Clinical trial · Interventional
Dinaciclib in Treating Patients With Stage IV Melanoma
A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma
NCT00937937CI-TRIAL-00112938active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acral Lentiginous Melanoma | Acral Lentiginous Melanoma | ONTOLOGY_EXACT | 0.98 |
| Cutaneous Nodular Melanoma | Cutaneous Nodular Melanoma | ONTOLOGY_EXACT | 0.98 |
| Lentigo Maligna Melanoma | Lentigo Maligna Melanoma | ONTOLOGY_EXACT | 0.98 |
| Low-CSD Melanoma | Low-CSD Melanoma | ONTOLOGY_EXACT | 0.98 |
| Mucosal Melanoma | Mucosal Melanoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IV Cutaneous Melanoma AJCC v6 and v7 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dinaciclib | Drug | Dinaciclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Dinaciclib
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Weekly, up to 3 years
- description
- From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Secondary outcomes (3)
- measure
- Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-confirmed malignant melanoma * Stage IV disease * Cutaneous or mucosal origin * Melanoma of unknown primary allowed * No ocular melanoma * Measurable or non-measurable disease * No prior or concurrent brain metastases as confirmed by CT scan or MRI * Zubrod performance status 0-1 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (including patients with hepatic metastases) * SGOT or SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastases) * Serum creatinine ≤ 1.5 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years * No prior therapy with a cyclin-dependent kinase inhibitor * At least 14 days since prior radiotherapy * At least 28 days since prior systemic chemotherapy * At least 28 days since prior adjuvant systemic therapy * At least 28 days since prior surgery * No more than 1 prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy, or a combination regimen) for stage IV melanoma and any side effects must have resolved to ≤ grade 1 * Any number of prior adjuvant systemic therapy regimens allowed, including interferon alfa-2b, GM-CSF, chemotherapy, and chemobiotherapy * Therapy for stage IV resected free-of-disease will be considered adjuvant therapy * Prior radiotherapy allowed provided any side effects have resolved to ≤ grade 1 * Prior surgery (for both the primary and stage IV disease) allowed provided side effects have resolved to ≤ grade 1 * No other concurrent or planned non-study treatment (including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy) * No concurrent CYP3A4 inhibitors or inducers * No concurrent grapefruit or grapefruit juice
References
Publications (1)
- DERIVEDLao CD, Moon J, Ma VT, Fruehauf JP, Flaherty LE, Bury MJ, Martin WG, Gross H, Akerley W, Hopkins JO, Patel SP, Sondak VK, Ribas A. Southwest Oncology Group S0826: A phase 2 trial of SCH 727965 (NSC 727135, dinaciclib) in patients with stage IV melanoma. Cancer. 2025 Jan 1;131(1):e35587. doi: 10.1002/cncr.35587. Epub 2024 Sep 29. PMID 39342463