ABT-348 as Monotherapy or Combination With Carboplatin or Docetaxel to Treat Advanced Solid Tumors
NCT ID: NCT01110486
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
102 participants
INTERVENTIONAL
2010-03-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Monotherapy, once daily
ABT-348
An oral dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.
Combination with carboplatin
ABT-348 and carboplatin
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.
Combination with docetaxel
ABT-348 and docetaxel
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.
Monotherapy, twice daily
ABT-348
An oral dose of ABT-348, twice daily on Day 1, Day 8, and Day 15 of each 28 day cycle
IV Monotherapy, once daily
ABT-348
An IV administration of ABT-348 two hour infusion on Day 1, Day 8 and Day 15 of each 28 day cycle.
Interventions
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ABT-348
An oral dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.
ABT-348 and carboplatin
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 docetaxel
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-348
An oral dose of ABT-348, twice daily on Day 1, Day 8, and Day 15 of each 28 day cycle
ABT-348
An IV administration of ABT-348 two hour infusion on Day 1, Day 8 and Day 15 of each 28 day cycle.
Eligibility Criteria
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Inclusion Criteria
* 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.
2. Eastern Cooperative Oncology Group Status of 0-2
3. 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
4. Adequate liver function as demonstrated by serum bilirubin \< 2 x ULN and AST and ALT ≤ 2.5 x ULN
5. 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)
6. QTc interval \< 500 msec
7. Left Ventricular Ejection Fraction \> 50%
8. 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.
9. 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.
Exclusion Criteria
2. Subject has received anti-cancer therapy within a period of 21 days or 5 half lives (whichever is shorter) prior to Study Day 1
3. Subject has unresolved toxicities from prior anti-cancer therapy, grade 2 or higher clinically significant toxicity (excluding alopecia)
4. Subject has had major surgery within 28 days prior to Study Day 1
5. Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure \> 90 mmHg or systolic blood pressure \> 140 mmHg
6. 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)
18 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Gary Gordon, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 26525
Chicago, Illinois, United States
Site Reference ID/Investigator# 26524
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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M10-944
Identifier Type: -
Identifier Source: org_study_id