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Safety Study of ABT-263 in Combination With Carbo-Taxol (Carboplatin/Paclitaxel) in Subjects With Solid Tumors
This study is not yet open for participant recruitment.
Verified by Abbott, April 2009
First Received: April 29, 2009   Last Updated: April 30, 2009   History of Changes
Sponsors and Collaborators: Abbott
Genentech
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00891605
  Purpose

The is a Phase 1 study assessing the safety profile of ABT-263 in combination with Carbo-taxol, studying the pharmacokinetic interaction between ABT-263 with Carbo-taxol and to determine the maximum tolerated dose (MTD) of ABT-263 in combination with Carbo-taxol.


Condition Intervention Phase
Solid Tumor
Drug: ABT-263
Drug: paclitaxel
Drug: Carboplatin
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Paclitaxel Carboplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Carbo-Taxol (Carboplatin/Paclitaxel) in the Treatment of Subjects With Solid Tumors

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule of ABT 263 in combination with Carbo-taxol [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate preliminary data regarding objective response rate (ORR), progression free survival (PFS), time to tumor progression (TTP), overall survival (OS), duration of overall response, and ECOG performance status [ Time Frame: Bi-Monthly ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: April 2009
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Carbo-taxol (Carboplatin/Paclitaxel): Experimental Drug: paclitaxel
175 mg/m2 over 3 hours of paclitaxel will be given by intravenous infusion on Day 1 of each 21 day cycle
Drug: Carboplatin
Carboplatin (AUC 6 over 1 hour) will be given by intervenous infusion on Day 1 immediately after the paclitaxel infusion.
ABT-263: Experimental Drug: ABT-263
150 mg of ABT-263 is taken orally once daily on Days 1-5 out of each 21 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years. Histologically and/or cytologically documented cancer for which carbo-taxol has been determined an appropriate therapy, per Investigator.
  • 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.
  • ECOG < 1.
  • Must have adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:

    • Bone marrow:Absolute Neutrophil Count≥1500/μL
    • Platelets ≥ 150,000/mm3
    • Hemoglobin ≥ 9.0 g/dL
  • Renal function: Serum creatinine ≤ 1.2 mg/dL or calculated creatinine clearance ≥ 50 mL/min
  • Hepatic function and enzymes:

    • AST
    • ALP and ALT ≤ 3.0 × the upper limit of normal (ULN)
    • Bilirubin ≤ 1.25 × 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 ≤ 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 > 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).

Exclusion Criteria:

  • Predisposing condition/currently exhibits signs of bleeding.
  • Recent history of thrombocytopenia associated with bleeding.
  • Currently receiving/requires anticoagulation therapy/any drugs/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/ 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 of 1st dose of study drug).
  • Received radio-immunotherapy w/i 6 months of 1st dose of study drug. Received antibody therapy or other biologics (with the exception of colony stimulating factors or erythropoietin) w/i 28 days of 1st dose of study drug.
  • Received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal therapy (with some exceptions), or any investigational therapy w/i 14 days of 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 of the 1st dose of study drug (Inhaled steroids for asthma, topical steroids, replacement/stress corticosteroids, or corticosteroids taken as premedication are allowed).
  • Received aspirin w/i 7 days of 1st dose of study drug. History of hypersensitivity to Taxol or severe allergic reactions to cisplatin or other platinum-containing compounds.
  • 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 of study drug administration.

  • A history of other active malignancies within the past 3 years prior to screening, 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891605

Contacts
Contact: Alexis A Cunningham, B.A. 847-937-1225 alexis.cunningham@abbott.com
Contact: Julie Sicam, B.S. 847-937-5363 julie.sicam@abbott.com

Locations
United States, New Jersey
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Abbott
Genentech
Investigators
Study Director: Andrew Krivoshik, MD, PhD Abbott
  More Information

No publications provided

Responsible Party: Abbott ( Andrew Krivoshik, MD, PhD, Medical Director )
Study ID Numbers: M10-589
Study First Received: April 29, 2009
Last Updated: April 30, 2009
ClinicalTrials.gov Identifier: NCT00891605     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Carboplatin
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Paclitaxel
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Carboplatin
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009