Clinical trial · Interventional
Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies
A Phase I, Open Label, Dose Escalation Study of Oral Administration of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies
NCT01351350CI-TRIAL-00039963completedPhase 1Results postedClinicalTrials.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)
This is a Phase I, open label, dose escalation study of oral administration of MLN0128 in combination with paclitaxel, with/without trastuzumab, in participants with advanced solid malignancies.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignancies | — | UNRESOLVED | — |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MLN0128 | Drug | Sapanisertib | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- MLN0128P 30 mg QW
- description
- MLN0128 and paclitaxel (MLN0128P): MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase.
- interventionNames
- Drug: MLN0128
- Drug: paclitaxel
- type
- EXPERIMENTAL
- label
- MLN0128P 40 mg QW
- description
- MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase.
- interventionNames
- Drug: MLN0128
- Drug: paclitaxel
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntary written consent * Locally advanced or metastatic solid tumors with the exception of primary brain tumor, and have failed or are not eligible for standard of care therapy * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Ability to swallow oral medications * For women of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to 30 days following the last study drug administration * Male participants must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration * Clinical laboratory values as specified in the protocol * For expansion phase (Arm A) - HER2-/unknown participants will be enrolled * For expansion phase (Arm B) - HER2+ cancer participants will be enrolled Exclusion Criteria: * Diagnosis of primary brain tumor * Have received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug * Known impaired cardiac function or clinically significant cardiac disease * Known treatment with systemic corticosteroid within one week prior to the first administration of study drug * Diabetes mellitus * Human immunodeficiency virus (HIV) infection * Known active cardiovascular disease condition as specified in protocol * Pregnancy (positive serum or urine pregnancy test) or breast feeding * Malabsorption due to prior gastrointestinal (GI) surgery, GI disease * Other clinically significant co-morbidities Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria. Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons
References
Publications (1)
- DERIVEDBurris HA 3rd, Kurkjian CD, Hart L, Pant S, Murphy PB, Jones SF, Neuwirth R, Patel CG, Zohren F, Infante JR. TAK-228 (formerly MLN0128), an investigational dual TORC1/2 inhibitor plus paclitaxel, with/without trastuzumab, in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2017 Aug;80(2):261-273. doi: 10.1007/s00280-017-3343-4. Epub 2017 Jun 10. PMID 28601972