Clinical trial · Interventional
Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer
A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer
NCT00372073CI-TRIAL-00055638terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| seliciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1 with seliciclib
- description
- Oral seliciclib at 1200mg b.i.d. for 3 consecutive days as an outpatient beginning on day 1 every 2 weeks for 3 cycles as run-in. Patients (randomized) continue on treatment if derived clinical benefit during run-in period.
- interventionNames
- Drug: seliciclib
- type
- PLACEBO_COMPARATOR
- label
- Arm 2 with placebo control
- description
- Randomized to placebo after run-in period.
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with histologically-confirmed recurrent non-small cell lung cancer have had at least two prior systemic treatment regimens * Must have measurable disease according to RECIST * Eastern Cooperative Oncology Group performance status 0-1 * Adequate bone marrow, hepatic and renal function * Ability to swallow capsules * At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, at least 7 days from prior radiation therapy and have recovered from prior toxicities * At least 3 weeks from major surgery Exclusion Criteria: * Non-small cell cancer histology contains a component of small cell lung cancer * Previously untreated CNS metastasis or progressive CNS metastasis * Prior treatment with a CDK inhibitor * Currently receiving radiotherapy, biological therapy, or any other investigational therapy * Uncontrolled intercurrent illness * Having other cancers that have been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer or basal cell skin cancer * Pregnant or lactating women * Known to be HIV-positive * Active hepatitis B and/or hepatitis C infection
References
Publications (1)
- DERIVEDMalumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602. PMID 19238148