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Solid TumorsPhase 1NCT01009073

A Study Evaluating ABT-263 With Erlotinib, ABT-263 With Irinotecan, and ABT-263 Monotherapy in Cancer Subjects

A Phase 1 study testing ABT-263, erlotinib and irinotecan (3-week schedule) in people with Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 4 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 three arm study to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with erlotinib (Arm A), to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with irinotecan (Arm B), and to evaluate safety of ABT-263 monotherapy (Arm C). 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, erlotinib and irinotecan (3-week schedule)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
4 sitesUnited States
Study dates
Oct 2009to Jun 2013
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

  • Greater than or equal to 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
  • 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 1 year) and non vasectomized male subjects must practice at least one method of birth control.
  • Arm A (ABT-263 and Erlotinib) and B (ABT-263 and Irinotecan) do not require prior ABT-263 exposure, however, for Arm C (ABT-263 monotherapy), subjects must have completed at least one dose of ABT-263 during a previous study.
  • For Arm A (ABT-263 and Erlotinib) and Arm B (ABT-263 and Irinotecan), subjects should have histologically and/or cytologically documented cancer for which irinotecan or erlotinib has been determined to be an appropriate therapy as determined by the Investigator.
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  • For Arm C (ABT 263 monotherapy), subject should have a malignancy that is either relapsed or refractory to standard therapy or no known effective therapy exists.
  • Adequate bone marrow, renal and hepatic function per local laboratory reference range as follows: * Bone marrow: Absolute Neutrophil count (ANC) greater than or equal to 1,000/microliter; Platelets greater than or equal to 100,000/mm raised to the 3rd power (Greater than or equal to 150,000/mm raised to the 3rd power for irinotecan combination) independent of platelet transfusions within 3 months prior to starting study drug; Hemoglobin greater than or equal to 9.0 grams/deciliter; * Renal function: serum creatinine less than or equal to 2.0 milligrams/deciliter or calculated creatinine clearance greater than or equal to 50 milliliter/minute; * Hepatic function and enzymes: AST and ALT less than or equal to 3.0 multiplied by the upper normal limit (ULN) of institution's normal range; Bilirubin less than or equal to 1.5 multiplied by ULN. Subjects with Gilbert's Syndrome may have a Bilirubin Greater than 1.5 multiplied by ULN; Subjects with liver metastasis may have AST and ALT of less than or equal to 5.0 multiplied by the upper limit of normal; * Coagulation: aPTT, PT not to exceed 1.2 multiplied by ULN.
  • Subjects with neurologic symptoms (e.g., visual problems, headache, seizure) must have documented brain imaging (MRI or CT) within 28 days prior to the first dose of study drug. If imaging is performed, then subject should be negative for subdural or epidural hematoma. Subjects with brain metastases must have clinically controlled symptoms as 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 first dose of study drug.
  • Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics committee (IEC)/Institutional Review board (IRB), prior to the initiation of any screening or study-specific procedures.

Who cannot join

  • Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
  • Subject has a significant history of cardiovascular disease (e.g., MI, thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study. Question regarding inclusion of individual subjects should be directed to the Abbott Medical Monitor or designee.
  • Female subject is pregnant or breast-feeding.
  • Subject has tested positive for HIV (due to potential drug-drug interactions between anti retroviral inhibitors and ABT-263, as well as anticipated ABT-263 mechanism based lymphopenia that may potentially increase the risk of opportunistic infections and potential drug drug interactions with certain anti-infective agents).
  • Subject exhibits evidence of other clinically significant uncontrolled conditions(s) including, but not limited to: * active systemic fungal infection; * diagnosis of fever and neutropenia within 1 week prior to study drug administration.
  • Subject has received any of the following anti-cancer therapy 14 days prior to the first dose of study drug, or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy: * chemotherapy, immunotherapy, radiotherapy; * hormonal (with the exception of hormones for hypothyroidism or estrogen replacement therapy [ERT], or agonists required to suppress serum testosterone levels [e.g., LHRH, GnRH, etc.] for subjects with prostate cancer if on a stable dose for 21 days prior to the first dose of study drug); * any investigational therapy other than ABT-263, including targeted small molecule agents.
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  • Subject has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
  • Subject is currently receiving or requires anticoagulation therapy (e.g., warfarin at any dose) or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications such as heparin that are used to maintain the patency of a catheter.
  • Subject has received aspirin or warfarin within 7 days prior to the first dose of study drug.
  • Subject has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
  • History of hypersensitivity to erlotinib or other polysorbate 80 drugs (not applicable for ABT 263 monotherapy).
  • Received potent CYP3A inhibitors (e.g., ketoconazole) within 7 days prior to the first dose of study drug.
  • Received ABT-263 within 3 days prior to the first dose of study drug (not applicable to ABT-263 monotherapy).
  • In the opinion of the Investigator, the subject is an unsuitable candidate to receive ABT 263.
  • Subject has received rifampin within 4 days prior to first dose of study drug in Arm A (ABT-263 and erlotinib) or Arm C (ABT-263 Monotherapy) and within 7 days prior to first dose of study drug in Arm B (ABT-263 and irinotecan).
  • Subjects who are UGT1A1*28 7/7 homozygous in Arm B (ABT-263 and irinotecan) of the study

