Clinical trial · Interventional
ABT-888 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors
Phase I Study of ABT-888 in Combination With Gemcitabine in Patients With Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I trial is studying the side effects and best dose of giving ABT-888 together with gemcitabine hydrochloride in treating patients with advanced solid tumors. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with gemcitabine hydrochloride may kill more tumor cells.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Solid Neoplasm | Adult Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| BRCA1 Mutation Carrier | — | UNRESOLVED | — |
| BRCA2 Mutation Carrier | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
| Pharmacological Study | Other | — | UNRESOLVED |
| Veliparib | Drug | Veliparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (gemcitabine hydrochloride and ABT-888)
- description
- Patients receive oral ABT-888 twice daily on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 21\* days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: Diagnostic Laboratory Biomarker Analysis
- Drug: Gemcitabine Hydrochloride
- Other: Pharmacological Study
- Drug: Veliparib
Primary outcomes (1)
- measure
- MTD of ABT-888 and gemcitabine hydrochloride, determined according to incidence of DLT graded using the NCI CTCAE version 4.0
- timeFrame
- 3 weeks
Secondary outcomes (3)
- measure
- Adverse events as assessed by NCI CTCAE v 4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed solid tumors meeting 1 of the following criteria:
* Progressive disease following standard therapy
* Disease for which acceptable standard treatment options do not exist
* May have received 0-2 prior chemotherapeutic regimens (single-agent or combination chemotherapies)
* Willing to undergo BRCA mutation analysis
* Known BRCA mutations allowed
* All patients, at any dose level, without a known BRCA mutation undergo screening with the BRCAPRO program to assess the likelihood of having a BRCA mutation
* Patients with a BRCAPRO likelihood of gene mutation of ≥ 20% must undergo BRCA gene testing by the Myriad Genetic Laboratories in order to participate in the study
* Patients are eligible whether they have a known deleterious BRCA 1 or 2 mutation or a mutation of uncertain significance
* No CNS disease (e.g., brain metastases or glioma)
* No active seizure or history of seizure disorder
* ECOG performance status 0-2 (Karnofsky 60-100%)
* Life expectancy \> 3 months
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin \< 2.0 mg/dL
* AST and ALT \< 3 times upper limit of normal
* Creatinine normal OR creatinine clearance \> 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to swallow pills
* HIV-positive patients allowed provided that CD4 counts are \< 500 and not on protease inhibitors
* No uncontrolled diarrhea
* No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situations that would limit compliance with study requirements
* No other concurrent anticancer therapies or agents
* More than 4 weeks since prior major surgery, radiotherapy, or chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered
* Prior gemcitabine hydrochloride or PARP inhibition therapy, including ABT-888, allowed
* No prior combination of gemcitabine hydrochloride and any PARP inhibitor
* Concurrent bisphosphonate IV allowed provided treatment was initiated before study therapy (for patients with bone metastases or hypercalcemia)
* Patients with prostate cancer must continue luteinizing-hormone releasing-hormone agonist therapy and discontinue antiandrogens (≥ 6 weeks since bicalutamide and ≥ 4 weeks since flutamide)
* No other concurrent investigational agentsReferences
Publications (1)
- DERIVEDManzo J, Puhalla S, Pahuja S, Ding F, Lin Y, Appleman L, Tawbi H, Stoller R, Lee JJ, Diergaarde B, Kiesel BF, Yu J, Tan AR, Belani CP, Chew H, Garcia AA, Morgan RJ, Wahner Hendrickson AE, Visscher DW, Hurley RM, Kaufmann SH, Swisher EM, Oesterreich S, Katz T, Ji J, Zhang Y, Parchment RE, Chen A, Duan W, Giranda V, Shepherd SP, Ivy SP, Chu E, Beumer JH; ETCTN-8282 study team. A phase 1 and pharmacodynamic study of chronically-dosed, single-agent veliparib (ABT-888) in patients with BRCA1- or BRCA2-mutated cancer or platinum-refractory ovarian or triple-negative breast cancer. Cancer Chemother Pharmacol. 2022 May;89(5):721-735. doi: 10.1007/s00280-022-04430-6. Epub 2022 Apr 18. PMID 35435472