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OncologyPhase 1NCT01853306

A Study to Evaluate the Safety, Pharmacokinetics and Oral Bio Availability of Veliparib in Subjects With Solid Tumors

A Phase 1 study testing Veliparib in people with Oncology and BRCA Mutated, run by AbbVie.

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

This is a 3 part phase 1 study to evaluate the safety, pharmacokinetic and oral bioavailability of veliparib in subjects with solid tumors. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Veliparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
No sites listed yet
Study dates
18 Mar 2013to 29 Jun 2017
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

  • Part 1 and 2: Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective. Subjects must also 1) have a documented BRCA1 or BRCA2 mutation that is considered to be deleterious by the investigator, OR 2) have high grade serous ovarian, fallopian tube, or peritoneal cancer. Subjects with molecular features indicative of DNA repair defects (such as mutation in the Fanconi anemia pathway genes or methylation of the BRCA1 promoter) may be considered eligible for following discussion with the medical monitor. Part 3: Histologically or cytologically confirmed breast, ovarian, fallopian tube or primary peritoneal cancer that is metastatic or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective. Platinum-resistant ovarian cancer is not permitted. Subjects must also 1) have a documented BRCA1 or BRCA2 mutation that is considered to be deleterious by the investigator and 2) have received 3 or fewer regimens of cytotoxic chemotherapy in the metastatic setting and 3) have evaluable disease as defined by RECIST 1.1 or GCIC-CA-125 criteria.
  • Subject must be at least 18 years of age.
  • Completion of last anti-cancer therapy must be at least 28 days prior to study drug administration.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
  • Subject must have adequate hematologic, renal and hepatic function as follows:
  • Bone Marrow: Absolute neutrophil count ANC ≥ 1,500/mm3 (1.5 × 109/L); Platelets ≥ 100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.5 g/dL (1.4 mmol/L). Subjects with hemoglobin ≥ 9.5 g/dL (1.4 mmol/L) following transfusion are eligible;
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  • Renal function: A calculated creatinine clearance value of ≥ 50 mL/min as determined by the Cockcroft Gault formula or a creatinine clearance value of ≥ 50 mL/min based on a 24-hour urine collection;
  • 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.
  • Women of childbearing potential and men must agree to use adequate contraception prior to the study entry, for the duration of study participation and up to 3 months following completion of therapy. Women of childbearing potential must have a negative pregnancy test within 7 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 as the preferred life style of the subject; periodic abstinence is not acceptable;
  • vasectomized partner(s);
  • hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration;
  • intrauterine device (IUD);
  • 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 completion if therapy.
  • Subject must be 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.
  • Must voluntarily sign and date each informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Who cannot join

  • The subject must not have received anti-tumor radiotherapy, biologic therapy, chemotherapy, or immunotherapy within 28 days or 5 half lives (whichever is shorter) of the start of Day 1. The subject must not have received hormonal therapy for anti-tumor purposes within 1 week prior to the start of Cycle 1 Day 1.
  • Subject must not have known untreated brain or meningeal metastases. CT scans are not required to rule out brain or meningeal metastases unless there is a clinical suspicion of central nervous system disease. Subjects with treated brain metastases that are radiographically or clinically stable for at least 4 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible, provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least one week prior to study drug administration).
  • Clinically significant and uncontrolled major medical condition(s) including but not limited to:
  • Uncontrolled nausea/vomiting/diarrhea;
  • Active uncontrolled infection;
  • Symptomatic congestive heart failure;
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  • Unstable angina pectoris or cardiac arrhythmia;
  • Psychiatric illness/social situation that would limit compliance with study requirements;
  • Focal or generalized seizure within the last 12 months.
  • Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities;
  • Subject who has received strong inhibitors or inducers of CYP3A, 1A1, 2D6, or 2C19 within 3 days or five half-lives (whichever is shorter) prior to the first dose of veliparib (applicable to Part 1 only).
  • Subject is pregnant or lactating.
  • Subjects that have previously been treated with a veliparib.
  • For Part 3, subject has ovarian cancer that was previously treated with platinum based chemotherapy resulting in progression free survival for < 6 months from the completion of treatment.
  • For Part 3, subject has received 4 or more prior lines of cytotoxic chemotherapy for systemic disease.
  • 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. Questions regarding the inclusion of individual subject should be directed to the Medical Monitor.
  • History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
  • Receipt of any investigational product within 28 days prior to study drug administration or 5 half-lives, whichever is longer.
  • Current enrollment in another clinical study.
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive veliparib.

