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Prostate CancerPhase 1NCT01085422

A Study Combining ABT-888, Oral PARP Inhibitor, With Temozolomide in Patients With Metastatic Prostate Cancer

A Phase 1 study testing ABT-888 and temozolomide in people with Prostate Cancer, run by AbbVie (prior sponsor, Abbott).

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 temozolomide (TMZ) has activity in subjects with metastatic castration resistant prostate cancer (CRPC) as reflected by the prostate-specific antigen (PSA) response. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
ABT-888 and temozolomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
Apr 2010to Jun 2011
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has histologically or cytologically confirmed prostate cancer.
  • Metastatic prostate cancer with measurable and/or bony disease that has progressed despite androgen deprivation therapy and at least one and no more than two prior systemic non hormonal therapies (at least one must include docetaxel) for castration resistant metastatic disease.
  • At least 28 days must have elapsed since completion of prior anti-cancer therapy and must have recovered from all side effects to < Grade 1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. ECOG PS 3 is allowed if due to pain.
  • Subjects must have PSA progression defined as:
  • A 25% increase in PSA over a baseline value with an increase in the absolute value of PSA level by 2 ng/ml, that is confirmed by another PSA level at a minimum of 1 week interval.
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  • Subjects must have a minimum PSA of > 2 ng/ml.
  • Testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with a luteinizing hormone-releasing hormone (LHRH) analogue if they have not undergone orchiectomy.
  • No investigational or commercial agents (other than LHRH analogue) or therapies including other hormonal agents such as antiandrogens or herbal medications may be administered with the intent to treat the subject's malignancy. Subjects on stable doses of steroids or megestrol acetate (for hot flashes or appetite) are allowed.
  • Four weeks must have elapsed since major surgery.
  • Prior radiotherapy is allowed as long as the bone marrow function is adequate and at least 4 weeks has elapsed since completion of radiation therapy. No prior radiopharmaceuticals are allowed.
  • Subjects must have normal organ and bone marrow function as defined below obtained within two weeks from treatment initiation:
  • Bone Marrow: absolute neutrophil count ≥ 1,500/mcL; platelets ≥ 100,000/mcL; hemoglobin ≥ 9.0 g/dL
  • Renal function: Serum creatinine ≤ 1.5 × upper limits of institution's normal (ULIN) range or creatinine clearance ≥ 50 mL/min/1.73 m2
  • Hepatic Function: Aspartate aminotransferase (AST) and/or alanine transaminase (ALT) ≤ 2.5 × ULIN. For subjects with liver metastases, AST and/or ALT < 5 × ULIN. Bilirubin ≤ 1.5 × ULIN (Subjects with Gilbert's Syndrome may have a bilirubin ≥ 1.5 × ULIN)
  • Subjects who refuse to provide blood samples for the correlative studies will be eligible.
  • ABT-888 and temozolomide are known to be teratogenic, therefore men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  • Subjects with treated and controlled epidural disease are permitted into the study.
  • 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.

Who cannot join

  • A subject with cord compression or a history of uncontrolled central nervous system (CNS) metastases or leptomeningeal disease.
  • Subject has had prior therapies with Dacarbazine (DTIC) or TMZ containing regimens.
  • The subject has received an investigational agent within 28 days prior to study drug administration.
  • Subject with a history of seizure disorder and currently receiving medications for seizure disorders (e.g., steroid or anticonvulsant drugs).
  • The subject has had another active malignancy within the past 1 year with the exception of definitely treated carcinomas in situ, superficial bladder cancer, and non-melanoma carcinoma of the skin. Questions regarding inclusion of individual subjects should be discussed with the Abbott Medical Monitor.
  • Clinically significant and uncontrolled major medical condition(s) including but not limited to:
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  • active uncontrolled infection,
  • symptomatic congestive heart failure,
  • unstable angina pectoris or cardiac arrhythmia,
  • Psychiatric illness/social situation that would limit compliance with study requirements,
  • Or any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities.
  • Subject has previously been treated with a PARP inhibitor.

About this study

Official title: A Pilot Study Combining ABT-888, an Oral PARP Inhibitor, With Temozolomide in Patients With Metastatic Castration Resistant Prostate Cancer Who Have Failed Up to Two Non-hormonal Systemic Therapies

Assess whether the combination of ABT-888 with temozolomide (TMZ) has activity in subjects with metastatic castration resistant prostate cancer (CRPC) as reflected by the prostate-specific antigen (PSA) response.

Conditions
Prostate Cancer
Being tested
ABT-888, temozolomide
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • ABT-888Drug

    Also called ABT-888, veliparib

    Subjects will be given ABT-888 on Days 1 -7 every 28 days orally and temozolomide on days 1-5 on days 1-5 every 28 days orally with ABT-888

  • temozolomideDrug

    Subjects will be given ABT-888 40 mg twice daily on Days 1 -7 every 28 days orally and temozolomide on days 1-5 every 28 days orally with ABT-888

Study groups in NCT01085422
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Drug: ABT-888; Drug: temozolomide

What is being measured

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

  1. Protein-specific antigen (PSA) test

    This is performed to assess if ABT-888 combined with temozolomide has activity in patients with prostate cancer as reflected by the prostate-specific antigen (PSA).

    Measured: Day 0 through investigator-determined discontinuation (final visit)

Secondary outcomes (2)

  1. Assessment of Efficacy

    Evaluate the safety and tolerability of the combination therapy through safety assessments (i.e. electrocardiogram (ECG), clinical laboratory tests, vital signs, Adverse Event assessments, serious adverse events, physical exams, computed tomography (CT) scans)

    Measured: Day 0 through investigator-determined discontinuation

  2. Assessment of Safety

    Assess the objective response rate (ORR), PSA decline, time to progression (TTP), progression free survival (PFS), and overall survival (OS)

    Measured: Day 0 through survival follow-up

Timeline

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

  1. First posted11 Mar 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01085422
Sponsor's protocol ID
M11-070
Status last verified
Jan 2013
First submitted
10 Mar 2010
Last updated
21 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Hussain M, Carducci MA, Slovin S, Cetnar J, Qian J, McKeegan EM, Refici-Buhr M, Chyla B, Shepherd SP, Giranda VL, Alumkal JJ. Targeting DNA repair with combination veliparib (ABT-888) and temozolomide in patients with metastatic castration-resistant prostate cancer. Invest New Drugs. 2014 Oct;32(5):904-12. doi: 10.1007/s10637-014-0099-0. Epub 2014 Apr 26.

    PubMed 24764124

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-888 and temozolomide in people with Prostate Cancer, run by AbbVie (prior sponsor, Abbott).

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 19 inclusion and 12 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?

Protein-specific antigen (PSA) test (time frame: Day 0 through investigator-determined discontinuation (final 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 NCT01085422, which also lists 1 linked publication.

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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