, or a major bowel resection).

About this study

Official title: A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Gemzar® (Gemcitabine) in the Treatment of Subjects With Solid Tumors

This is a Phase 1 open-label study evaluating the safety of navitoclax (ABT-263) when combined with a standard regimen of gemcitabine in approximately 50 subjects with solid tumors and measurable disease.

Conditions
Solid Tumors
Being tested
ABT-263, gemcitabine

What participants receive

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

  • ABT-263Drug

    Also called navitoclax

    150mg of ABT-263 is taken orally once daily on Days 1-3 and Days 8-10 out of each 21 day cycle.

    325 mg of ABT-263 is taken orally once daily on days 1-3, 8-10, 15-17 out of each 28 day cycle.

    This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.

  • gemcitabineDrug

    Also called gemzar, gemcitabine

    Gemcitabine 1000 mg/m2 will be given by intravenous infusion on Day 1 and Day 8 of each 21 day cycle. Gemcitabine 1000 mg/m2 will be given by intravenous infusion on days 1, 8 and 15 of each 28 day cycle.

Study groups in NCT00887757
Study groupRoleWhat they receive
gemcitabine +ABT-263ExperimentalNot described
Receives: Drug: ABT-263; Drug: gemcitabine

What is being measured

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

  1. Assess the safety profile of ABT-263 in combination with gemcitabine.

    Measured: Weekly

  2. Study the pharmacokinetic interaction between ABT-263 and gemcitabine.

    Measured: Weekly

  3. Determine the maximum tolerated dose (MTD) of ABT-263 in combination with gemcitabine.

    Measured: Weekly

Secondary outcomes (8)

  1. Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule in combination with a standard and weekly regimen of gemcitabine.

    Measured: Bi-monthly

  2. Evaluate preliminary data regarding progression free survival (PFS)

    Measured: Bi-monthly

  3. Evaluate preliminary data regarding objective response rate (ORR)

    Measured: Bi-monthly

  4. Evaluate preliminary data regarding time to tumor progression (TTP)

    Measured: Bi-monthly

  5. Evaluate preliminary data regarding overall survival (OS)

    Measured: Bi-monthly

  6. Evaluate preliminary data regarding duration of overall response

    Measured: Bi-monthly

  7. Evaluate preliminary data with Eastern Cooperative Oncology Group (ECOG) performance status

    Measured: Bi-monthly

  8. Evaluate biomarkers to

    Define the relationship between disease states, B-Cell Lymphoma 2 (Bcl-2) family protein expression, and potential response to the proposed therapy navitoclax when added to a standard and weekly regimen of gemcitabine.

    Measured: Bi-monthly

Timeline

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

  1. First posted24 Apr 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00887757
Sponsor's protocol ID
M10-588
Status last verified
Dec 2011
First submitted
23 Apr 2009
Last updated
21 Nov 2017
Results posted
No

Publications

  • Cleary JM, Lima CM, Hurwitz HI, Montero AJ, Franklin C, Yang J, Graham A, Busman T, Mabry M, Holen K, Shapiro GI, Uronis H. A phase I clinical trial of navitoclax, a targeted high-affinity Bcl-2 family inhibitor, in combination with gemcitabine in patients with solid tumors. Invest New Drugs. 2014 Oct;32(5):937-45. doi: 10.1007/s10637-014-0110-9. Epub 2014 Jun 11.

    PubMed 24916770

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-263 and gemcitabine in people with Solid Tumors, run by AbbVie.

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 19 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: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

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 in combination with gemcitabine. (time frame: Weekly). 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 NCT00887757, 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 21 Nov 2017.

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