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A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid Tumors

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ClinicalTrials.gov Identifier: NCT02033551
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is an extension study to evaluate the safety of Veliparib monotherapy or in combination with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI) in subjects with solid tumors.

Condition or disease Intervention/treatment Phase
Breast Cancer Ovarian Cancer Colon Cancer Lung Cancer Gastric Cancer Solid Tumors Drug: Veliparib Drug: Carboplatin Drug: Paclitaxel Drug: FOLFIRI Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study to Evaluate the Safety of Veliparib as Single Agent Therapy or in Combination With Chemotherapy in Subjects With Solid Tumors
Study Start Date : December 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: Arm A - Veliparib Monotherapy
Subjects in this arm will be dosed with Veliparib continuous dosing.
Drug: Veliparib
Other Name: ABT-888

Experimental: Arm B - Veliparib in Combination with Carboplatin & Paclitaxel
Subjects enrolled will receive Veliparib in combination with Carboplatin and Paclitaxel and have an option to move to Veliparib monotherapy.
Drug: Veliparib
Other Name: ABT-888

Drug: Carboplatin
Drug: Paclitaxel
Other Name: Taxol

Experimental: Arm C Veliparib in Combination with Modified FOLFIRI
Subjects will be given Veliparib in combination with modified FOLFIRI. The subject will have the opportunity to receive Veliparib as monotherapy.
Drug: Veliparib
Other Name: ABT-888

Drug: FOLFIRI
combination of Fluorouracil, leucovorin and irinotecan




Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: Measured up to 30 days after the last dose of study drug. ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Radiographic evaluation at Screening and every 6-9 weeks until the final visit, up to 18 months. ]
  2. Overall Survival (OS) [ Time Frame: Every 3 months after the subject is registered off study up to 2 years post discontinuation or until date of death from any cause, whichever comes first. ]
  3. Time to Disease Progression (TTP) [ Time Frame: Assessed at each visit up to 18 months after the last subject has enrolled in the study. ]
  4. Progression Free Survival (PFS) [ Time Frame: Radiographic evaluation starting from the first day of study drug until documented progression or date of death, whichever comes first, until the subject is registered off study. ]
  5. Clinical Laboratory Tests [ Time Frame: Up to 18 months. ]
    Hematology, Chemistry, Urinalysis

  6. Electrocardiogram [ Time Frame: Up to 18 months. ]
  7. Tumor Assessment [ Time Frame: Up to 18 months. ]
    A computerized tomography scan to document the size of the tumor.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have confirmed solid malignancy that is metastatic, and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
  • For Veliparib monotherapy (must have tumor with defects in DNA repair mechanisms (BRCA mutation or high grade ovarian cancer or solid tumors for combination therapy.
  • If the subject has known 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 Central Nervous System (CNS) disease progression as determined by comparing a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan performed during screening to a prior scan performed at least 4 weeks earlier and provided that the subject is asymptomatic, has no evidence of cavitation or hemorrhage, and does not require corticosteroids (must have discontinued steroids at least 3 months prior to study drug administration).
  • Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.

Exclusion Criteria:

  • Subject has a clinically significant and uncontrolled major medical condition(s) including but not limited to:
  • Uncontrolled seizure disorder, including focal or generalized seizure within the last 12 months;
  • Uncontrolled nausea/vomiting/diarrhea;
  • Active uncontrolled infection;
  • Symptomatic congestive heart failure;
  • Unstable angina pectoris or cardiac arrhythmia;
  • Psychiatric illness/social situation that would limit compliance with study requirements;
  • Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.
  • Subjects who have hypersensitivity to Carboplatin, Paclitaxel or Cremophor should be excluded from arm B.
  • Subject has received any of the following anti-cancer therapies 21 days prior to the first dose of study drug or a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
  • Subject who requires parenteral nutrition, tube feeding or has evidence of a partial bowel obstruction or perforation within 28 days prior to study drug.
  • The subject has had another active malignancy within the past 3 years except for any cancer in situ that the Principal Investigator considers to be cured.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033551


Locations
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United States, Arizona
Site Reference ID/Investigator# 117416
Scottsdale, Arizona, United States, 85258
United States, Texas
Site Reference ID/Investigator# 117415
San Antonio, Texas, United States, 78229
Netherlands
Site Reference ID/Investigator# 117337
Groningen, Netherlands, 9713 GZ
Site Reference ID/Investigator# 117338
Maastricht, Netherlands, 6229 HX
Spain
Site Reference ID/Investigator# 117451
Madrid, Spain, 28050
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Stacie Shepherd, PhD AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02033551     History of Changes
Other Study ID Numbers: M14-144
2013-003137-16 ( EudraCT Number )
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Keywords provided by AbbVie:
Gastric Cancer
Lung Cancer
PARP Inhibitor
Ovarian Cancer
Solid Tumors
Breast Cancer
Colon Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Stomach Neoplasms
Colonic Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Colonic Diseases
Intestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Veliparib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents