Clinical trial · Interventional
Study to Evaluate SID 530 Compared to Taxotere
A Randomized, Double-Blind, Two-Way Crossover, Bioequivalence Study of SID530 and Taxotere® in Study Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Platinum Therapy Failure or Study Participants With Locally Advanced or Metastatic Breast Cancer Who Have Failed At Least One Prior Chemotherapeutic Regimen
- 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 multi-center, randomized, blinded, two-period, two-sequence, crossover study, with a minimum 3-week washout period between treatments.The study is designed to evaluate the bioequivalence of SID530 to Taxotere. It will be conducted in study participants with locally advanced or metastatic NSCLC who have failed platinum therapy and also in participants with locally advanced or metastatic breast cancer who have failed at least one line of chemotherapy. Eligible study participants must be planning to have at least two consecutive 21-day cycles with 75 mg/m2 docetaxel monotherapy. The duration of study participation will be approximately 7 weeks. The study has three study phases: Screening (\<=1 week), Cycle 1 (21 days), and Cycle 2 (21 days).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SID530, Taxotere | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SID530
- description
- Study participants who meet eligibility criteria will be randomized to one of two treatment sequences, SID530 or Taxotere (i.e., SID530 on Day 1 followed by Taxotere on Day 21 or Taxotere on Day 1 followed by SID530 on Day 21)
- interventionNames
- Drug: SID530, Taxotere
- type
- ACTIVE_COMPARATOR
- label
- Taxotere
- description
- Study participants who meet eligibility criteria will be randomized to one of two treatment sequences, SID530 or Taxotere (i.e., SID530 on Day 1 followed by Taxotere on Day 21 or Taxotere on Day 1 followed by SID530 on Day 21)
- interventionNames
- Drug: SID530, Taxotere
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:Study participants * Has provided written informed consent * Is at least 18 years of age * Has histologically or cytologically confirmed non-small cell lung (NSCLC) or breast cancer (BC) that is locally advanced or metastatic * Has at least two planned consecutive 21-day cycles with 75 mg/m2 docetaxel monotherapy * Has a life expectancy of at least 3 months * Has Eastern Cooperative Oncology Group Performance Scale (ECOG PS) is in the range of 0-2 at the time of randomization * Has the Proper laboratory values within 1 week prior to randomization * Has negative serum pregnancy test within 1 week before first study drug administration (for women of childbearing potential, only) * Is willing to practice medically accepted contraception (if the risk of conception exists) throughout the study period (from Screening until the Final Visit) Exclusion Criteria:Study participants * Has had any chemotherapy within 4 weeks before date of first study treatment * Has experienced severe side effects from (or severe hypersensitivity to) prior docetaxel treatment (or other drugs formulated with polysorbate 80, hydroxypropylbetadex, or povidone) such that discontinuation of the treatment was required * Has a history of hypersensitivity to dexamethasone * Is pregnant, lactating, or breastfeeding * Is taking one or more compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4 * Has had treatment in another clinical study within the past 30 days * Has medical or psychological conditions that would not permit the study participant to complete the study or sign informed consent * Is unlikely to comply with the protocol requirements, instructions and study-related restrictions * Has any other disease, dysfunction (including alcohol or drug abuse), physical examination or laboratory finding which, in the investigator's opinion, would exclude the participant from the study
References
Publications (0)
Data not yet available