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Advanced Solid TumorsPhase 1NCT01110486

ABT-348 as Monotherapy or Combination With Carboplatin or Docetaxel to Treat Advanced Solid Tumors

A Phase 1 study testing ABT-348, ABT-348 and carboplatin and ABT-348 and docetaxel in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 2 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

The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated dose of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
ABT-348, ABT-348 and carboplatin and ABT-348 and docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
2 sitesUnited States
Study dates
Mar 2010to Sep 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological confirmation of locally advanced or metastatic solid tumor.
  • That is either refractory after standard of care therapy for the disease for which standard of care therapy is not reliably effective or does not exists, or
  • For which carboplatin has been determined to be an appropriate therapy, per the investigator, or
  • For which docetaxel has been determined to be an appropriate therapy, per the investigator.
  • Eastern Cooperative Oncology Group Status of 0-2
  • Serum creatinine value of ≤ 1.5 times the upper limit of normal (ULN) and either an estimated creatinine clearance value as determined by the Cockcroft-Gault formula or based on a 24 hour urine collection creatinine clearance value of ≥ 50 mL/min
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  • Adequate liver function as demonstrated by serum bilirubin < 2 x ULN and AST and ALT ≤ 2.5 x ULN
  • Adequate bone marrow as demonstrated by absolute neutrophil count (ANC) ≥ 1,500/mm2 (1.5 x 109/L); Platelets ≥ 100,000/mm2 (100 x 109/L); Hemoglobin ≥ 9.0 g/dL (1.4 mmol/L)
  • QTc interval < 500 msec
  • Left Ventricular Ejection Fraction > 50%
  • Women of child-bearing potential and men must agree to use adequate contraception (one of the following listed below) prior to the study entry, for the duration of study participation and up to 3 months following completion of therapy.
  • Capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study-specific procedures.

Who cannot join

  • Subject has known active CNS involvement. The subject has untreated brain or meningeal metastases.
  • Subject has received anti-cancer therapy within a period of 21 days or 5 half lives (whichever is shorter) prior to Study Day 1
  • Subject has unresolved toxicities from prior anti-cancer therapy, grade 2 or higher clinically significant toxicity (excluding alopecia)
  • Subject has had major surgery within 28 days prior to Study Day 1
  • Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 90 mmHg or systolic blood pressure > 140 mmHg
  • Subject has proteinuria grade > 1 7. Subject is receiving therapeutic anticoagulation therapy. Low dose anti coagulation (e.g., low dose heparin or warfarin) for catheter prophylaxis will be permitted.
  • 8. Clinically significant uncontrolled condition(s) 9.Psychiatric illness/social situation that would limit compliance with study requirements 10. Subject has a known infection with HIV, Hepatitis B or Hepatitis C 11. Subject with poorly controlled diabetes mellitus 12. Subject enrolled in Arm A, B, C and D is unable to swallow or absorb oral tablets normally 13. Any medical condition which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities 14. Female subjects who are lactating or pregnant 15. Subject enrolled in Arm E has hypersensitivity to drugs formulated with polyethoxylated castor oli (Cremophor)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Site Reference ID/Investigator# 26525

    Chicago, Illinois, 60637

  • Site Reference ID/Investigator# 26524

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-348 as Monotherapy, in Combination With Carboplatin or in Combination With Docetaxel in Subjects With Advanced Solid Tumors

The purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated dose of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel.

Read the detailed description

The primary purpose of this study is to determine the safety, pharmacokinetics and maximum tolerated dose of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel. The secondary purpose of this study is to evaluate safety at the recommended Phase 2 dose and evaluate preliminary efficacy data regarding objective response rate time to progression, duration of overall response, and ECOG performance status of ABT-348 as monotherapy and when given in combination with carboplatin or docetaxel.

Being tested
ABT-348, ABT-348 and carboplatin, ABT-348 and docetaxel

What participants receive

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

  • ABT-348Drug

    An oral dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.

  • ABT-348 and carboplatinDrug

    An oral dose of ABT-348 will begin in Cycle 2on Day 1 and Day 8; and an IV dose of carboplatin (AUC 5.0) on Day 1 of each 21-day cycle.

  • ABT-348 and docetaxelDrug

    ABT-348 dosing will begin in Cycle 2. An oral dose of ABT-348 on Day 1 and Day 8; and an IV dose of docetaxel (75 mg/m2) on Day 1 of each 21-day cycle.

  • ABT-348Drug

    An oral dose of ABT-348, twice daily on Day 1, Day 8, and Day 15 of each 28 day cycle

  • ABT-348Drug

    An IV administration of ABT-348 two hour infusion on Day 1, Day 8 and Day 15 of each 28 day cycle.

Study groups in NCT01110486
Study groupRoleWhat they receive
Monotherapy, once dailyExperimentalNot described
Receives: Drug: ABT-348
Combination with carboplatinExperimentalNot described
Receives: Drug: ABT-348 and carboplatin
Combination with docetaxelExperimentalNot described
Receives: Drug: ABT-348 and docetaxel
Monotherapy, twice dailyExperimentalNot described
Receives: Drug: ABT-348
IV Monotherapy, once dailyExperimentalNot described
Receives: Drug: ABT-348

What is being measured

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

  1. Determine the safety profile (Adverse events by toxicity grade and relationship to study drug, serious adverse events, adverse events leading to discontinuation and relevant clinical laboratory abnormalities) of ABT-348 as monotherapy or in combination

    Measured: At each treatment visit

  2. Study the pharmacokinetic of ABT-348

    Measured: At study visits

  3. Dose limiting toxicity determination

    Measured: At each treatment visit until dose-limiting toxicities observed

Secondary outcomes (2)

  1. Evaluate safety at the recommended Phase 2 dose (RPTD) and schedule of ABT-348 as monotherapy, when in combination with carboplatin or in combination with docetaxel.

    Measured: At RPTD treatment visit

  2. Evaluate preliminary efficacy data regarding objective response rate (ORR), time to progression (TTP), duration of overall response, and ECOG performance status of ABT-348 as monotherapy, when in combination with carboplatin or docetaxel.

    Measured: At each treatment visit

Timeline

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

  1. First posted26 Apr 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionSep 2013
  4. Study completionSep 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
Single group
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01110486
Sponsor's protocol ID
M10-944
Status last verified
Nov 2013
First submitted
26 Mar 2010
Last updated
6 Nov 2013
Results posted
No
Data monitoring committee
No

Publications

  • Maitland ML, Piha-Paul S, Falchook G, Kurzrock R, Nguyen L, Janisch L, Karovic S, McKee M, Hoening E, Wong S, Munasinghe W, Palma J, Donawho C, Lian GK, Ansell P, Ratain MJ, Hong D. Clinical pharmacodynamic/exposure characterisation of the multikinase inhibitor ilorasertib (ABT-348) in a phase 1 dose-escalation trial. Br J Cancer. 2018 Apr;118(8):1042-1050. doi: 10.1038/s41416-018-0020-2. Epub 2018 Mar 19.

    PubMed 29551775

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-348, ABT-348 and carboplatin and ABT-348 and docetaxel in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 2 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 12 inclusion and 7 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 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Determine the safety profile (Adverse events by toxicity grade and relationship to study drug, serious adverse events, adverse events leading to discontinuation and relevant clinical laboratory abnormalities) of ABT-348 as monotherapy or in combination (time frame: At each treatment visit). 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 NCT01110486, 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 Nov 2013.

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