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Site Reference ID/Investigator# 36342

    Detroit, Michigan, 48201

  • Site Reference ID/Investigator# 24046

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 37463

    Santa Monica, California, 90404

  • Site Reference ID/Investigator# 44917

    Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-263 in Combination With Erlotinib and ABT-263 in Combination With Irinotecan, and Evaluating the Safety of ABT-263 Monotherapy in Subjects With Cancer

This is a three arm study to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with erlotinib (Arm A), to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with irinotecan (Arm B), and to evaluate safety of ABT-263 monotherapy (Arm C).

Conditions
Solid Tumors
Being tested
ABT-263, erlotinib, irinotecan (3-week schedule), irinotecan (weekly schedule)

What participants receive

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

  • ABT-263Drug

    ABT-263 is taken orally.

    Note - The dose and schedule is variable based on Arm and subject to change based on the toxicities observed.

  • erlotinibDrug

    150 mg of erlotinib is taken orally once daily.

  • irinotecan (3-week schedule)Drug

    180 mg/m2 over 90 minutes, irinotecan will be given by intravenous infusion on Day 1 of each 21 day cycle.

    Note - The dose and schedule is subject to change based on the toxicities observed.

  • irinotecan (weekly schedule)Drug

    75 mg/m2 over 45 minutes, irinotecan will be given by intravenous infusion on Days 1 and 8 of each 21 day cycle.

    Note - The dose and schedule is subject to change based on the toxicities observed.

Study groups in NCT01009073
Study groupRoleWhat they receive
Arm A (ABT-263 and erlotinib)ExperimentalNot described
Receives: Drug: ABT-263; Drug: erlotinib
Arm B (ABT-263 and irinotecan)ExperimentalNot described
Receives: Drug: ABT-263; Drug: irinotecan (3-week schedule); Drug: irinotecan (weekly schedule)
Arm C (ABT-263 monotherapy)ExperimentalNot described
Receives: Drug: ABT-263

What is being measured

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

  1. Arm A

    • assess the safety profile of ABT-263 in combination with erlotinib; • study the pharmacokinetic interaction between ABT-263 and erlotinib; • determine the maximum tolerated dose (MTD) of ABT-263 when administered with erlotinib

    Measured: Weekly

  2. Arm B

    • assess the safety profile of ABT-263 in combination with irinotecan; • study the pharmacokinetic interaction between ABT-263 and irinotecan; • determine the maximum tolerated dose (MTD) of ABT-263 when administered with irinotecan.s

    Measured: Weekly

  3. Arm C

    • assess the safety profile of ABT-263 as a monotherapy

    Measured: Weekly

Timeline

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

  1. First posted6 Nov 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJun 2013
  4. Study completionJun 2013

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
Parallel groups
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01009073
Sponsor's protocol ID
M11-958
Status last verified
Jun 2013
First submitted
19 Oct 2009
Last updated
20 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Tolcher AW, LoRusso P, Arzt J, Busman TA, Lian G, Rudersdorf NS, Vanderwal CA, Kirschbrown W, Holen KD, Rosen LS. Safety, efficacy, and pharmacokinetics of navitoclax (ABT-263) in combination with erlotinib in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Nov;76(5):1025-32. doi: 10.1007/s00280-015-2883-8. Epub 2015 Sep 29.

    PubMed 26420235

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-263, erlotinib and irinotecan (3-week schedule) in people with Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 4 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 10 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: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Arm A (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 NCT01009073, 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 20 Nov 2017.

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