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Oral Bioavailability of Veliparib Extended Release Formulations in Subjects With Solid Tumors

This is a 3 part phase 1 study to evaluate the safety, pharmacokinetic and oral bioavailability of veliparib in subjects with solid tumors.

Being tested
Veliparib
Keywords
High grade serous ovarian cancer, BRCA mutated breast cancer, BRCA mutated, Oncology
Medical subject headings
Neoplasms

What participants receive

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

  • VeliparibDrug

    veliparib

Study groups in NCT01853306
Study groupRoleWhat they receive
Veliparib formulation AExperimentalveliparib formulation A
Receives: Drug: Veliparib
Veliparib formulation BExperimentalVeliparib formulation B
Receives: Drug: Veliparib
Veliparib formulation CExperimentalveliparib formulation C
Receives: Drug: Veliparib

What is being measured

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

  1. Part 2 - Dose Escalation Cohort: Pharmacokinetic testing

    Cmax, Tmax ,and AUC, and safety parameters

    Measured: Up to 36 months

  2. Part 1 - Pharmacokinetic profile

    The following pharmacokinetic parameters will be analyzed: Tmax, the terminal phase elimination rate constant (β), the natural logarithms of Cmax, AUCt and AUC∞.

    Measured: Up to Day 6

  3. Part 3 - Safety Expanded Cohort: Number of subjects with adverse events

    Measured: Up to 36 months

  4. Part 3 - Safety Expanded Cohort: Vital signs

    Blood pressure, Heart rate

    Measured: Up to 36 months

  5. Part 3 - Safety Expanded Cohort: Laboratory tests

    Hematology, Chemistry, Urinalysis

    Measured: Up to 36 months

Secondary outcomes (1)

  1. The number of participants with adverse events who receive the extended release formulations of veliparib.

    Measured: Up to 36 months

Timeline

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

  1. First posted15 May 2013 (estimated)
  2. Study start18 Mar 2013
  3. Primary completion3 May 2017
  4. Study completion29 Jun 2017

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01853306
Sponsor's protocol ID
M13-695
Status last verified
Jul 2017
First submitted
22 Mar 2013
Last updated
21 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Mittapalli RK, Nuthalapati S, Delke DeBord AE, Xiong H. Development of a Level A in Vitro-in Vivo Correlation for Veliparib (ABT-888) Extended Release Tablet Formulation. Pharm Res. 2017 Jun;34(6):1187-1192. doi: 10.1007/s11095-017-2133-3. Epub 2017 Feb 27.

    PubMed 28243955

  • Werner TL, Sachdev J, Swisher EM, Gutierrez M, Kittaneh M, Stein MN, Xiong H, Dunbar M, Sullivan D, Komarnitsky P, McKee M, Tan AR. Safety and pharmacokinetics of veliparib extended-release in patients with advanced solid tumors: a phase I study. Cancer Med. 2018 Jun;7(6):2360-2369. doi: 10.1002/cam4.1488. Epub 2018 May 7.

    PubMed 29733524

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Veliparib in people with Oncology and BRCA Mutated, run by AbbVie.

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 17 inclusion and 21 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Part 2 - Dose Escalation Cohort: Pharmacokinetic testing (time frame: Up to 36 months). The study lists 5 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 NCT01853306, 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 21 Nov 2017.

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