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Gastric CancerPhase 1NCT01123876

Evaluating the Safety and Tolerability of the Poly-ADP Ribose (PARP) Inhibitor With FOLFIRI in Subjects With Solid Tumor

A Phase 1 study testing Veliparib in people with Gastric Cancer, run by AbbVie (prior sponsor, Abbott) at 8 sites in 2 countries.

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

Assess whether the combination of ABT-888 with FOLFIRI has activity in subjects with gastric cancer. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Gastric Cancer
What is being tested?
Veliparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
8 sitesin 2 countries
Study dates
Mar 2010to Jan 2015
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

  • Subject must be at least 18 years of age.
  • Subjects in the dose escalation cohorts must have: * Subjects with histologically or cytologically confirmed malignancy that is meta static or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective or for whom treatment with FOLFIRI is a viable option.
  • Subjects in the expanded safety cohort must have: * Histological confirmed advanced colorectal cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
  • Subject must have adequate hematologic, renal and hepatic function as follows: * Bone Marrow: Absolute neutrophil count ANC >= 1,500/mm3; Platelets >= 100,000/mm3; Hemoglobin >= 9.5 g/dL; * Renal function: Serum creatinine < 1.5 * upper normal limit of institution's normal range OR creatinine clearance <= 50 mL/min/1.73m2 for subjects with creatinine levels above institutional normal; * Hepatic function: AST and ALT <= 2.5 * the upper normal limit of institution's normal range. For subjects with liver metastases, AST and ALT <= 5 * the upper normal limit of institution's normal range; * Bilirubin <= 1.5 * the upper normal limit of institution's normal range;
  • Partial Thromboplastin Time (PTT) must be <= 1.5 * the upper normal limit of institution's normal range and INR < 1.5. Subjects on anticoagulant (such as Coumadin) will have PTT and INR as determined by the investigator.
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  • Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for 90 days following completion of therapy. Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to initiation of treatment and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non childbearing potential. * Total abstinence from sexual intercourse (minimum one complete menstrual cycle); * Vasectomized partner of female subjects; * Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration; * Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream); * IUD (Intra-Uterine Device); * Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 90 days following completions of therapy.
  • Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
  • The subject has received up to 3 prior DNA damaging agents or cytotoxic chemotherapy treatments (prior therapies with biologic agents including, IL -2, interferon, vaccines, immunostimulants and signal transduction inhibitors are allowed) Chemotherapy received as adjuvant therapy before 2 years will not be considered as prior chemotherapy.

Who cannot join

  • Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within 28 days prior to study drug administration. Subjects receiving hormone therapy, bisphosphonates or LHRH-agonists are eligible. Subjects who have not recovered to within one grade level (not to exceed Grade 2) of their baseline following a significant adverse event or toxicity attributed to previously anti-cancer treatment are excluded.
  • Subjects in the expanded safety cohorts only, have previously been treated with a PARP inhibitor.
  • Subjects with a known history of brain metastases and primary CNS tumors
  • Subjects with a known hypersensitivity to CPT11, 5-FU or Folinic Acid.
  • Clinically significant and uncontrolled major medical condition(s) including but not limited to: * 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. * Gilbert's Syndrome * Any medical condition, which in the opinion of the study investigator, places the patient at an unacceptably high risk for toxicities
  • Subjects that are being treated with Ketoconazole, enzyme-inducing anticonvulsants, and or St. John's Wort.
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  • Subject is pregnant or lactating.
  • Subject who requires parenteral nutrition, tube feeding or has evidence of partial bowel obstruction or perforation within 28 days prior to study drug administration.
  • 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.
  • Previous exposure to Irinotecan.

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States6 sites

  • Site Reference ID/Investigator# 24922

    Durham, North Carolina, 27710

  • Site Reference ID/Investigator# 24985

    Los Angeles, California, 90033

  • Site Reference ID/Investigator# 26742

    Los Angeles, California, 90033

  • Site Reference ID/Investigator# 24983

    Nashville, Tennessee, 37232-6868

  • Site Reference ID/Investigator# 24987

    Scottsdale, Arizona, 85258

  • Site Reference ID/Investigator# 24986

    Washington D.C., District of Columbia, 20007

Other trials in United States

South Korea2 sites

  • Site Reference ID/Investigator# 75713

    Seoul, 138-736

  • Site Reference ID/Investigator# 75714

    Seoul

Other trials in South Korea

About this study

Official title: A Phase 1 Open-Label, Dose-Escalation Study of Veliparib in Combination With Bimonthly FOLFIRI in Subjects With Advanced Solid Tumors

Assess whether the combination of ABT-888 with FOLFIRI has activity in subjects with gastric cancer.

Conditions
Gastric Cancer
Being tested
Veliparib
Keywords
Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • VeliparibDrug

    Also called ABT-888, Veliparib

    Subjects will be given Veliparib twice daily on Days 1-5 and 15-19 every 28 days orally

Study groups in NCT01123876
Study groupRoleWhat they receive
Veliparib and FOLFIRIExperimentalVeliparib in combination with FOLFIRI regimen.
Receives: Drug: Veliparib

What is being measured

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

  1. Determine the MTD and establish the recommended phase 2 dose of Veliparib in combination with two different FOLFIRI regimens that include a reduced regimen (150 mg/m2 irinotecan) and the standard regimen (180 mg/m2) in subjects with advanced solid tumors

    Measured: Screening to follow up visit

Secondary outcomes (1)

  1. To assess the safety and tolerability, pharmacokinetic profile of the combination at each of the FOLFIRI regimens.

    Measured: Screening to follow up visit

Timeline

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

  1. First posted14 May 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionJan 2015
  4. Study completionJan 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01123876
Sponsor's protocol ID
M10-977
Status last verified
Jul 2021
First submitted
9 Apr 2010
Last updated
2 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • Jou E, Rajdev L. Current and emerging therapies in unresectable and recurrent gastric cancer. World J Gastroenterol. 2016 May 28;22(20):4812-23. doi: 10.3748/wjg.v22.i20.4812.

    PubMed 27239108

  • Berlin J, Ramanathan RK, Strickler JH, Subramaniam DS, Marshall J, Kang YK, Hetman R, Dudley MW, Zeng J, Nickner C, Xiong H, Komarnitsky P, Shepherd SP, Hurwitz H, Lenz HJ. A phase 1 dose-escalation study of veliparib with bimonthly FOLFIRI in patients with advanced solid tumours. Br J Cancer. 2018 Apr;118(7):938-946. doi: 10.1038/s41416-018-0003-3. Epub 2018 Mar 12.

    PubMed 29527010

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Veliparib in people with Gastric Cancer, run by AbbVie (prior sponsor, Abbott) at 8 sites in 2 countries.

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 9 inclusion and 10 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 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, South Korea. 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 MTD and establish the recommended phase 2 dose of Veliparib in combination with two different FOLFIRI regimens that include a reduced regimen (150 mg/m2 irinotecan) and the standard regimen (180 mg/m2) in subjects with advanced solid tumors (time frame: Screening to follow up visit). 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 NCT01123876, which also lists 2 linked publications.

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 2 Aug 2021.

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